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Drug Drug Interactions In Pharmaceutical Development

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Drug Drug Interactions In Pharmaceutical Development

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Author : Binghe Wang
language : en
Publisher: John Wiley & Sons
Release Date : 2008-03-05

Drug Drug Interactions In Pharmaceutical Development written by Binghe Wang and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-05 with Medical categories.

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.

Drug Drug Interactions In Pharmaceutical Development

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Author : Binghe Wang
language : en
Publisher: John Wiley & Sons
Release Date : 2008-03-05

Drug Drug Interactions For Therapeutic Biologics

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Author : Honghui Zhou
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-10

Drug Drug Interactions For Therapeutic Biologics written by Honghui Zhou and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-10 with Medical categories.

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.

Pharmacokinetics In Drug Development

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Author : Peter L. Bonate
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-02-21

Pharmacokinetics In Drug Development written by Peter L. Bonate and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-02-21 with Medical categories.

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.

Evaluation Of Drug Candidates For Preclinical Development

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Author : Chao Han
language : en
Publisher: John Wiley & Sons
Release Date : 2010-01-06

Evaluation Of Drug Candidates For Preclinical Development written by Chao Han and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-01-06 with Medical categories.

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.

Drug Metabolism In Drug Design And Development

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Author : Donglu Zhang
language : en
Publisher: John Wiley & Sons
Release Date : 2007-11-16

Drug Metabolism In Drug Design And Development written by Donglu Zhang and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-16 with Science categories.

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.

Applications Of Pharmacokinetic Principles In Drug Development

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Author : Rajesh Krishna
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

Applications Of Pharmacokinetic Principles In Drug Development written by Rajesh Krishna and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.

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.

Principles And Practice Of Pharmaceutical Medicine

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Author : Lionel D. Edwards
language : en
Publisher: John Wiley & Sons
Release Date : 2011-07-12

Principles And Practice Of Pharmaceutical Medicine written by Lionel D. Edwards and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-07-12 with Medical categories.

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.

Pharmacokinetics In Drug Discovery And Development

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Author : Ronald D. Schoenwald
language : en
Publisher: CRC Press
Release Date : 2002-03-06

Pharmacokinetics In Drug Discovery And Development written by Ronald D. Schoenwald and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-03-06 with Medical categories.

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

Translating Molecules Into Medicines

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Author : Shobha N. Bhattachar
language : en
Publisher: Springer
Release Date : 2017-04-21

Translating Molecules Into Medicines written by Shobha N. Bhattachar and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-21 with Medical categories.

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.

Drug Drug Interactions In Pharmaceutical Development

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