Pharmacodynamics and Drug Development PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Pharmacodynamics and Drug Development PDF full book. Access full book title Pharmacodynamics and Drug Development by Neal R. Cutler. Download full books in PDF and EPUB format.
Author: Neal R. Cutler Publisher: John Wiley & Sons ISBN: 9780471950523 Category : Medical Languages : en Pages : 514
Book Description
Contains essential facts and concepts spanning many of the important drug classes. Features an authoritative section on general methodology and regulatory issues. The molecular biology and pharmacology of key receptor types are considered along with the detailed pharmacodynamics of a wide range of therapeutic drug groups.
Author: Neal R. Cutler Publisher: John Wiley & Sons ISBN: 9780471950523 Category : Medical Languages : en Pages : 514
Book Description
Contains essential facts and concepts spanning many of the important drug classes. Features an authoritative section on general methodology and regulatory issues. The molecular biology and pharmacology of key receptor types are considered along with the detailed pharmacodynamics of a wide range of therapeutic drug groups.
Author: Peter L. Bonate Publisher: Springer Science & Business Media ISBN: 1441994858 Category : Medical Languages : en Pages : 634
Book Description
This is a second edition to the original published by Springer in 2006. The comprehensive volume takes a textbook approach systematically developing the field by starting from linear models and then moving up to generalized linear and non-linear mixed effects models. Since the first edition was published the field has grown considerably in terms of maturity and technicality. The second edition of the book therefore considerably expands with the addition of three new chapters relating to Bayesian models, Generalized linear and nonlinear mixed effects models, and Principles of simulation. In addition, many of the other chapters have been expanded and updated.
Author: Honghui Zhou Publisher: John Wiley & Sons ISBN: 111889880X Category : Medical Languages : en Pages : 479
Book Description
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
Author: Honghui Zhou Publisher: John Wiley & Sons ISBN: 1118630211 Category : Medical Languages : en Pages : 272
Book Description
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.
Author: Honghui Zhou Publisher: John Wiley & Sons ISBN: 111928922X Category : Medical Languages : en Pages : 518
Book Description
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.
Author: Arthur J. Atkinson Jr. Publisher: Gulf Professional Publishing ISBN: 9780120660605 Category : Medical Languages : en Pages : 490
Book Description
The rate of introduction of new pharmaceutical products has increased rapidly over the past decade, and details learned about a particular drug become obsolete as it is replaced by newer agents. For this reason, this book focuses on the principles that underlie the clinical use and contemporary development of pharmaceuticals. The coverage of these principles that is presented in this book will be of particular benefit to individuals engaged either in the teaching or study of sound therapeutic technique or in the investigation of pharmacological agents. Key Features * Unique breadth of coverage ranging from drug discovery and development to individualization and quality assessment of drug therapy * Unusual cohesiveness of presentation that stems from author participation in an ongoing popular NIH course * Instructive linkage of pharmacokinetic theory and applications with provision of sample problems for self-study * Wide-ranging perspective of authors drawn from the ranks of Federal agencies, academia and the pharmaceutical industry
Author: Mark Rogge Publisher: CRC Press ISBN: 1420084739 Category : Medical Languages : en Pages : 374
Book Description
Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: PharmacokineticsModeling and simula
Author: Ene I. Ette Publisher: John Wiley & Sons ISBN: 1118679512 Category : Medical Languages : en Pages : 1236
Book Description
Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies.
Author: Ting-Chao Chou Publisher: Elsevier ISBN: 0443288755 Category : Science Languages : en Pages : 440
Book Description
"Mass-Action Law Dynamics Theory and Algorithm for Translational and Precision Medicine Informatics provides a comprehensive overview and update of the mass-action law-based unified dose-effect biodynamics, pharmacodynamics, bioinformatics, and the combination index theorem for synergy definition (MAL-BD/PD/BI/CI). Contents advocate the fundamental MAL-PD/BI/CI/BI principle for biomedical R&D, clinical trials protocol design computerized data analysis, illustrates the MAL-dynamics theory with sample analysis, and includes data entry and automated computer report print-outs. In 11 sections "Mass-Action Law Dynamics Theory and Algorithm for Translational and Precision Medicine Informatics leads the reader from an introduction and overview, to trial protocols and MAL-PD/CI approach for biomedical R&D in vitro and in animals. It describes the current Landscape of International FDA Drug Evaluation, Clinical Pharmacology, and Clinical Trials Guidance. This is a valuable resource for biomedical researchers, healthcare professionals, and students seeking to harness the power of data informatics in precision medicine.• gives insight into that index equation (DRIE) that digitally determines how many folds of dose-reduction is needed for each drug in synergistic combinations • provides a comprehensive overview and update of mass-action law-based unified bioinformatics, dose effect biodynamics, pharmacodynamics, and the combination index theorem for synergy definition (MAL-BD/PD/BI/CI) • describes how the MAL theory/algorithm-based "Top-Down digital approach is the opposite and yet is a complementary alternative to the observation/statistics-based "Bottom-Up traditional approach in R&D
Author: Neal R. Cutler
Author: Neal R. Cutler
Author: Peter L. Bonate
Author: 
Author: Honghui Zhou
Author: Honghui Zhou
Author: Honghui Zhou
Author: Arthur J. Atkinson Jr.
Author: Mark Rogge
Author: Ene I. Ette
Author: Ting-Chao Chou