bluuebunny/crossref_metadata_2025_split huggingface dataset:
Anti‐Unicorn Principle: Appropriate Biomarkers Don't Need to be Rare or Hard to Find
Authors: Bleavins Michael R. , Rahbari Ramin 
Published: March 2010

AbstractThe emphasis on biomarkers as a new approach often has lead to expectations that the ideal biomarker must be novel and/or exotic. To answer the pertinent questions during drug development, teams often embark on the quest for the “unicorn” of biomarkers, sometimes resulting in the best and most practical test being overlooked as the search progresses for elusive methods. This article highlights examples of unicorn, horse, and mule biomarker approaches.
Biomarker Patent Strategies: Opportunities and Risks
Authors: Bott Cynthia M. , Baude Eric J. 
Published: March 2010

Abstract
The discovery and use of biomarkers presents opportunities and risks in the patent area. There are opportunities to patent biomarkers and methods of using biomarkers to further commercial ventures. There is also the risk of infringing third‐party patents when making or using certain biomarkers. This article focuses on various aspects of patenting biomarkers and identifying patent infringement risks.
IT
Supporting Biomarker‐Enabled Drug Development
Authors: Hehenberger Michael 
Published: March 2010

Abstract
It is believed that “biomarker‐enabled” drug development will lead to better and earlier decision making, paving the way toward targeted therapeutics combining “precision drugs” for stratified patient populations. Organizations who believe in biomarker‐enabled R & D are investing in tools and making the necessary organizational changes to implement the new concepts and associated processes. This article focuses on IT standards and architectures to support business strategies, including their implementation.
Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine
Authors: Webb Craig P. , Thompson John F. , Littman Bruce H. 
Published: March 2010

AbstractPersonalized medicine treatment strategies in cancer patients include diagnostics, targeted agents with well‐understood mechanisms of action, an understanding of the molecular pathways important in disease progression, and ways of rapidly assessing clinical success. This has especially been enabled by the power of new genomic, biomarker, and informatics technologies. This article focuses on the principles and the potential of personalized medicine in cancer, diabetes, and rheumatoid arthritis.
Ethics of Biomarkers: the Borders of Investigative Research, Informed Consent, and Patient Protection
Authors: Walmsley Heather , Burgess Michael , Brinkman Jacquelyn , Hegele Richard , Wilson‐McManus Janet , McManus Bruce 
Published: March 2010

AbstractIn recent years, there has been increased role of large biobanking projects within biomedical research. These projects reveal major public concerns with the social and ethical implications of these projects: for privacy, indigenous identity and self‐determination, ownership and control over body parts, and medical data for individuals and their families. This article focuses on the diversity of social and ethical issues surrounding biomarker‐related research and biobanks and its applications.
Pathodynamics: Improving Biomarker Selection by Getting More Information from Changes Over Time
Authors: Trost Donald C. 
Published: March 2010

Abstract
Pathodynamics refers to a quantitative approach to disease that includes how the biological system changes over time. In many ways it is analogous to thermodynamics in that it deals with the macroscopic, measurable phenotypic aspects of a biological system rather than the microscopic aspects such as those modeled in mathematical physiology. This article focuses on some approaches to thinking about pathodynamics.
Nanotechnology‐Based Biomarker Detection
Authors: Reineke Joshua 
Published: March 2010

AbstractRecent developments in genetics, proteomics, and nanotechnology have produced a large number of nanoparticle‐based biomarker detection systems, including nanoparticles, quantum dots, nanowires, nanocantilever, and nanoarrays. They are being used to address various challenges faced in the detection of biomarkers, such as multiplexing ability, specificity, and label‐free detection. This article focuses on nanoparticles and nanodevices currently being developed for the enhanced detection of biomarkers and reviews nanotoxicology issues and other challenges that nanotechnology will present to the biomarker field.
From Defining Bioinformatics and Pharmacogenomics to Developing Information‐Based Medicine and Pharmacotyping in Health Care
Authors: Vizirianakis Ioannis S. 
Published: March 2010

Abstract
Through sophisticated technological advances have achieved so far, genomic knowledge is being used to analyze complex diseases including cardiovascular diseases, asthma, cancer, and degenerated disorders. The use of automated DNA sequencing techniques and the application of DNA microarray (DNA chip) systems permit the rapid and reliable assessment of a large number of genes implicated in drug response and disease pathogenesis. This article focuses on the influence of bioinformatics and pharmacogenomics, information‐based medicine, and pharmacotyping in health care.
Toxicogenomics
Authors: Cunningham Mary Jane , Shah Mrinal 
Published: March 2010

AbstractToxicogenomics is the use of OMICS technologies to assess the safety of new chemical entities or other compounds used in diagnostics or therapeutics. OMICS technologies encompass genomics, proteomics, metabonomics, and pharmacogenomics. This article describes all OMICS methods and shows how they can be applied to studying toxicity in pharmaceutical development.
Preclinical Pharmacokinetics
Authors: Mager Donald E. , Ramanathan Murali 
Published: March 2010

AbstractThe preclinical pharmacokinetics of protein pharmaceuticals is distinctively different from small‐molecule drugs. Understanding the mechanisms and implications of in vivo disposition of macromolecules provides a means for investigating and designing novel drug candidates and delivery systems to optimize exposure‐response relationships or therapeutic efficacy. This article focuses on the different aspects of preclinical pharmacokinetics of protein pharmaceuticals.
Stability Assessment and Formulation Characterization
Authors: Chow Albert H.L. , Tong Henry H.Y. , Zheng Ying 
Published: March 2010

Abstract
A drug needs to be formulated in a safe, consistent, and stable dosage form with proven clinical efficacy before it can be approved for specific therapeutic indications by drug regulatory authorities. Depending on the modes of chemical degradation or physical denaturation, a wide variety of formulation excipients or additives, including buffers, antioxidants, sugars, and polysaccharides, can be used to preserve the structural integrity and biological activity of such vulnerable macromolecules. This article focuses on the stability problems of biopharmaceuticals and their assessment as well as the formulation approaches that can be used to circumvent these problems.
Formulation and Delivery Issues of Therapeutic Proteins
Authors: Balu‐Iyer Sathy V. , Miclea Razvan D. , Purohit Vivek S. 
Published: March 2010

Abstract
The protein therapeutics have unique handling and development requirements relative to the small organic molecule‐based drugs and pose exclusive challenges for the formulation scientist. The formulation and delivery issues of therapeutic proteins can contribute to difficulties in pharmaceutical development such as stability, immune toxicity, and pharmacodynamics‐related problems. This article focuses on formulation and delivery strategies of therapeutic proteins.
Immunogenicity of Therapeutic Proteins
Authors: Hermeling Suzanne , Crommelin Daan J.A. , Schellekens Huub , Jiskoot Wim 
Published: March 2010

AbstractThe introduction of recombinant DNA techniques has made possible to produce proteins on a large scale. These protein therapeutics are potentially immunogenic, inducing antibodies in patients after a certain period of treatment. This article gives an overview of the current knowledge about the immunogenicity of therapeutic proteins.
PlasmidDNAand MessengerRNAfor Therapy
Authors: Pascolo Steve 
Published: March 2010

AbstractRecent studies performed in animal models and humans show that injection of pDNA or mRNA is safe and can elicit the expected results. Because pDNA and stabilized mRNA have the natural capacity to activate the immune system through the triggering of TLR, pDNA‐ and mRNA‐based therapeutic utilizations are mostly tested in the field of vaccination. This article focuses on therapeutic applications of pDNA‐ and mRNA‐based approaches.
Case Studies—Development of Oligonucleotides
Authors: Chowdhury Ezharul Hoque , Akaike Toshihiro 
Published: March 2010

AbstractOligonucleotides have emerged as essential tools in pharmaceutical biotechnology by virtue of their small size, low‐cost chemical synthesis, and precise base pairing capability with other complementary sequences either in the transcriptome or in the genome. Oligonucleotides have the enormous potential to facilitate manufacturing of innovative molecular machinery with the help of molecular biology enzymes, for being used as genomics tools as well as therapeutic tools. This article focuses on various aspects of the development and use of oligonucleotides for therapeutic use.
Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics
Authors: Cao Heping , Lin Rui 
Published: March 2010

Abstract
Growth factors, such as cytokines, hormones and chemokines, refer to a large class of proteins capable of stimulating cellular proliferation and differentiation. Cytokines stimulate the humoral and cellular immune responses and activate phagocytic cells, where as chemokines induce directed chemotaxis in nearby responsive cells. This article addresses the issues related to the formulation, delivery, pharmacokinetics, and applications of growth factors, cytokines, and chemokines.
Overview of Stem and Artificial Cells
Authors: Soto‐Gutierrez Alejandro , Navarro‐Alvarez Nalu , David Rivas‐Carrillo Jorge , Kobayashi Naoya 
Published: March 2010

AbstractResearch on stem cells allows us to get the information about how an organism grows and develops from a single cell and how healthy normal cells replace damaged cells in adult organisms. Stem cells are capable of renewing themselves for long periods through cell division. This article reviews the nature and potential of embryonic stem cells.
Regulation of Small‐Molecule Drugs Versus Biologicals Versus Biotech Products
Authors: de los Angeles Cortés Castillo María , Di Fabio José Luis 
Published: March 2010

AbstractRegulation of drugs by health institutions and governments ensures public protection from unsafe products. In parallel with the development of drug regulations, biological regulations were developed to enforce safety concerns of drugs. This article focuses on regulation enforced in development of small molecules, biological (vaccines), and biotech products.
Intellectual Property and Biotechnology
Authors: Bubela Tania , Durell Karen Lynne 
Published: March 2010

Abstract
Intellectual property laws and regulations provide incentives for the production and distribution of new knowledge by establishing a mechanism for the creator of that knowledge to obtain compensation for the use of protected works. Patents are the most prevalent form of intellectual property right (IPR) sought for biotechnological innovation. This article provides an overview of intellectual property rights available for biotechnological innovation and regulations governing those rights.
Enhanced Proteomic Analysis by
HPLC
Prefractionation
Authors: Havugimana Pierre C. , Wong Peter , Emili Andrew 
Published: March 2010

Abstract
Proteomics is the global (genome‐wide) study of protein expression in a given living cell, tissue or organism. Multidimensional Protein Identification Technology (MudPIT), gel electrophoresis (GE) and high performance liquid chromatography (HPLC) are the widely employed approaches to survey protein levels in complex biological samples. This article describes an easily implemented, effective, and highly reproducible dual‐column HPLC prefractionation method that helps in improving routine proteomic analyses.
Regulatory Considerations in Approval of Follow‐On Protein Drug Products
Authors: Oliver Erin , Carl Stephen M. , Morris Kenneth R. , Becker Gerald W. , Knipp Gregory T. 
Published: March 2010

AbstractGiven the rising cost of health care and prescription medications in the U.S. and the expanding role of biologically derived products within the pharmaceutical landscape, multifaceted issues present a challenge to industry, regulators, and legislators alike. Recent FDA approvals provide insight into the technical requirements for approval of well‐characterized FOP products. This article provides an overview of the complex scientific, legal, and policy issues facing the development of biogenerics today.
From Pilot Plant to Manufacturing: Effect of Scale‐Up on Operation of Jacketed Reactors
Authors: Bequette B. Wayne 
Published: March 2010

Abstract
Temperature control for laboratory reactors is typically easy because of high heat transfer area – reactor volume ratios, which do not require large driving forces for heat transfer from the reactor to the jacket. Pilot‐and full‐scale reactors, however, often have a limited heat transfer capability. This article provides an overview of scale‐up considerations involved as one moves from bench‐scale reaction calorimetry to larger scale pilot plant and production reactors.
Controlled‐Release Dosage Forms
Authors: Anal Anil Kumar 
Published: March 2010

AbstractControlled drug delivery alters the pharmacokinetics and pharmacodynamics of pharmacologically active moieties using novel drug delivery systems or by modifying the molecular structure and/or physiological parameters inherent in a selected route of administration. Recent developments in drug delivery techniques has made it possible to control the rate of drug delivery to sustain the duration of therapeutic activity and/or target the delivery of drug to a specific organ or tissue. This article focuses on design and fabrication of controlled‐release oral dosage forms and the importance of different routes of administration.
Progress in Design of Biodegradable Polymer‐Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein
Authors: Tamilvanan Shunmugaperumal 
Published: March 2010

AbstractMicrospheres prepared from biodegradable polymers are widely recognized for controlled drug delivery following parenteral administration. Polyester polymers such as poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and their copolymer poly(lactic acid‐co‐glycolic acid) (PLGA) are used routinely for the preparation of injectable microspheres due to their biocompatibility, controlled biodegradability, and no toxicity of degradation products. This article focuses on investigations made progressively on the design of injectable peptide/protein‐loaded PLGA microspheres
Nasal Delivery of Peptide and Nonpeptide Drugs
Authors: Thomas Chandan , Ahsan Fakhrul 
Published: March 2010

AbstractIn recent decades, intranasal drug delivery has shown great promise in various fields of medical practice. Drug delivery via the nasal route offers a number of advantages, such as possibility of needle‐free treatment, rapid onset of action, and high bioavailability. This article describes delivery and absorption of drugs by the nasal route and appreciates the factors that may affect it.
Nasal Powder Drug Delivery
Authors: Filipović‐Grčić Jelena , Hafner Anita 
Published: March 2010

Abstract
Intranasal drug administration has been practiced since ancient times. Nasal dry powder formulations have been recognized as efficient nasal delivery systems offering numerous advantages over liquid formulations, such as avoidance of preservatives, improved formulation stability, and prolonged contact with the mucosa. This article focuses on the benefits associated with nasal dry powder formulations and microspheres as nasal drug delivery devices.
Tablet Design
Authors: Castellanos Gil Eddy , Caraballo Isidoro , Bataille Bernard 
Published: March 2010

AbstractThe compression of powders is a complex task due to the variability in particle size and shape, the unknown distribution of the particles in the die, their different ability to flow, and the forces needed to create bonds between them. In tablet design many factors have to be taken into account, such as the physicochemical properties of active compounds and excipients. This article provides a brief description of the main theoretical aspects of tablet design and formulation together with practical examples of tablet development and characterization using different techniques.
Tablet Compression
Authors: Santos Helton M. M. , Sousa João J. M. S. 
Published: March 2010

Abstract
The process of tablet compression involves the rearrangement of particles within the die cavity and initial elimination of voids. Since tablet compression relies on the ability of particulates to be compacted, the need to control the critical properties of the materials with respect to readiness or ability to compact is an important issue to the formulator. This article focuses on tablet compression process.
Oral Extended‐Release Formulations
Authors: Larsson Anette , Abrahmsén‐Alami Susanna , Juppo Anne 
Published: March 2010

Abstract
In order to achieve therapeutic effect, a drug needs to reach the right place in the body at the right time. For some drugs, this may be achieved by simple solutions or solid dosage forms with an instant drug release while, for others, one has to modify the drug release, such as modified‐release (MR) formulations and oral extended‐release (ER) formulations. This article focuses on formulation principles and manufacturing of the different forms of ER formulations, such as insoluble matrix tablets, membrane‐coated oral extended release, and hydrophilic matrix tablets.
Scale‐Up and Postapproval Changes (
SUPAC
) Regulations
Authors: Sharma Puneet , Ganta Srinivas , Garg Sanjay 
Published: March 2010

Abstract
Regulatory authorities in the U.S., Europe and Latin America require the pharmaceutical industries to follow guidelines on scale‐up and postapproval changes (SUPAC) to maintain the quality of the pharmaceutical products. Apart from these guidelines, there are other checkpoints, such as change control and validation exercises. This chapter describes the regulations imposed by different regulatory authorities.
GMP
‐Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells
Authors: Rohde Eva , Schallmoser Katharina , Bartmann Christina , Reinisch Andreas , Strunk Dirk 
Published: March 2010

Abstract
U.S. regulations demand that tests for potency shall consist of either in vitro or in vivo tests, or both. These tests should be designed specifically for each product so as to indicate its potency in a manner adequate to satisfy the interpretation of potency given by the definition in 21 CFR 600.3(s). This article demonstrates that rapid and standardized expansion of human mesenchymal stromal cells (MSCs) to achieve a reasonable cell dose is feasible within less than four weeks and replacing fetal bovine serum (FBS) with human platelet lysate (HPL) provides one strategy toward a safer cell‐based medicinal product (CBMP).
NationalGMPRegulations and Codes and InternationalGMPGuides and Guidelines: Correspondences and Differences
Authors: Närhi Marko , Nordström Katrina 
Published: March 2010

AbstractGood manufacturing practices (GMPs) is included as integral part of most of the countries' laws as part of legislation or separate guidelines to ensure safety, identity, and quality of drug products. Some international organizations and trade blocks also have issued their own international GMP guidelines to harmonize the requirements for drug. This article focuses on the U.S. and international GMP regulations, their similarities and differences.
Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems
Authors: Ranky Paul G. , Ranky Gregory N. , Ranky Richard G. , John Ashley 
Published: March 2010

Abstract
Total quality management (TQM) and operation control is an essential criteria in pharmaceutical manufacturing system design engineering. Quality control means establishing and maintaining specified quality standards of products in adherence to accepted criteria. This article provides methods and examples for designing and controlling TQM pharmaceutical manufacturing systems.
Role of Quality Systems and Audits in Pharmaceutical Manufacturing Environment
Authors: Siegel Evan B. , Barquest James M. 
Published: March 2010

Abstract
Quality assurance (QA) and independent audit is critical in the pharmaceutical industry to assure reliability of the products, adherence to approved specifications, and conformation of current good manufacturing practices (cGMP) to regulation. Manufacturers must establish a quality control unit that is responsible for quality‐related activities required by the regulations. This article focuses on role of quality assurance and independent audit in the pharmaceutical manufacturing environment.
Case for Process Analytical Technology: Regulatory and Industrial Perspectives
Authors: Cogdill Robert P. 
Published: March 2010

Abstract
Process analytical technology (PAT) has become an important part of the pharmaceutical manufacturing industry in the recent years. The Food and Drug Administration (FDA) initiative to implement a modern, risk‐based framework for regulation and oversight of pharmaceutical manufacturing has been a major driving force for the increase popularity of PAT. This article provides an overview of PAT in the pharmaceutical industry, summarizes FDA initiatives, and presents a basic plan for PAT implementation.
Process Analytical Technology
Authors: Ulmschneider Michel , Roggo Yves 
Published: March 2010

Abstract
The Food and Drug Administration (FDA) defines process analytical technology (PAT) as a system for designing, analyzing, and controlling pharmaceutical manufacturing through the measurement of critical quality and performance parameters. Process analytical technology encourages technological innovation by the pharmaceutical industry to improve the understanding and control of manufacturing processes. This article provides an overview of PAT and various tools of PAT.
Personnel Training in Pharmaceutical Manufacturing
Authors: Gallup David A. , Domenick Katherine V. , Gillis Marge 
Published: March 2010

Abstract
Competency and efficiency of pharmaceutical manufacturing personnel is critical to a safe and successful manufacturing process. The Code of Federal Regulations (CFR) provides mandatory rules for personnel training, while Food and Drug Administration (FDA) drafts guidance documents and good training practices (GTPs). This article focuses on how to develop and implement a training strategy that is compliant to CFR and FDA guidance.
Quantitation of Markers for Gram‐Negative and Gram‐Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatogaphy–Tandem Mass Spectrometry
Authors: Fox Alvin 
Published: March 2010

AbstractLipopolysaccharide (LPS) is an endotoxin present only in gram‐negative bacterial outer membranes, while peptidoglycan (PG), which displays endotoxin‐like activity, is present in the cell wall of gram‐positive and gram‐negative bacteria. Substances are found in LPS and PG that are rarely found elsewhere in nature and serve as chemical markers. This article focuses on detection of the markers for LPS and PG using gas chromatography–tandem mass spectrometry (GC–MS/MS).