Download or read book Drug Drug Interactions for Therapeutic Biologics written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2013-05-10 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.
Download or read book Biologics Biosimilars and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Download or read book Therapeutic Plasma Exchange written by H.-J. Gurland and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume contains papers and discussions of the Vlth Dialyse-Arzte Workshop, which was held in Bernried at Lake Starnberg near Munich the 5th and 6th of March 1980. Generous ly sponsored by Travenol, Munich, the Dialyse-Arzte meetings now have a tradition spanning 16 years. According to the con stitution of these meetings, the topics of earlier years had to cover dialysis and related fields. Thus the sponsor requested that this year also one lecture - incorporated here as part - should deal with the state of art of dialysis, thereby hopefully linking this Workshop to the previous meetings. Dialysis techniques of the 1960s, pioneered by many of attend ing speakers and panelists (see List of Contributors), have never come to a standstill. Indeed, vascular access and extra corporeal circulation have become routine for the nephrologist and have made possible the introductimn of new approaches, such as hemofiltration and hemoperfusion. Also today new membrane technologies provide us with a potentially even more effective therapeutic tool, namely plasma separation.
Download or read book Therapeutic Antibody Engineering written by William R Strohl and published by Elsevier. This book was released on 2012-10-16 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. - Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships - Integration of knowledge across all areas of antibody engineering, development, and marketing - Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Pharmacokinetics and Pharmacodynamics of Biotech Drugs written by Bernd Meibohm and published by John Wiley & Sons. This book was released on 2006-12-13 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.
Download or read book Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2019-02-14 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thorough Overview Identifies and Addresses Critical Gaps in the Treatment of Several Chronic Diseases With increasing numbers of patients suffering from Immune-Mediated Inflammatory Diseases (IMIDs), and with the increasing reliance on biopharmaceuticals to treat them, it is imperative that researchers and medical practitioners have a thorough understanding of the absorption, distribution, metabolism and excretion (ADME) of therapeutic proteins as well as translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for them. This comprehensive volume answers that need to be addressed. Featuring eighteen chapters from world-renowned experts and opinion leaders in pharmacology, translational medicine and immunology, editors Honghui Zhou and Diane Mould have curated a much-needed collection of research on the advanced applications of pharmacometrics and systems pharmacology to the development of biotherapeutics and individualized treatment strategies for the treatment of IMIDs. Authors discuss the pathophysiology of autoimmune diseases in addition to both theoretical and practical aspects of quantitative pharmacology for therapeutic proteins, current translational medicine research methodologies and novel thinking in treatment paradigm strategies for IMIDs. Other notable features include: • Contributions from well-known authors representing leading academic research centers, specialized contract research organizations and pharmaceutical industries whose pipelines include therapeutic proteins • Chapters on a wide range of topics (e.g., pathophysiology of autoimmune diseases, biomarkers in ulcerative colitis, model-based meta-analysis use in the development of therapeutic proteins) • Case studies of applying quantitative pharmacology approaches to guiding therapeutic protein drug development in IMIDs such as psoriasis, inflammatory bowel disease, multiple sclerosis and lupus Zhou and Mould’s timely contribution to the critical study of biopharmaceuticals is a valuable resource for any academic and industry researcher working in pharmacokinetics, pharmacology, biochemistry, or biotechnology as well as the many clinicians seeking the safest and most effective treatments for patients dealing with chronic immune disorders.
Download or read book Identification and Quantification of Drugs Metabolites Drug Metabolizing Enzymes and Transporters written by Shuguang Ma and published by Elsevier Science. This book was released on 2020-07-24 with total page 708 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade's numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics All chapters are written by experts with a wide range of practical experience from the industry and academia
Download or read book Identification and Quantification of Drugs Metabolites Drug Metabolizing Enzymes and Transporters written by Shuguang Ma and published by Elsevier. This book was released on 2020-07-09 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade's numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. - Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues - Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included - Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics - All chapters are written by experts with a wide range of practical experience from the industry and academia
Download or read book Mechanisms of Drug Interactions written by Patrick F. D'Arcy and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the years a number of excellent books have classified and detailed drug drug interactions into their respective categories, e.g. interactions at plasma protein binding sites; those altering intestinal absorption or bioavailability; those involving hepatic metabolising enzymes; those involving competition or antagonism for receptor sites, and drug interactions modifying excretory mechanisms. Such books have presented extensive tables of interactions and their management. Although of considerable value to clinicians, such publica tions have not, however, been so expressive about the individual mechanisms that underlie these interactions. It is within this sphere of "mechanisms" that this present volume specialises. It deals with mechanisms of in vitro and in vivo, drug-drug, drug food and drug-herbals interactions and those that cause drugs to interfere with diagnostic laboratory tests. We believe that an explanation of the mechanisms of such interactions will enable practitioners to understand more fully the nature of the interactions and thus enable them to manage better their clinical outcome. If mechanisms of interactions are better understood, then it may be pos sible for the researcher to develop meaningful animal/biochemical/tissue cul ture or physicochemical models to which new molecules could be exposed during their development stages. The present position, which largely relies on patients experiencing adverse interactions before they can be established or documented, can hardly be regarded as satisfactory. This present volume is classified into two major parts; firstly, pharmacoki netic drug interactions and, secondly, pharmacodynamic drug interactions.
Download or read book Oral Bioavailability and Drug Delivery written by Ming Hu and published by John Wiley & Sons. This book was released on 2024-01-18 with total page 932 pages. Available in PDF, EPUB and Kindle. Book excerpt: ORAL BIOAVAILABILITY AND DRUG DELIVERY Improve the performance and viability of newly-developed and approved drugs with this crucial guide Bioavailability is the parameter which measures the rate and extent to which a drug reaches a user’s circulatory system depending on the method of administration. For example, intravenous administration produces a bioavailability of 100%, since the drugs are injected directly into the circulatory system; in the case of oral administration, however, bioavailability can vary widely based on factors which, if not properly understood, can result in a failure in drug development, adverse effects, and other complications. The mechanics of oral bioavailability are therefore critical aspects of drug development. Oral Bioavailability and Drug Delivery provides a comprehensive coverage of this subject as well as its drug development applications. Beginning with basic terminology and fundamental concepts, it provides a thorough understanding of the challenges and barriers to oral bioavailability as well as the possibilities for improving this parameter. The resulting book is an indispensable tool for drug development research. Oral Bioavailability and Drug Delivery readers will also find: Discussion questions in many chapters to facilitate comprehension Detailed discussion of topics including dissolution, absorption, metabolism, and more Real-world examples of methods in actions throughout Oral Bioavailability and Drug Delivery is ideal for pharmaceutical and biotechnology scientists working in drug discovery and development; researchers in chemistry, biology, pharmacology, immunology, neuroscience, and other related fields; and graduate courses in drug development and delivery.
Download or read book CDC Yellow Book 2018 Health Information for International Travel written by Centers for Disease Control and Prevention CDC and published by Oxford University Press. This book was released on 2017-04-17 with total page 705 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
Download or read book Proteins and Peptides written by Randall J. Mrsny and published by CRC Press. This book was released on 2009-10-19 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Addressing the increased use of protein and peptide candidates as treatments for previously untreatable diseases, this comprehensive and progressive source provides the reader with a roadmap to an increased understanding of issues critical for successfully developing a protein or peptide therapeutic candidate. Proteins and Peptides is
Download or read book Translational Medicine written by Robert A. Meyers and published by John Wiley & Sons. This book was released on 2018-07-16 with total page 1064 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieses Referenzwerk bietet einen vollständigen Überblick über die verschiedenen Phasen der Wirkstoffentwicklung und greift dabei auf einen translationalen Ansatz zurück.
Download or read book Biological Drug Products written by Wei Wang and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Download or read book Drug Metabolism Handbook written by Ala F. Nassar and published by John Wiley & Sons. This book was released on 2009-01-28 with total page 1059 pages. Available in PDF, EPUB and Kindle. Book excerpt: A valuable reference tool for professionals involved in the industry, Drug Metabolism in Pharmaceuticals covers new tools such as LC-MS and LC-MS-NMR along with experimental aspects of drug metabolism. This work fills a gap in the literature by covering the concepts and applications of pharmaceutical research, development, and assessment from the point of view of drug metabolism. By providing both a solid conceptual understanding of the drug metabolism system, and a well illustrated, detailed demonstration and explanation of cutting edge tools and techniques, this book serves as a valuable reference tool for bench scientists, medical students, and students of general health sciences.
