bluuebunny/crossref_metadata_2025 huggingface dataset:
The effect of tooth brushing counseling on increasing knowledge of dental and oral health of physical education teachers
Authors: Haryani Wiworo , Putri Shanti Yolanda , Widayati Aryani
Published: January 2023

Background: Dental and oral health requires comprehensive handling. Prevention of dental and oral diseases can be done by providing dental health education from an early age, counseling is very effective in improving the level of dental and oral health. Purpose: To determine the effect of brushing counseling on dental and oral health knowledge of elementary physical education teachers in Padang Panjang. Methods: This type of research is a quasi-experimental research with a total sampling technique with a total population of 42 physical education teachers, 21 people are included in the experimental group, namely the group that is given counseling and 21 others are included in the control group, namely the group that is given counseling using leaflet media. This study uses the Wilcoxon Signed Ranks Test hypothesis test. Results: The level of knowledge of dental and oral health before counseling was 33.3% in good criteria, 47.6% enough and 19.0% less and after counseling it became a good category that is, 90.5%, enough 9.5% and less as much as 0 %. The Wilcoxon Signed Ranks Test results showed significant value of 0.000 and 0.000 <0.05. Conclusion: Counseling teeth brushing an effects on increasing knowledge of oral and dental health on physical education teachers
Educational Model: Anti-Stroke Gymnastics on Compliance and Health Status of Patients Hypertension
Authors: Manurung Santa
Published: January 2023

Background: The prevalence of hypertension continues to increase, various epidemiological studies show an increase in the incidence and prevalence of hypertension in various parts of the world. According to the American Heart Association (AHA), the American population aged over 20 years suffering from hypertension has reached up to 74.5 million people, but almost 90% of cases have no known cause. Hypertension is a silent killer where the symptoms can vary in each individual and are almost the same as the symptoms of other diseases. In Indonesia, the problem of hypertension is a big challenge, because hypertension is very often found in primary health services with a high prevalence. Hypertension if not handled properly can cause damage to blood vessels throughout the body and the most obvious is the risk of damage to the brain, eyes, heart, and kidney disease. These risks can be avoided and minimized by pharmacological and non-pharmacological management. Anti-stroke exercise is one of the gymnasticsthat is useful to prevent the risk of stroke in someone who suffers from hypertension. This research is a quasi experiment with pre-post test with control group design. This study aims to determine the effect of anti-stroke gymnastics education on adherence and health status of patients with hypertension. The sampling technique was simple random sampling and the determination of the sample size was using the hypothesis test of the average difference in two independent groups. Data processing and analysis in this study used paired t-test and independent t-test. The results showed that there were significant differences in knowledge, patient compliance, decreased blood pressure and health status of hypertension patients after anti-stroke gymnastics was performed. It is recommended that anti-stroke gymnastics can be used as a non-pharmacological therapy to treat hypertension patients to prevent stroke.
Neuroprotective Effect of Withania Somnifera Root Extract In Type 2 Diabetes Mellitus Induced Cognitive Impairment And Neurodegeneration In Rats
Authors: Tanwar Anshul , Gulati Kavita , Ray Arunabha
Published: January 2023

The present study was conducted to assess the effects of Withania somnifera root extract (WS) on cognitive deficit and neurodegeneration induced by type 2 diabetes mellitus in rats. Type 2 diabetes mellitus (T2DM) was induced in rats by feeding them high fat diet (HFD) for 8 weeks followed by intraperitoneal administration of low dose Streptozotocin (STZ; 35 mg/kg). After four weeks of STZ administration the levels of metabolic parameters (fasting blood glucose, serum triglycerides and serum total cholesterol) were measured to confirm the development of diabetes. WS and Pioglitazone (PZ) were administered daily for 8 weeks to the diabetic rats. At the end of the treatment, behavioural analysis was done to observe the effects of diabetes on memory by Morris water maze (MWM) test. Thereafter, animals were sacrificed; blood and brain samples were collected for biochemical analysis. Metabolic parameters (fasting blood glucose, serum triglycerides and total cholesterol) were found to be significantly elevated in diabetic rats as compared to normal control animals; treatment with WS and PZ for 8 weeks significantly lowered these levels. In MWM test, mean escape latency time (ELT) on day 4 was found to be increased and time spent in the target quadrant (TSTQ) on day 5 was reduced significantly in DC rats as compared to NC. However, TSTQ increased significantly and mean ELT was found to be decreased in the rats treated with WS at the dose of 100 and 300 mg/kg for 8 weeks as compared to DC rats. The level of Aβ1-42, a main component of amyloid plaques, was found to be increased significantly in hippocampus and prefrontal cortex of DC rats as compared to NC and treatment with WS lowered the levels of Aβ1-42. Further, the level of brain-derived neurotrophic factor (BDNF) was found to be reduced significantly in diabetic rats whereas WS treated groups showed a significant increase in BDNF. The data suggests that treatment with standardized root extract of Withania somnifera normalized the elevated metabolic parameters in diabetic animals when compared with untreated diabetic animals and the results were comparable with pioglitazone. Also it was found that T2DM adversely affects memory and cause neurodegeneration. WS treatment showed neuroprotective effects and improved memory retention in diabetic animals. Thus root extract of Withania Somnifera may have neuroprotective effects for the management of T2DM induced cognitive deficit.
Anti Inflammatory and Antioxidant Activity of Ziziphus Jujuba Extract
Authors: Singh Bhawana , Gautam Sandra , Dubey B K , Basedia Deepak Kumar
Published: January 2023

The antioxidant activity of the leaves and fruits of Ziziphus jujuba and contribution in some phytochemical characteristics was obtained. Phytochemical analysis was found that Ziziphus jujuba leaves and Fruits were loss on drying 0.85%, 0.65%, total ash values were 5.3%, 7.6% , Acid insoluble ash value were 2.9%, 4.4%, Water soluble ash value were 0.7%, 1.1% and Foaming index were 13ml, 12ml. Phytochemical screening was found that carbohydrate present in JFE and JFA, alkaloids were present in JLE, JLA and JFE, glycosides were present in JFA, flavonoids were present in all type of extracts, steroids were present in only JLE and protein and amino acids were present in JFE and JFA. JFE possessed higher antioxidant activity with IC50 value of < 300 µg/ml among all extracts for both methods and higher inhibition found in DPPH method 96.32% and in ABTS method  it is 98.68 %.  Aqueous extract of Ziziphus Jujuba fruit (JFA) was exhibited excellent anti-inflammatory activity against COX-1 & Cox-2 with IC50 value less than <0.2mg/ml.  Ethanolic extract of leaf (JLE) & Ethanolic extract of fruit (JFE) possessed moderate activity (< 0.3) against both COX-1 & Cox-2.  Aqueous extract of leaf (JLA) exhibited poor activity against both COX-1 & Cox-2. Overall conclusion of anti-inflammatory study of different extracts of Ziziphus Jujuba leaves and fruit were possessed anti inflammatory activity and inhibition was increased with concentration of samples increased.
Formulation of Roselle Flower Extract Gel (Hibiscus sabdariffa L) as a Disclosing Solution
Authors: Nurilawaty Vitri , Priharti Dwi , Sukmawati Ai Emalia , Sasongko Bimo Gigih , Tulandi Silvester Maximus , Purnama Tedi
Published: January 2023

Background: Plaque is a soft deposit attached to the teeth consisting of various types of microorganisms from saliva and food waste. Plaque cannot be seen because it is transparent, like the color of translucent white glass. The way to see plaque is to use a contrast material such as a dye (red/purple) in the form of a liquid or gel called a disclosing solution. It is usually found in gel and liquid form. But in use in humans there are many shortcomings because they are expensive, quite expensive and often contain harmful chemicals. One of the herbal plants that can be used as an alternative material as a disclosing solution is Rosella (Hibiscus sabdariffa L.) which can be used for its properties in the field of Prevention of Dental and Oral Diseases and has antibacterial and remineralizing effects. Methods: This research is an experimental study on the development of Rosella Flower Extract (Hibiscus sabdariffa L.) in the form of a gel in disclosing solution. The research was carried out from June to August 2021 at the Pharmacognosy Laboratory, Department of Pharmacy and Food Analysis, Health Polytechnic of Jakarta II and Dental Health Laboratory, Health Polytechnic of Jakarta I. Disclosing solution prepared from dried Rosella Flowers (Hibiscus sabdariffa L.) was obtained as much as 1000 grams. from the Research Institute for Spices and Medicinal Plants, Bogor. Hedonic testing was carried out on 34 students of the Department of Dental Health, Health Polytechnic of Jakarta I. Results: The disclosing solution preparation in the form of a gel from rosella flower extract had good organoleptic test results. The expected red color corresponding to the color of the disclosing solution is at a concentration of 70%. The average pH of the disclosing solution in the form of a gel was 4.95. The average dispersion of the gel preparation is 5.7. 5. The average adhesion of gel preparations at all concentrations is 1.44 seconds. The hedonic test was obtained that most of the respondents had a neutral opinion on all disclosing gel preparations. Conclusion: The preparation of Roselle Flower Extract Gel (Hibiscus sabdariffa L) can be used as an alternative disclosing solution
Imunomodulatory Effect of Red Tip Leaf’s (Syzygiummyrtifolium Walp.) Ethanol Extract on Male Rat
Authors: Sinulingga Rony Andreas Harka , Hasibuan Poppy Anjelisa Z , . Yuandani , . Rosidah , Dalimunthe Aminah
Published: January 2023

The pattern of modern life demands that everything must be done very fast and instant. The quality of the consumed food,  air pollution, lack of exercise and stress can cause the body’s endurance to decline continuously. The Red Tip (Syzigium myrtifolium Walp.) has been researched to have a  flavonoid compound that has benefits as an anti-inflammatory and have potentially as an immunomodulator. The purpose of this study is to prove the effect of immunomodulator on the activity of phagocytosis, the total number and the differential of leukosit, the antibody titer  value, and delayed type hypersensitivity response. Group treatment to test the clearance of carbon divided into 7 groups, each consisting of 5 male mice including the group of CMC-Na 0.5 %, Imboost ® dose 22.5 mg/ kgBB, the red tip leaf’s ethanol  extract with dose of 50, 100, 200, 400, and 800 mg/kg orraly distributed for 7 days, and on the 8th day the carbon suspension was given using i.v. The blood intake were done in certain times and then the absorbance was measured using UV-Vis spectrophotometer. The liver and spleen of the rats were taken and weighed. The treatment group for antibody titer was divided into 7 groups with each consisting of 5 male mice using the same treatment as above except positive control that has been used levamisole on 25 mg/kgBB dose that has been distributed orraly for 14 days. The non spesific immune respond utilizing carbon cleanses method by measuring the carbon elemination speed and total amount and leukocyte differential. The specific immune response testing using antibody titers was done based on glutination which was formed and the delayed type hypersensitivity testing based on the mice swollen foot. The research outcome shows that the distribution of the red tip leaf’s ethanol   extract with dose of 100, 200, 400, and 800 mg/kgBB is increasing the phagocytosis activity significantly compared to CMC-Na 0.5% (p < 0.05). The of the red tip leaf’s ethanol    extract is increasing the total of leukocytes and neutrophils of the segment. The distribution of the red tip leaf’s ethanol    extract with dose of 50, 100, 200, 400, and 800 mg/kgBB is increasing the formation of rat’s immune cell antibodies significantly compared to CMC-Na 0,5% (p < 0,05).This research prove that the red tip leaf’s ethanol    extract has an effect of imunostimulator againts the phagocytosis activity, the total sum and leukocytes differential along with antibody titer value and the delayed type hypersensitivity.
Prevalence and Evaluation of Complications in Valvular Heart Disease Patients In Tertiary Care Hospital
Authors: Rafeh Mariya Amtul , Mubeen Batool Arshiya , Polamuri Sri Praneeth , Koneru Anupama , Srinivas Nayak S. P
Published: January 2023

Background: One of the major outcomes of valvular heart disease have been chronic complications that in turn have led to the reduced quality of life of patients. These complications have indeed caused immense burden on the health care system and has led to increased mortality rate. Objective: To determine prevalence rate and to evaluate complications of valvular heart disease patients. Methods: This is a cross sectional-based study carried out in a single hospital in Hyderabad, India. The survey was carried out over a year in India. The source of data collection was through case sheets and lab reports. Results: Of the total 102 subjects, valvular diseases were more prevalent in the age group of 51-60 and females were found to be more affected than males. Complications were less or equal to no after the procedure of valve replacement was performed in patients with severe cases though some patients showed complications even after surgery, but were stable after a long time of monitoring. 1% of valve prolapse cases were seen and 3% deaths due to the disease. St.jude mechanical valve of different sizes, 19 EPR biological valve and aortic valve implants were majorly used for valve replacement procedure. Conclusion: The study concludes that valvular diseases are more prevalent in the age group 51-60, and females were more affected by valvular diseases than males. Hypertension and diabetes mellitus were found to be the major comorbidities in valvular heart disease patients.
Development and Validation Method for Simultaneous Investigation of Ambroxol Hydrochloride and N-Acetyl Cysteine In Bulk And Pharmaceutical Formulation By RP-HPLC.
Authors: Thote Lokesh , Dhabarde Disha , Baheti Jagdish , Borkar Shilpa , Bhusari Swati
Published: January 2023

A simple, precise and rapid reverse phase HPLC- SPD 20-Amethod has been developed and validated for the simultaneous investigation of Ambroxol Hydrochloride (AMB) and N-Acetyl Cysteine (NAC) in tablet dosage form. The mixture of (AMB) and (NAC) was separated on C18 5µm.column (4.5 µm × 25 cm). All separation were monitored with a SPD-20A UV-Vis detector on 210 – 400 nm wavelength at ambient temperature and flow rate of 1 ml/min. The mobile phase was phosphate buffer: acetonitrile (75:25) and pH 2.5 adjusted with dilute ortho-phosphoric acid. The retention time of AMB and NAC were found to be 8.4024 and 3.35088 respectivelythe resolution was 9.86346. The method was mean recoveries in the range of 100.4 to 100.15 for all components. The developed method can be use for the routine analysis of AMB and NAC in tablet dosage form.
PCR Technology and Its Importance In Covid-19 Pandemic
Authors: Maity Anupam , Chakraborty Krishnasis
Published: January 2023

Since the discovery of the PCR technology, its application in the various fields is increased gradually. Based on to this principle, many variations of the PCR have been established. Year by year, it is upgraded very much. It is established as a most common and accurate technique for the detection of the various diseases in the field of medicine. Now it is a ‘Gold standard’ for the detection of covid-19 also, which is much needed to contain the spread of the virus. Though various detection techniques are there for detection, but real time RT-PCR (variation of PCR) is most reliable. Viral detection is based on a simple principle of nucleic acid (viral) amplification. Various manufacturing companies are manufacturing the PCR instrument. Though the accuracy of the instruments are slightly differ to each other.
Pharmacognostic Characteristics, Chemistry, Biological Activity And Toxicity of Lolium Species
Authors: Al-Sa'idy Hussein Ali Hussein , Hamid Hussein Kamil
Published: January 2023

Around seven species of the genous lolium poisonous grasses belonging to the family Poaceae are mutually grown in corps field over the world. In Iraq the prennel ryegrass is locally called “rewatta”.The toxicity of these gasses are related to three chemically distinct alkaloids groups; the aminopyrrolizidine; lolines, indole-diterpenes (ergots, loliterms, and paxillines) as well as peramine alkaloids mostly concentrated in their seeds although indole-diterpene alkaloids loliterm B and paxilline biosynthesis requires endophytes symbiosis. The level of loline alkaloids enhances in both late summer-autumn of the year as well as in the infected dry plant materials up to 10 fold. However, paxilline and ergovaline are believed to be the precursor of the most toxic lolium species alkaloids, loliterm B, although, indole-diterpene alkaloids paxillines, loliterms and ergovaline are the actual indicators of Lolium species. In this review we summarize chemical characteristics, biological and toxicological influences as well as their interrelation of the plant of lolium genus. Central as well as peripheral biological/toxicological manifestations are summarized for both loline and indole-diterpene alkaloids. Finally, toxic influences of lolium alkaloids are function of their biological influences mostly exhibited via resembling molecular mechansims centrally as well as peripherallyare concluded.
Assessment of Regulatory requirements and filing procedure of Drug Master File for Brazil, Europe and South Africa
Authors: Patel Riya , Girase Kunal R. , Rao Venkateshwara T. , Patel Amit A. , Patel Ravish J.
Published: January 2023

A Drug Master File is a record that consists of detailed, correct data approximately an Active Pharmaceutical Ingredient (API) or Dosage Form of a Finished Product (FP). It is a classified document containing thorough, accurate, and up-to-date information regarding the active medicinal ingredient and medicament. A DMF is divided into two sections: (a) Open part (the Applicant's Part), which includes all of the details needed to determine the quality of a product. And (b) the Closed Part (Restricted Part). The Restricted Part (Closed Part) comprises openly undisclosed manufacturing method knowledge only given to authorized individuals. This compilation aims to offer a comparison of DMF regulatory necessities in addition to the exact data for the registration of lively pharmaceutical ingredients (API) for common drugs in various regulatory governments, including EUROPE (EDQM, EMA), BRAZIL (ANVISA), and SOUTH AFRICA (SAHPRA). This review will provide information on the differences and similarities in the DMF filing requirements in EUROPE, BRAZIL, and SOUTH AFRICA. The regulatory criteria for API registration vary by jurisdiction. Despite the existence and widespread adoption of an ICH-CTD standard format, there are also some limitations. There are a few particular requirements set provided to drug authorities along with the submission. The registration procedure is a regulatory undertaking that permits a person/organization/sponsor/innovator to get permission to participate in the regulation process for fetching marketing authorization/approval.
Comparison of Dissolution profile for Immediate-Release Dosage form for US and Europe
Authors: Kanojiya Shivam , Patel Neel , Patel Ravish J. , Patel Amit
Published: January 2023

Any oral medication product control strategy must include the creation of a dissolve method with appropriate specifications. In the creation of drug, dissolution testing is critical IV approach. In some cases, an IV dissolution test can be used instead of an in vivo dissolution test. As a result, regulatory agencies have formally acknowledged in vitro methods to determine the dissolution frequency of API from the solid oral form as a significant factor when manufacturing solid-oral-dosage forms. Dissolution tests have long been acknowledged as critical quality-control tools for ensuring batch-to-batch consistency. Following post-approval changes to pharmaceutical products, dissolution testing is also important in providing quality information of the product.
Regulatory perspective of Drug Repurposing: Methods, Regulatory pathways and Hurdles
Authors: Verma Sonal , Vaghela Khushboo , Zaveri Maitreyi
Published: January 2023

Drug repurposing is a phenomenon that aims at utilising an established and approved drug product or drug substance for an additional clinical indication apart from the one that it was intended for. The reprofiling of drug formulations creates an extensive arsenal of therapeutic options for drug products, thus making the practice a desirable and forthcoming procedure. There are several techniques and methods that have been adopted over the years to evaluate the various possibilities for the repurposing of drugs in search of a wider range of chemical therapeutics.

The repurposing of drug products has provided, over the course of time several different advantages to the pharmaceutical industry, and yet remains an uncomprehended and over-looked procedure. The following paper attempts to identify the different benefits that are to be gained from the repurposing of drug products along with the approaches that have been used for the same. Additionally, the paper also discusses the regulatory perspective of drug repurposing, emphasising on the incentives that are available for various pharmaceutical sponsors as well the hurdles that are to be faced during the repurposing of a drug product or drug substance.
Bioequivalence requirements of Pharmaceutical Products in US, Europe and Australia
Authors: Patel Nishi , Shah Jimesh , Patel Amit , Patel Ravish J.
Published: January 2023

In the last three decades, the notion of bioequivalence has gotten a lot of attention as it has been applied to new branded and generic medications. Generic medications must meet the same quality, efficacy, and safety requirements. Conventional products should be therapeutically equal to the reference product and compatible. The evolution of regulatory standards for bioequivalence in the United States, Europe, and Australia are examined in this paper. There is no international harmonization of regulatory requirements for bioequivalence, but the scope of bioequivalence and statistical analysis is partially harmonized; however, there are differences in applying single-dose trials and in vitro dissolution tests due to subject selection and reference product selection. The drug management system and drug regulating laws determine the pharmaceutical market's share. A bioequivalence study is one of the essential elements in the generic medicine approval process. The plasma time-concentration curve is frequently used in bioequivalence studies to determine absorption pace and absorption. The bioequivalence of the goods examined can be determined using the selected pharmacokinetic parameters and predefined acceptability thresholds. Recent advancements and information on crucial areas of bioequivalence study design and specification recommendations for each endpoint are included in this review.
AI models predicting Risk of Cardio Vascular Diseases - The Limitations, Challenges and Necessity for Regulatory Framework
Authors: Belidhe Vyshnavi , Maryam Suha , Siddala Srivani , Chinthamalla Divya , Garela Chandrakanth , Venkata Jithan Aukunuru , Jenugu Vidya Sagar
Published: January 2023

Artificial intelligence (AI) algorithms have changed the landscape of Cardio Vascular Disease (CVD) risk assessment and demonstrated a better performance mainly due to its ability to handle the input nonlinear variations. Further, it has the flexibility to add risk factors derived from medical imaging modalities using Computer Vision (CV). Most commonly used algorithms in CVD risk predications were classification and regression tress (CART).

Though most of the developed models have shown good accuracy but have not considered risks factors or dependent variables related to specific population which plays an integral role in predicting the risk of CVDs. This Include gender specific clinical risk factors (hormonal changes, bone density etc.), metrological, chronological data, exposure to environmental pollutants, race, genotype, hereditary, dietary intake, physical inactivity, psychological stress etc. Secondly the existing models have not included the weighing and grading of the risks, as all factors won’t contribute equally to the Cardiac Risk. Importantly predictive models can be readily used within the populations in which they were developed but practically they often give a less than satisfactory performance, when applied to another population because of the Inter genetic variations especially in CVDs.

India accounts for one-fifth of these deaths worldwide especially in younger population. The results of Global Burden of Disease study state age-standardized CVD death rate of 272 per 100000 populations in India, which is much higher than that of global average of 225. CVDs strike Indians a decade earlier than the western population. For Indians, particular causes of concern in CVD are early age of onset, rapid progression and high mortality rate. Indians are known to have the highest coronary artery disease (CAD) rates, and the conventional risk factors fail to explain this increased risk.

In Indian context, aggressive screening tests should begin at an early age and will be beneficial for early detection and treatment to reduce the mortality. Hence there is necessity to develop upgraded AI models specific to a subset of population (Indian, Caucasoid, Dravidian etc.) inclusive of the risk factors in that specific population. Secondly allotting weighing, grading of risk factors in the model will provide accurate cardiac risk prediction compared to other approaches.

The regulatory and policy landscape for AI is an emerging issue in jurisdictions globally, including in the European Union and in supra-national bodies like the IEEE, OECD and others. Since 2016, a wave of AI ethics guidelines has been published in order to maintain social control over the technology.
Clinical Trial Agreement – Eliminate legal problems when conducting clinical trials in Germany
Authors: Gerst Christoph , Geringer Christina , Voigt Thomas , Ahmed Raees
Published: January 2023

The possibilities of structuring clinical trial agreement are far reaching. Especially regarding the question, who the contract partner will be, an initial, also liability-related, positioning is possible; by either including or not including the respective examining physician in the agreement. The agreement has in large parts a clarifying function regarding the contractual obligations of both parties, as the AMG, the ICH-GCP guideline and various european regulations and directives stipulate a wide range of requirements for the performance of clinical trials. Inclusion in the agreement allows for a clear division of responsibilities and liability in the event of non-compliance with the requirements. It is also necessary that the sponsor is obligated to carry out quality assurance measures and the modalities of their implementation, including the remuneration of the time spent for this purpose.

A central question is also, who is entitled to the results of the clinical trial or to inventions based on them, whereby the ArbnErfG also must be taken into account. Whether there are at least rights of use for non-commercial purposes for the other party, should also be regulated. Also relevant is the agreement of confidentiality agreements and the answer to the question, when and to which extent publications on the results of the tests in question are permissible, in order to ensure an appropriate balance of the parties' interests.

In terms of data protection law, special attention must be paid to the question which party is the controller within the meaning of the GDPR - depending on the answer to this question, complicated and extensive regulations must be made. In addition to the regulation of the remuneration and its payment modalities, regulations regarding the liability, at least within the legal ramifications are possible and necessary. Conclusively – as always - general cancellation rights and other possibilities of terminating the agreement can be added.

The preceding explanations show how complex and comprehensive the aspects to be taken into account are. Numerous possibilities have been highlighted above, in order to provide an overview and to simplify the drafting, in hope that the contribution may aid as an orientation.
Oncology Drugs: Evolution, Comparative study of Global Drug Regulatory approval process and various measures to improve availability and accessibility
Authors: Sharma Shagun , Sharma Khushbu , Verma Pooja , Rahi Shivali , Rana Arpana
Published: January 2023

Cancer is the leading cause of death worldwide and is a well-known fact that it can be cured if detected and treated early. Cancer treatment has evolved from conventional therapies like vinca alkaloids, photodynamic and radiation therapy, chemotherapy to immunotherapy. Recent advances in tumour agnostic therapies based on cancer genetics and molecular features has led to a single drug treating different types of cancers. Next Generation sequencing (NGS) represents an effective way to gather large amount of genomic information about a cancer. The concept of precision medicine goes along with an understanding of the cancer genome as determined by NGS. Thus with an array of cancer diagnosis and treatment options the marketing approval process globally is challenging. This is mainly due to lack of harmonization of guidelines. This review evaluates the approval process of oncology drugs in US, EU and India.  Recent USFDA initiatives like Project Orbis involving multi country collaboration and real time oncology review while EU PRIME and WHO proposed reliance pathway are several global initiatives which accelerates assessment process.

New NDCT rules introduced in India in 2019 is one of the key step towards faster availability and accessibility of Cancer drugs in the country.

Countries with high resource settings like USA and EU have recognized this and have made several initiatives to provide early access to patients. USA has several pathways for speeding up the regulatory approval process for oncology drugs. India has recently came up with New Drugs and Clinical Trial rules, 2019 (NDCT rules 2019) which laid down the provisions of Provisions of Accelerated approval, Expedited review and Clinical trial waivers ensures faster availability and accessibility  of  cancer drugs in the country.

Although a lot of initiatives have already been taken in this direction still there is a strong need to harmonize the requirements globally for faster availability and accessibility of drug in the country for the much-needed patients.
Survey of the Jan Pariyojana Scheme in India and its impact on citizens during the previous decade
Authors: Kaul Evesh , Gupta Priyanka
Published: January 2023

It is a well-known fact that Branded medicines are sold at significantly higher prices in India. Making affordable, high-quality pharmaceuticals available on the market will help everyone, but mainly the underprivileged and destitute given the country's pervasive poverty. The Indian government has always been quite concerned about this. The Ministry of Chemicals and Fertilizers' Department of Pharmaceutical has periodically implemented a number of regulatory and financial initiatives to achieve this goal.

The "Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana" is a wonderful project started by the Indian government back in 2008 for the worthy purpose of providing high quality medications at accessible prices to all.

The Pariyojana involved selling inexpensive generic medications through upscale retailers called "Pradhan Mantri Bhartiya Jan Oshadhi Kendra" in different regions of the nation. On November 25, 2008, the first "Pradhan Mantri Bhartiya Jan Oshadhi Kendra" in Punjab's Amritsar city was inaugurated.

At first, it was planned that the "Pradhan Mantri Bhartiya Jan Oshadhi Pariyojana" would be implemented during the 11th Five-Year Plan period, beginning in 2008-2009, with the goal of establishing at least each Pradhan Mantri Bhartiya Jan Oshadhi Kendra in each of the firm's 630 regions, and then expanding to sub divisional levels as well as major town and village centers by 2012.

After garnering early support, the concept was planned to be self-sustaining and not rely on government subsidies or assistance. It was to be run on the basis of "No Profit, No Loss."
Comparisons of registration requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India
Authors: Patel Khushali , Patel Utsav , Vaghela Khushboo , Kanki Niranjan , Zaveri Maitreyi , Movaliya Vinit
Published: January 2023

"Nutraceuticals" are the combination of Nutrition and pharmaceutical. The term Nutraceutical was given by Dr. Stephen in 1989. A dietary supplement is a product taken by mouth that contains a dietary ingredient (Vitamins, Minerals, Herbs, Amino acids etc.) Numerous definitions and nomenclature for dietary supplements exist worldwide. In India Food Safety and Standards authority (FSSA), defines Nutraceuticals as "foods for special dietary uses or functional foods or health supplements". In Philippines Nutraceuticals are known as food supplement & dilatory supplement. In Sudan, Nutraceuticals are known as dietary supplement & health product .In Cambodia Nutraceuticals are known as health supplement product. Every country has their own guidelines, regulatory requirements which deal with regulatory registration procedures of Nutraceuticals. In order to enter the Indian Nutraceutical market, some of the very important areas of focus include product evaluation, actual product analysis, procuring licenses and developing India specific health and label claims.
A study of Regulatory aspects on Registration of Orphan Drugs in US and EU
Authors: S. Vasantha Mounika  , P. Ramya  , M.S.L. Divya  , S. Naga Swaroopa  , Raju K. Venkateswara , N.L. Prasanthi
Published: January 2023

The medicinal products used in the treatment, prevention, and diagnosis of rare disease like Myoclonus disease, Huntington's disease, Tourette syndrome are called as Orphan drugs, when it comes to defining rare disease and approving them as “Orphan designations.” The Criteria varies from country to country based on severity, prevalence of the disease and alternative therapies available.

In 1983, the US government brought the Orphan Drug Act to facilitate and encourage pharmaceutical company to develop orphan drugs without which they show reduced interest in the research and development of these drugs. The reason being their low market value and sales of orphan a drug is so miniscule that it will not enable them to even recover a fraction of the investment made in them.

After the inception of “Orphan Drugs” act 4500 orphan designations have been approved, 730 biologic drug products have been approved to treat 250 Orphan designations.

In the past decades, orphan designations have doubled in number when compared to its preceding decade but only 1/5th of the developed medications to treat them and received regulatory approval.
Analysis of emergency Drug Approval System in China and the United States under Public Health emergencies and its enlightenment to China
Authors: Chen Wei , Liang Yi
Published: January 2023

Objective: Public health emergencies, such as COVID-19, put forward a severe test to the response system of countries all over the world, including China. Especially under such conditions, the establishment and operation of the emergency drug approval system is particularly important. The purpose of this paper is to compare and analyze the emergency drug approval system between China and the United States, and learn from the experience of developed countries to improve China's drug review capability in response to public health emergencies.

This paper mainly analyzes the emergency drug approval system of China and the United States under public health emergencies through literature research and comparative analysis theory. Although there are four channels to accelerate the approval of drugs for listing in China, none of them can solve the problem of emergency drug use in the face of public health emergencies, and cannot become the policy basis for the use of unlisted drugs or drugs beyond the instructions.

Conclusion: On the basis of maintaining China's own institutional advantages and drawing on foreign experience, this paper puts forward relevant policy recommendations to improve China's emergency drug approval system in the event of public health emergencies.
KETIMPANGAN PENDAPATAN ANTAR KABUPATEN DAN DAN KEMISKINAN DI PROVINSI
Authors: Murtala Murtala
Published: January 2023

Badan Pusat Statistik (BPS, 2021) mencatat jumlah penduduk miskin di Aceh pada Maret 2021 sebanyak 834,24 ribu orang, meningkat 0,04 persen dibandingkan September 2020 sebanyak 833,91 ribu orang. Namun, angka kemiskinan di Aceh mengalami penurunan dari 10,43 persen pada September 2020 menjadi 10,33 persen pada Maret 2021. Secara rinci, tingkat kemiskinan di pedesaan Aceh menurun dari 17,96 persen pada September 2020 menjadi 17,78 persen pada Maret 2021. Sementara itu, kemiskinan perkotaan di Aceh akan meningkat dari 10,31 persen pada September 2020 menjadi 10,46 persen pada Maret 2021.Penelitian ini dilakukan di Provinsi Aceh pada 23 kabupaten/kota. Data yang digunakan adalah data sekunder. Data sekunder adalah data yang bersumber dari publikasi di berbagai instansi pemerintah, antara lain Badan Pusat Statistik (BPS) Provinsi Aceh dan instansi terkait lainnya yang terkait dengan penelitian ini. Metode analisis data yang digunakan adalah model deskriptif kualitatif dan juga menggunakan model Koefisien William Son.Dari 23 kabupaten/kota di Provinsi Aceh, pendapatan per kapita yang paling merata dengan koefisien Williamson di bawah 0,05 adalah Aceh Singkil, Aceh Selatan, Sabang, Langsa, Subulussalam, Aceh Tamiang, Nagan Raya, Bener Meriah, Gayo Lues, Aceh Tengah, Kabupaten Aceh Barat, Aceh Besar, Bireuen dan Aceh Barat Daya. Ternyata ketimpangan pendapatan yang terjadi akan meningkatkan tingkat kemiskinan yang terjadi di Provinsi Aceh.Diharapkan pemerintah daerah dapat mengidentifikasi semua potensi sumber daya yang terdapat di daerahnya masing-masing dan kemudian menggalinya untuk meningkatkan Produk Domestik Regional Bruto, sehingga pada gilirannya dapat meningkatkan pendapatan per kapita sendiri dan akan mengurangi jumlah penduduk miskin
Nilai Akhlak Qur’ani dalam Kehidupan Masyarakat
Authors: Hakim Lukman , Fadhli Muhajirul , Mulmustari Mulmustari
Published: January 2023

The rapid development of technology has had a negative influence on morals in society, religious values which were initially very strong in society have experienced a drastic decline. From these problems, this paper will look at the formulation of Qur'anic moral values in people's lives. As a literature review, data was collected through document review with descriptive analysis. The results of the study show that the concept of Qur'anic morality encourages humans to have the morals described by the texts of the Qur'an. Because a concept is meaningless if it is only in the form of theoretical value. Methods that can be used in applying morals in life are exemplary methods, habituation and coaching methods. The moral values that can be felt by humans are balance, social harmony and harmony in life. This value can be felt when the application of the morals taught by the Qur'an is practiced in everyday life.Abstrak: Perkembangan teknologi yang begitu cepat telah memberi pengaruh negatif terhadap akhlak dalam masyarakat, nilai-nilai agama yang awalnya sangat kental hidup dalam masyarakat telah mengalami penurunan yang drastis. Dari persoalan tersebut, tulisan ini akan melihat perumusan nilai akhlak qur’ani dalam kehidupan masyarakat. Sebagai kajian yang bersifat kepustakaan, data dikumpulkan melalui telaah dokumen dengan analisis deskriptif. Hasil penelitian menunjukkan bahwa konsep akhlak qur’ani menganjurkan manusia memiliki akhlak yang dijelaskan oleh nash-nash Al-Qur’an. Karena sebuah konsep tidak bermakna apabila hanya dalam bentuk nilai teoritis. Metode yang dapat digunakan dalam menerapkan akhlak dalam kehidupan yaitu metode keteladanan, pembiasaan dan metode pembinaan. Adapun nilai akhlak yang dapat dirasakan oleh manusia adalah adanya keseimbangan, harmoni sosial dan keselarasan dalam kehidupan. Nilai tersebut dapat dirasakan apabila penerapan akhlak yang telah diajarkan oleh Al-Qur’an dipraktikkan dalam kehidupan sehari-hari.
Hubungan Ilmu dan Amal dalam Al-Qur’an
Authors: Nurlaila Nurlaila , Almuzammil Mudaris
Published: January 2023

Knowledge and its practice are two things that are very related; the practice of something should be based on knowledge so that what is done is in accordance with the teachings of religion. Ironically, some people, without knowledge, dare to do something with full confidence. This paper aims to discuss the relationship between knowledge and charity in the Qur'an and how to apply these two concepts in life. This research was library research; the data was collected using the Mawdu'i method. The study showed that the verses that explain knowledge first and then practice are found in Surah Muhammad, verse 19. Practice without knowledge in Surah al-Isra verse 36. knowledge must be accompanied by practice in Surah al-Baqarah verse 44 and Surah al-Saf verses 2 and 3. Applying the concepts of knowledge and practices in life can be started by studying religion first. So that you are not wrong in doing charity, you should follow the Prophet as a good example in practice.Abstrak: Ilmu dan amal merupakan dua hal yang sangat berkaitan, pengamalan terhadap sesuatu hendaknya didasarkan pada pengetahuan, sehingga apa yang dilakukan sesuai dengan ajaran dalam agama. Ironisnya, sebagian masyarakat, tanpa didasari pada pengetahuan, berani mengamalkan sesuatu dengan penuh keyakinan. Tulisan ini berupaya mengkaji hubungan antara ilmu dan amal dalam al-Qur’an serta bagaimana mengaplikasikan kedua konsep tersebut dalam kehidupan. Penelitian ini merupakan penelitian kepustakaan, data dianalisis menggunakan metode mawdu’i. Hasil penelitian menunjukkan bahwa ayat-ayat yang menjelaskan berilmu dahulu baru beramal terdapat pada surah Muhammad ayat 19. Beramal tanpa didasari dengan ilmu pada surah al-Isra’ ayat 36. Berilmu harus disertai dengan amalan pada surah al-Baqarah ayat 44, surah al-Saf ayat 2 dan 3. Mengaplikasikan konsep ilmu dan amal dalam kehidupan dapat diawali dengan mempelajari ilmu agama terlebih dahulu, agar tidak salah dalam beramal hendaknya mengikuti Rasulullah sebagai teladan yang baik dalam beramal.
Seni Baca Al-Qur’an secara Halaqah di Taman Pendidikan Al-Qur’an (TPQ) Nurul Mubtadi Gampong Simpang Peut Nagan Raya
Authors: Djuned Muslim , Abubakar Syukran , Merryana Nya`k
Published: January 2023

TPQ Nurul Mubtadi is one of the recitation places in Simpang Peut Village that teaches the art of reading the Al-Qur'an with a different method from other recitation places, where the recitation is carried out in halaqah form. This paper aims to discuss the level of success in the art of reading the Quran with halaqah and the methods applied to TPQ Nurul Mubtadi in reading the Quran. This was a qualitative study with data collection techniques including observation, interviews, and documentation. This study showed that the halaqah reading of the Koran in the art of reading the Koran for TPQ Nurul Mubtadi students had a very good effect because the students were required to master the science of recitation and the basic rhythms such as bayyati syuri, bayyati husaini, hijaz, nahwand dan rast . Classes are held on Wednesday and Thursday nights. The method applied in the Art of Reading the Qur'an is the talaqqi or musyafahah method.Abstrak: Taman Pendidikan al-Qur’an (TPQ) Nurul Mubtadi merupakan salah satu tempat pengajian di Gampong Simpang Peut yang mengajarkan seni baca Al-Qur’an dengan metode yang berbeda dari tempat pengajian lain, di mana pengajian seni baca AL-Qur’an dilakukan dalam bentuk halaqah. Dari permasalahan tersebut, tulisan ini akan membahas sejauh mana tingkat kehasilan seni baca Al-Qur’an secara halaqah serta metode yang diterapkan pada TPQ Nurul Mubtadi dalam pembacaan Al-Qur’an. Kajian ini merupakan kajian lapangan yang bersifat kualitatif. Data dikumpulkan melalui observasi, wawancara dan dokumentasi. Hasil penelitian menunjukkan bahwa pembacaan Al-Qur’an secara halaqah menggunakan seni baca Al-Qur’an pada santri TPQ Nurul Mubtadi sangat baik, peserta diwajibkan menguasai ilmu tajwid serta menguasai irama dasar seperti bayyati syuri, bayyati husaini, hijaz, nahwand dan rast. Pembelajaran dilaksanakan pada malam rabu dan kamis. Adapun metode yang diterapkan dalam Seni Baca Al-Qur’an adalah metode talaqqi atau musyafahah.
Karakteristik Masyarakat Islam Perspektif Al-Qur’an: Analisis QS. Ali-Imran Ayat 110
Authors: Fikry Husnul , W Sulaiman , Nuraini Nuraini , Mardhiah Ainun
Published: January 2023

The Qur’an as a guide has not been understood by some Muslim communities. Therefore, bad behavior still occurs, so the character of Islamic society has a bad impact. This discussion is to reveal "How are the characteristics of Islamic society from the perspective of the Qur'an". Method of discussion uses a thematic interpretation approach, collecting Qur'anic verses related to "characteristics of Islamic society." The data is processed based on two sources. (a) The primary source is in the form of Qur'anic verses related to "characteristics of Islamic society" and its interpretation; (b) secondary sources that are closely related to the main material in the discussion, such as books, such as Qurani Society and Tracing the Concept of Ideal Society in the Qur'an, as well as several books of interpretation, such as the book of interpretation of Al-Mishbah, Al-Azhar, etc. The results show that the Islamic community is made up of people who have the best character, provided that they are carrying out the rules of Allah SWT. There are three reasons why Muslims are the best people. 1. Muslims are believers. 2. Muslims are people who always advocate for goodness (amar ma'rûf), and 3. Muslims are people who do not allow crimes that can damage society (nahi mungkar).Abstrak: Al-Qur’an sebagai petunjuk belum dipahami oleh sebagian masyarakat muslim. Oleh karena itu, perilaku tidak baik masih saja terjadi, sehingga karakter masyarakat Islam berdampak buruk. Pembahasan ini untuk mengungkapkan; “Bagaimana Karakteristik Masyarakat Islam Perspektif Al-Qur’an". Metode pembahasan ini menggunakan pendekatan tafsir tematik, mengumpulkan ayat-ayat Alquran yang berkaitan dengan “karakteristik masyarakat Islam”. Data diolah berdasarkan dua sumber. (a) Sumber primer berupa ayat-ayat Alquran yang berkaitan dengan “karakteristik masyarakat Islam” dan penafsirannya, (b) Sumber sekunder yang erat kaitannya dengan bahan pokok dalam pembahasan, seperti buku; Qurani Society, Menelusuri Konsep Masyarakat Ideal dalam Alquran, serta beberapa kitab tafsir, seperti kitab tafsir Al-Mishbah, Al-Azhar, dan lain-lain. Hasil menunjukkan bahwa masyarakat Islam perspektif Alquran adalah umat yang memiliki karakter terbaik dengan syarat selagi umat Islam tersebut menjalankan aturan Allah SWT. Ada tiga alasan bahwa umat Islam adalah umat terbaik. 1. Umat Islam adalah umat yang beriman kepada Allah SWT. 2. Umat Islam adalah umat yang senantiasa menganjurkan kepada kebaikan “amar ma'rûf” dan 3. Umat Islam adalah umat yang tidak membiarkan kejahatan yang dapat merusak masyarakat “nahi mungkar.”