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Drug Drug Interactions In Pharmaceutical Development
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Book Synopsis Drug-Drug Interactions in Pharmaceutical Development by : Binghe Wang
Download or read book Drug-Drug Interactions in Pharmaceutical Development written by Binghe Wang and published by John Wiley & Sons. This book was released on 2008-03-05 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage.
Book Synopsis Drug-drug Interactions in Pharmaceutical Development by : Binghe Wang
Download or read book Drug-drug Interactions in Pharmaceutical Development written by Binghe Wang and published by John Wiley & Sons. This book was released on 2008-03-05 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage.
Book Synopsis Drug-Drug Interactions for Therapeutic Biologics by : Honghui Zhou
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.
Book Synopsis Pharmacokinetics in Drug Development by : Peter L. Bonate
Download or read book Pharmacokinetics in Drug Development written by Peter L. Bonate and published by Springer Science & Business Media. This book was released on 2011-02-21 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection. Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry.
Book Synopsis Drug Metabolism in Drug Design and Development by : Donglu Zhang
Download or read book Drug Metabolism in Drug Design and Development written by Donglu Zhang and published by John Wiley & Sons. This book was released on 2007-11-16 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essentials of drug metabolism vital to developing new therapeutic entities Information on the metabolism and disposition of candidate drugs is a critical part of all aspects of the drug discovery and development process. Drug metabolism, as practiced in the pharmaceutical industry today, is a complex, multidisciplinary field that requires knowledge of sophisticated analytical technologies and expertise in mechanistic and kinetic enzymology, organic reaction mechanism, pharmacokinetic analysis, animal physiology, basic chemical toxicology, preclinical pharmacology, and molecular biology. With chapters contributed by experts in their specific areas, this reference covers: * Basic concepts of drug metabolism * The role of drug metabolism in the pharmaceutical industry * Analytical techniques in drug metabolism * Common experimental approaches and protocols Drug Metabolism in Drug Design and Development emphasizes practical considerations such as the data needed, the experiments and analytical methods typically employed, and the interpretation and application of data. Chapters highlight facts, common protocols, detailed experimental designs, applications, and limitations of techniques. This is a comprehensive, hands-on reference for drug metabolism researchers as well as other professionals involved in pre-clinical drug discovery and development.
Book Synopsis Pharmacokinetics in Drug Discovery and Development by : Ronald D. Schoenwald
Download or read book Pharmacokinetics in Drug Discovery and Development written by Ronald D. Schoenwald and published by CRC Press. This book was released on 2002-03-06 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existi
Book Synopsis Applications of Pharmacokinetic Principles in Drug Development by : Rajesh Krishna
Download or read book Applications of Pharmacokinetic Principles in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in later, more expensive clinical development programs. of Pharmacokinetics and pharmacodynamics have become an important component understanding the drug action on the body and is becoming increasingly important in drug labeling due to it's potential for predicting drug behavior in populations that may be difficult to study in adequate numbers during drug development. The ability to correlate drug exposure to effect and model it during the drug development value chain provides valuable insight into optimizing the next steps to derive maximum information from each study. These principles and modeling techniques have resulted in an expanded and integrated view of PK and PO and have led to the expectations that we may be able to optimally design clinical trials and eventually lead us to identifying the optimal therapy for the patient, while minimizing cost and speeding up drug development. There is wide utility for the book both as a text and as a reference.
Book Synopsis Evaluation of Drug Candidates for Preclinical Development by : Chao Han
Download or read book Evaluation of Drug Candidates for Preclinical Development written by Chao Han and published by John Wiley & Sons. This book was released on 2010-01-06 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emphasizes the integration of major areas of drug discovery and their importance in candidate evaluation It is believed that selecting the "right" drug candidate for development is the key to success. In the last decade, pharmaceutical R&D departments have integrated pharmacokinetics and drug metabolism, pharmaceutics, and toxicology into early drug discovery to improve the assessment of potential drug compounds. Now, Evaluation of Drug Candidates for Preclinical Development provides a complete view and understanding of why absorption-distribution-metabolism-excretion-toxicology (ADMET) plays a pivotal role in drug discovery and development. Encompassing the three major interrelated areas in which optimization and evaluation of drug developability is most critical pharmacokinetics and drug metabolism, pharmaceutics, and safety assessment this unique resource encourages integrated thinking in drug discovery. The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability issues that challenge pharma companies, moving beyond isolated experimental results Reveal connections between the key scientific areas that are critical for successful drug discovery and development Inspire forward-thinking strategies and decision-making processes in preclinical evaluation to maximize the potential of drug candidates to progress through development efficiently and meet the increasing demands of the marketplace Evaluation of Drug Candidates for Preclinical Development serves as an introductory reference for those new to the pharmaceutical industry and drug discovery in particular. It is especially well suited for scientists and management teams in small- to mid-sized pharmaceutical companies, as well as academic researchers and graduate students concerned with the practical aspects related to the evaluation of drug developability.
Book Synopsis Drug Interactions by : Ivan H. Stockley
Download or read book Drug Interactions written by Ivan H. Stockley and published by . This book was released on 1996 with total page 1018 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a source book of adverse drug reactions covering their clinical importance, mechanisms and management. This fourth edition has been revised from an extensive database. Major interaction mechanisms are followed by alphabetically-arranged material covering all the drug groups. As with prior editions, there is a series of monographs with a consistent plan devised to offer quick and easy reading. Both British and American drug names have been used throughout the book and bibliogrpahies are provided for those who wish to use the book as a reference source.
Book Synopsis Drug-Drug Interactions by : A. David Rodrigues
Download or read book Drug-Drug Interactions written by A. David Rodrigues and published by CRC Press. This book was released on 2019-01-03 with total page 769 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:key interplay between transporters and enzymes
Book Synopsis Drug-Drug Interactions: Scientific and Regulatory Perspectives by :
Download or read book Drug-Drug Interactions: Scientific and Regulatory Perspectives written by and published by Academic Press. This book was released on 1997-11-06 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Drug Interactions is a comprehensive review of the scientific and regulatory perspectives of drug drug interactions from the point-of-view of academia, industry, and government regulatory agencies. This book is intended for professionals in the pharmaceutical industry, health care, and governmental regulatory agencies. Topics of interest include the mechanistic understanding of drug drug interactions, the prediction of drug drug interaction potential of new drugs, and the avoidance of clinically significant drug drug interaction in patients. Provides useful references on the science of drug-drug interactions Describes in a basic and comprehensive manner drug-drug interactions from the mechanistic viewpoint Contains original data from academic and industrial laboratories Presents an overview of regulatory agency positions
Book Synopsis Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development by : A. Yacobi
Download or read book Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development written by A. Yacobi and published by Springer Science & Business Media. This book was released on 2013-11-11 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proceedings of a conference sponsored by the American Association of Pharmaceutical Scientists, the U.S. Food and Drug Administration, and the American Society for Clinical Pharmacology and Therapeutics, held in Arlington, Virginia, April 24-26, 1991
Book Synopsis Translating Molecules into Medicines by : Shobha N. Bhattachar
Download or read book Translating Molecules into Medicines written by Shobha N. Bhattachar and published by Springer. This book was released on 2017-04-21 with total page 471 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field. The authors of each chapter address the paradox between the molecular understanding of diseases, drug discovery, and drug development. Laying out the detailed trends from various fields, different chapters are dedicated to target engagement, toxicological safety assessments, and the compelling relationship of optimizing early clinical studies with design strategies. The book also highlights the importance of balancing the three pillars: sufficient efficacy, acceptable safety and appropriate pharmacokinetics, all of which are crucial to successful efforts in discovery and development. With discussions regarding the combined approaches of molecular research, personalized medicine, pre-clinical and clinical development, as well as targeted therapies—this compendium is a flexible fit, perfect for professionals in the pharmaceutical industry and related academic fields.
Book Synopsis Principles and Practice of Pharmaceutical Medicine by : Lionel D. Edwards
Download or read book Principles and Practice of Pharmaceutical Medicine written by Lionel D. Edwards and published by John Wiley & Sons. This book was released on 2011-07-12 with total page 1109 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.
Book Synopsis Drug Interaction Studies During Drug Development by : Jochen Kuhlmann
Download or read book Drug Interaction Studies During Drug Development written by Jochen Kuhlmann and published by W. Zuckschwerdt. This book was released on 1994-01-01 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine
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.
Book Synopsis The ESC Textbook of Cardiovascular Medicine by : A. John Camm
Download or read book The ESC Textbook of Cardiovascular Medicine written by A. John Camm and published by . This book was released on 2019 with total page 3198 pages. Available in PDF, EPUB and Kindle. Book excerpt:
