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 ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2015-10-26 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain
Download or read book Biotechnology and Biopharmaceuticals written by and published by John Wiley & Sons. This book was released on 2013-09-19 with total page 744 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.
Download or read book Biologics and Biosimilars written by Xiaodong Feng and published by CRC Press. This book was released on 2022-06-13 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.
Download or read book Interactions of Drugs Biologics and Chemicals in U S Military Forces written by Committee to Study the Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces and published by Compass Series. This book was released on 1996-11-14 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biopharmaceutics and Drug Interactions written by Donald E. Cadwallader and published by . This book was released on 1974 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Adverse Reactions to Biologics written by L. Puig and published by Karger Medical and Scientific Publishers. This book was released on 2017-11-07 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: In many areas of medicine physicians still face the great challenge of finding therapies that will meet the patients’ needs. In dermatology the challenge has arisen on multiple fronts through advances in the understanding of the immunopathogenesis of many inflammatory and malignant cutaneous disorders. Breakthroughs, combined with significant developments in targeted immunotherapy, have resulted in improved outcomes as these newer therapies are being used for both approved indications and as off-label therapies for various chronic inflammatory skin disorders and many forms of skin cancer. In the expectation that by truly understanding the safety profile of these targeted therapies patients’ outcomes will be significantly improved, this book offers insights into topics such as adverse reactions, infectious complications and the perioperative use of biologics in psoriasis, immunogenicity of biologic therapies, paradoxical reactions, safety of biologics used to treat autoimmune bullous diseases and primary cutaneous lymphomas, adverse reactions and skin manifestations of therapies targeting melanoma and non-melanoma skin cancer and other neoplastic diseases. Eminent researchers with extensive clinical experience have contributed to this publication, providing an in-depth overview of the latest knowledge in this field.
Download or read book Drug Discovery and Evaluation Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
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 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 Biopharmaceutics Applications in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2007-09-20 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.
Download or read book Developing Multimodal Therapies for Brain Disorders written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-02-13 with total page 97 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multimodal therapy approaches that combine interventions aimed at different aspects of disease are emerging as potentialâ€"and perhaps essentialâ€"ways to enhance clinical outcomes for patients with psychiatric and neurological disorders. In order to examine the general principles underlying multimodal therapies and to explore challenges, potential barriers, and opportunities for their development, the National Academies of Sciences, Engineering, and Medicine convened a workshop in June 2016. Participants explored scientific, clinical, regulatory, and reimbursement issues related to multimodal approaches and potential opportunities to enhance clinical outcomes for individuals with nervous system disorders. This publication summarizes the presentations and discussions from the workshop.
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 469 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. 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 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 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 Drug Drug Interactions written by Dong Hyun Kim and published by Mdpi AG. This book was released on 2021-09-17 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-drug interactions (DDIs) cause a drug to affect other drugs, leading to reduced drug efficacy or increased toxicity of the affected drug. Some well-known interactions are known to be the cause of adverse drug reactions (ADRs) that are life threatening to the patient. Traditionally, DDI have been evaluated around the selective action of drugs on specific CYP enzymes. The interaction of drugs with CYP remains very important in drug interactions but, recently, other important mechanisms have also been studied as contributing to drug interaction including transport- or UDP-glucuronyltransferase as a Phase II reaction-mediated DDI. In addition, novel mechanisms of regulating DDIs can also be suggested. In the case of the substance targeted for interaction, not only the DDIs but also the herb-drug or food-drug interactions have been reported to be clinically relevant in terms of adverse side effects. Reporting examples of drug interactions on a marketed drug or studies on new mechanisms will be very helpful for preventing the side effects of the patient taking these drugs. This Special Issue aims to highlight current progress in understanding both the clinical and nonclinical interactions of commercial drugs and the elucidation of the mechanisms of drug interactions.
