bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pegylation: Camouflage of Proteins, Cells, and Nanoparticles Against Recognition by the Body's Defense Mechanism
Authors: Cho Yong Woo , Park Jae Hyung , Park Ji Sun , Park Kinam 
Published: March 2010

AbstractPolyethylene glycol (PEG) is becoming a standard polymer for chemical modification of proteins and peptides to enhance their pharmaceutical properties. PEGylation is increasingly used for attaching PEG to various objects, such as peptides, proteins, cells and other biologically active materials. This article focuses on pegylation of proteins, which has brought numerous clinically useful products and triggered explosive interest in polymers in the field of pharmaceutical biotechnology.
Unexpected Benefits of a Formulation: Case Study with Erythropoetin
Authors: Keast David 
Published: March 2010

AbstractRecombinant human erythropoietin (rHuEPO) is a purified glycoprotein produced by recombinant DNA technology. It has the capability for the treatment of the anemia associated with chronic renal failure and prematurity. This article provides an overview of human recombinant erythropoietin which significantly improves the quality of life for patients on real dialysis by managing the concomitant anemia.
Capillary Separation Techniques
Authors: Na Dong Hee , Lee Kang Choon 
Published: March 2010

AbstractCapillary electrophoresis (CE) is being extensively applied for characterization of biotechnology derived products like peptides and proteins. Recently, the role of CE in the strategy of protein analysis increases, with an emphasis on multidimensional separation and the combination of mass spectrometric techniques. This article gives emphasis on the fundamental principles of CE and its application to the separation and characterization of peptides and proteins.
Analytical Considerations for Immunoassays for Macromolecules
Authors: Kelley Marian , DeSilva Binodh 
Published: March 2010

Abstract
Current guidance documents for the assessment of analytes and their metabolites in biological fluids are focused on the quantification of small molecules using chromatographic and mass spectrometry platforms. These guidelines come short in immunoassays that confer practicality and specificity associated with antibody binding of analytes from biological fluids. This article focuses on analytical considerations of immunoassays for macromolecules, such as assessment parameters, partial validation, method transfer, cross‐validation, total error, and documentation.
Chromatography‐Based Separation of Proteins, Peptides, and Amino Acids
Authors: Moebius Jan , Swart Remco , Sickmann Albert 
Published: March 2010

AbstractSince the first commercial introduction of high performance liquid chromatography (HPLC), it has gained wide popularity, resulting in a phenomenal increase of successful applications described in literature. HPLC is a highly efficacious method in peptide and protein analysis especially for the preparation of samples for further analysis by electrospray mass spectrometry. This article focuses on the analytical aspects of liquid chromatography of biomolecules from amino acids to proteins.
Bioanalytical Method Validation for Macromolecules
Authors: Scriba Gerhard K. E. 
Published: March 2010

Abstract
Analytical methods employed for the quantitative determination of drug substances and their metabolites in biological media play a significant role in the evaluation and interpretation of pharmacokinetic data. Small, “conventional” drug molecules are preferentially analyzed by chromatographic techniques and most emphasis has been on the validation of bioanalytical methods for such molecules. This article focuses on various validation issues associated with macromolecule bioanalysis and guidelines issued by regulatory authorities for bioanalytical method validation.
Microarrays in Drug Discovery and Development
Authors: Kumble Krishnanand D. , Kumble Sarita 
Published: March 2010

AbstractMicroarrays are grids of biomolecules in which each element of the grid performs a specific assay such as identification of a specific binding molecule or measuring a particular enzymatic activity. The potential of microarrays to facilitate global analysis of genes and gene products has led to its adoption in nearly every area of biological science—from basic research to clinical diagnostics. This article provides a technical overview of microarrays including information on array formats, production, and use of microarrays for interrogating various molecular species such as DNA, RNA, and proteins.
Proteins: Hormones, Enzymes, and Monoclonal Antibodies—Background
Authors: Materi Wayne , Gombos Zoltan , Wishart David S. 
Published: March 2010

AbstractThe human body is the collection of our own, endogenously produced enzymes, hormones, and antibodies that are responsible for maintaining homeostasis, stabilizing wounds, fighting infections, neutralizing toxins, keeping cancerous cells in check, and generally keeping us alive. Most of today's protein pharmaceuticals fall into 5 general classes, including hormones, vaccines, antibiotics, antibodies, and enzymes. This article describes the general features of pharmaceutically important hormones, antibodies, and enzymes.
Development and Characterization of High‐Affinity Anti‐TopotecanIgGand Fab Fragments
Authors: Chen Jin , Balthasar Joseph P. 
Published: March 2010

AbstractAnti‐drug antibodies are increasingly being used within an inverse targeting strategy to increase the pharmacokinetic and therapeutic selectivity of intraperitoneal (i.p.) chemotherapy. The anti‐topotecan (TPT) antibodies have demonstrated high affinity and sufficient purity for use in evaluating their use in “inverse targeting” strategies to optimize TPT i.p. chemotherapy. This article describes the development of hybridomas secreting monoclonal antibodies against TPT, and the production, purification, characterization, and pharmacokinetics of an anti‐TPT monoclonal antibody and of monoclonal anti‐TPT Fab fragments.
Recombinant Antibodies for Pathogen Detection and Immunotherapy
Authors: Pokorny Nicholas J. , Boulter‐Bitzer Jeanine I. , Hall J. Chris , Trevors Jack T. , Lee Hung 
Published: March 2010

AbstractIn recent years, there has been increasing interest in developing recombinant antibodies (rAb) for immunodiagnostics and immunotherapeutical applications. Recombinant DNA technology and antibody engineering have increased the available avenues of antibody use, particularly in the application of immunotherapies. This chapter focuses on new developments in rAb with a particular emphasis in pathogen detection and immunotherapy.
The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted
In Situ
Radiotherapy of Malignancies
Authors: Reilly Raymond M. 
Published: March 2010

Abstract
Radiolabeled monoclonal antibodies (mAbs) and peptides offer the opportunity for molecular imaging of tumors in order to probe their phenotypic properties. Various strategies are being used for labeling these biomolecules with single gamma‐photon‐emitters or positron‐emitters for single‐photon emission computerized tomography (SPECT) and positron‐emission tomography (PET) imaging, respectively. This article focuses on the radiopharmaceutical science that provides the foundation for these biomolecules, mAbs and peptides, for targeting radionuclides to tumors.
Gene Therapy—Basic Principles and the Road from Bench to Bedside
Authors: Rubanyi Gabor M. 
Published: March 2010

AbstractHuman gene therapy (HGT) is defined as the transfer of nucleic acids to somatic cells of a patient, which results in a therapeutic effect by correcting genetic defects, overexpressing proteins, or inhibiting the production of “harmful” proteins. In most applications, gene therapy represents a new, innovative drug delivery system making use of the technical and scientific advances of the last two decades in microbiology, virology, organic chemistry, molecular biology, biochemistry, cell biology, genetics, genomics, and genetic engineering. This article focuses on basic principles, development, and applications of gene therapy.
Formulations and Delivery Limitations of Nucleic‐Acid‐Based Therapies
Authors: Segura Tatiana 
Published: March 2010

AbstractGene delivery has expanded to include the delivery of small interfering RNA (siRNA) and oligonucleotides (ON), which can be used to decrease or downregulate the expression of a target protein. An effective gene delivery system can protect the nucleic acid from degradation, target the appropriate cell population, be efficiently internalized by the cell, avoid degradative pathways, and ultimately localize to the nucleus (DNA) or cytosol. This article focuses on systemic injection formulations, direct injection formulations, matrix‐based delivery, and limitations of nonviral nucleic acid delivery.
RNA
Interference: The Next Gene‐Targeted Medicine
Authors: Oleinikov Andrew V. , Gray Matthew D. 
Published: March 2010

Abstract
The newest laboratory method for modulating gene expression, RNA interference (RNAi), has gained rapid interest throughout the world of molecular research, and is being actively pursued as the next “gene‐targeted medicine.” RNAi is a process in which double‐stranded RNA (dsRNA) directs the specific degradation of a corresponding target mRNA. This article describes the main ideas, approaches, and technological directions that may guide the medical researcher interested in using RNAi methodologies to identify and develop new drug candidates.
Delivery Systems For Peptides/Oligonucleotides And Lipophilic Nucleoside Analogs
Authors: Schwendener R.A. , Schott Herbert 
Published: March 2010

AbstractDrug delivery systems (DDS) are developed for drugs with nonideal properties, such as poor solubility, tissue damage, and loss of drug activity after administration. The formulation of pharmacologically active drug molecules in DDS can improve or abolish toxic side effects and suboptimal therapeutic effects. This article focuses on DDSs for the delivery of peptides, DNA, plasmids, oligodeoxynucleotides, siRNA, and lipophilic nucleoside derivatives.
Production and Purification of Adenovirus Vectors for Gene Therapy
Authors: Prazeres D. M. F. , Santos J. A. L. 
Published: March 2010

AbstractGene therapy is a simple and attractive process which consists of the introduction of one or more functional genes in a human or non‐human receptor. Most recombinant viral vectors used in gene therapy clinical trials belong to adenovirus, retrovirus/lentivirus, pox/vaccinia virus, and adeno‐associated virus. This article focuses on adenovirus vector for gene therapy.
Assessing Gene Therapy By Molecular Imaging
Authors: Delépine Pascal , Férec Claude 
Published: March 2010

Abstract
Gene therapy consists of over expressing a functional gene, replacing a mutated gene or expressing an exogenous gene with the aim of correcting a malfunction, inducing an immune response or stimulating angiogenesis. Molecular imaging approaches can be used to observe, understand and document all phenomena involved in gene transfer. This article focuses on various imaging methods for gene therapy, including positron emission tomography (PET), single‐photon emission computed tomography (SPECT), bioluminescence, magnetic resonance imaging (MRI), and gamma imaging.
Comparability Studies for Later‐Generation Products—Plant‐Made Pharmaceuticals
Authors: Stewart Patrick A. 
Published: March 2010

Abstract
Plant Made Pharmaceuticals (PMPs) use genetically engineered plants to express substances that may be used to treat and cure diseases such as cancer, Alzheimer's disease, diabetes, HIV, heart disease. The boundary technology nature of PMPs places it firmly into limbo in terms of social acceptability and, ultimately, economic viability. This article explores PMPs and their potential with an eye toward public response and policy actions.
Biosimilars
Authors: Schellekens H. , Jiskoot W. , Crommelin D.J.A. 
Published: March 2010

Abstract
A biosimilar is defined as any therapeutic protein by its own manufacturing process that may influence the characteristics of the product itself. The producers of biosimilars therefore need to demonstrate consistency and robustness of their production process. This article focuses on main elements and guidelines for producing biosimilars.
An Overview of Metabonomics Techniques and Applications
Authors: Lindon John C. 
Published: March 2010

AbstractMetabonomics is the comprehensive and simultaneous systematic profiling of metabolite levels and their temporal changes in whole organisms. The main analytical techniques employed for metabonomic studies are based on nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS). This article describes types of samples, applications, and technologies used in metabonomics.
Radiopharmaceutical Manufacturing
Authors: Farstad Brit S. , Peñuelas Iván 
Published: March 2010

Abstract
Radiopharmacy is a patient‐oriented science that includes the scientific knowledge and professional judgment required to improve and promote health through assurance of the safe and efficacious use of radiopharmaceuticals. Radiopharmacy encompasses studies related to the pharmaceutical, chemical, physical, biochemical, and biological aspects of radiopharmaceuticals. This article focuses on the design, preparation, and quality control of radiopharmaceuticals, radiopharmaceutical chemistry and issues related to the management, selection, storage, dispensing, and proper use of radiopharmaceuticals.
Packaging and Labeling
Authors: Santoro Maria Inês Rocha Miritello , Singh Anil Kumar 
Published: March 2010

AbstractThe role of packaging and labeling in the pharmaceutical industry has grown substantially over the past decade. The packaging of a pharmaceutical product fulfils a variety of roles, such as product presentation, identification, convenience, and protection until administration or use. This article discusses the importance of the packaging and labeling of pharmaceutical preparations.
Clean‐Facility Design, Construction, and Maintenance Issues
Authors: Schneider Raymond K. 
Published: March 2010

Abstract
Successful pharmaceutical manufacturing plant projects incorporate practices that promote flow of the construction process toward completion on time and within budget. Engineering the clean room in accordance with recognized industry practice would produce construction documents that facilitate clear procurement and construction planning as well as a focused, efficient, construction effort. This article focuses on design, construction, and maintenance issues associated with clean‐room construction projects.
Solid Dosage Forms
Authors: Conway Barbara R. 
Published: March 2010

AbstractDrug substances are most frequently administered as solid dosage formulations, mainly by the oral route. Tablets and capsules are the most frequently used solid dosage forms and are unit dosage forms, comprising a mixture of ingredients presented in a single rigid entity. This article describes the characteristics and applications of different types of solid dosage forms, including, tablets, lozenges, and chewing gums.
Semisolid Dosages: Ointments, Creams, and Gels
Authors: Mahalingam Ravichandran , Li Xiaoling , Jasti Bhaskara R. 
Published: March 2010

Abstract
Semisolid dosage forms are traditionally used for treating topical ailments. Various categories of drugs such as antibacterials, antifungals, and antivirals are incorporated into these products, which show their activity on the surface layers of tissues or penetrate into internal layers to reach the site of action. This article focuses on the formulation, evaluation, and regulatory features of ointments, creams, and gels.
Liquid Dosage Forms
Authors: Rubio‐Bonilla Maria V. , Londono Roberto , Rubio Arcesio 
Published: March 2010

Abstract
Liquid dosage forms are designed to provide the maximum therapeutic response in a target population with difficulty swallowing tablets and capsules and/or to produce rapid therapeutic effects. Commercial liquid dosage forms reach large‐scale production after being preformulated at the laboratory level followed by formulation at the small scale and then at the pilot plant scale. This article focuses on different types of liquid dosage forms and critical aspects of liquids manufacturing process.
Liposomes and Drug Delivery
Authors: Antimisiaris Sophia G. , Kallinteri Paraskevi , Fatouros Dimitrios G. 
Published: March 2010

AbstractLiposomes are vesicles in which an aqueous volume is entirely surrounded by a phospholipid membrane and their size can range between 30 and 50 nm up to several micrometers. Liposomes serve as a drug delivery system because of their versatile structure and because they are nontoxic, nonimmunogenic, and fully biodegradable. This chapter focuses on basic characteristics and applications of liposomes, their fate after in vivo administration by different routes, and other possible routes for in vivo administration of liposomes.
Biodegradable Nanoparticles
Authors: Chakravarthi Sudhir S. , Robinson Dennis H. 
Published: March 2010

AbstractBiodegradable nanoparticles are a very active area of research in drug delivery, imaging, and diagnostics. The use of nanoparticles in drug delivery and nanomedicine necessitate use of biocompatible and biodegradable polymeric carriers for parenteral administration. This article focuses on the application of nanotechnology to deliver therapeutic or diagnostic agents using biodegradable polymeric nanoparticles for systemic, localized, or targeted delivery.
RecombinantSaccharomyces Cerevisiaeas New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation
Authors: Blanquet Stéphanie , Alric Monique 
Published: March 2010

AbstractThe development of recombinant deoxyribonucleic acid (DNA) technology has allowed the emergence of novel applications such as drug production directly in the human digestive environment (“in situ”) by ingested living recombinant microorganisms. Genetically engineered microorganisms offer several advantages over classical dosage forms, such as protection of active compounds and regulation of gene expression. This article focuses on the concept and applications of biodrug, scientific feasibility of biodrug concept using yeast as vector, and oral formulation of recombinant yeasts.
Aerosol Drug Delivery
Authors: Hindle Michael 
Published: March 2010

AbstractAerosol drug delivery to the lungs has long been the route of choice for the treatment of respiratory diseases, including asthma and chronic obstructive airway disease. Metered dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulizers have been employed to successfully deliver a wide range of pharmaceuticals principally to the lungs for local action. This article focuses on aerosol drug delivery devices, their development, and future prospects for pulmonary administration.
Ocular Drug Delivery
Authors: Rupenthal Ilva D. , Alany Raid G. 
Published: March 2010

AbstractDue to the accessibility of the eye surface, topical administration of ophthalmic medications is the most common method for treating conditions affecting the exterior eye surface. Various ocular delivery systems, such a ointments, suspensions, micro‐ and nanocarriers, and liposomes, have been investigated during the past two decades. This article focuses on the topical application of drugs to the surface of the eye and discusses the most recent formulation approaches in this area.
Microemulsions as Drug Delivery Systems
Authors: Alany Raid G. , Wen Jingyuan 
Published: March 2010

Abstract
Microemulsions (ME) represent an exciting opportunity for pharmaceutical formulators and drug delivery scientists. They can accommodate drugs of different physicochemical properties and protect those that are labile. This article focuses on the historical background, structure, formation, and pharmaceutical formulation of microemlsions, their application as drug delivery systems, and techniques used to characterize ME.
Transdermal Drug Delivery
Authors: Asbill C. Scott , Bumgarner Gary W. 
Published: March 2010

AbstractDuring the last decade there has been an explosion of drug candidates in clinical trials and a high number of dosage forms approved by the U.S. FDA that utilize the transdermal route of drug delivery. The interest in transdermals can be attributed to the advantages of maintaining steady‐state drug concentrations and bypassing first‐pass metabolism, and mimicking an intravenous (IV) infusion. This article focuses on drug candidates for transdermal drug delivery, transdermal patch design, commercially available patches, and various approaches to transdermal delivery.
Vaginal Drug Delivery
Authors: das Neves José , Amaral Maria Helena , Bahia Maria Fernanda 
Published: March 2010

AbstractThe vagina has been used for a long time as a route for drug administration. Vaginal drug delivery has seen recent advances that make it very promising, in particular therapeutic fields such as the prevention of human immunodeficiency virus (HIV) and other sexually transmitted infections, and contraception. This article discusses the main features of vaginal anatomy, physiology, and histology related to drug delivery as well as vaginal drug delivery systems and their evaluation, current usage of the vagina as a route of drug administration, and promising strategies in this field.
Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powders and Tablet Characterization
Authors: Lee Beom‐Jin 
Published: March 2010

AbstractTablet is a major category of solid dosage forms which are widely used worldwide. Based on preformulation studies, the optimal dosage forms are generally decided. This article focuses on general preformulation approaches for tablet production, physicochemical properties of drug and excipients, and types and functions of excipients used for tablet formulation and drug–excipient incompatibility.
Role of Preformulation in Development of Solid Dosage Forms
Authors: Perumal Omathanu P. , Podaralla Satheesh K. 
Published: March 2010

Abstract
Preformulation testing has a significant role in a drug discovery and development program, as it provides valuable feedback to the various discovery and development teams in enabling druggability during lead identification and optimization. In a generic setting, preformulation studies are mainly focused on developing a formulation that is bioequivalent to the innovator's product with the main objective of filing an abbreviated new drug application (ANDA). This article focuses on preformulation testing for oral solid dosage forms in a drug discovery setting.
Modeling and Informatics in Drug Design
Authors: Picker‐Freyer Katharina M 
Published: March 2010

AbstractTablet production systems can be defined as all machines which are able to produce tablets. Tablet production systems include tableting machines for production and research as well as tableting machine simulators, which are able to mimic the production processes of tableting machines to facilitate scale‐up. This article focuses on instrumentation of tablet production systems, tableting process, and the different techniques used for production and research of tablets.
Controlled Release of Drugs from Tablet Coatings
Authors: Altinkaya Sacide Alsoy 
Published: March 2010

Abstract
Controlled‐release technology for drug delivery applications is designed to target the drug to particular places or cells in the body and to control the duration and level of the drug in the body within a specified therapeutic window. Controlled‐release dosage forms provide sustained drug release and require less frequent drug loading than conventional forms. This article presents a review of manufacturing methods for the application of coating materials on tablets, characterization methods used to evaluate tablet coatings, techniques used for manufacturing asymmetric‐type membranes, and modeling approaches employed for optimization of the tablet coating formulations.