Pharmacokinetics In Drug Development

Author : Peter L. Bonate,Danny R. Howard
Publisher : Springer
Page : 330 pages
File Size : 53,5 Mb
Release : 2016-10-06
Category : Medical
ISBN : 9783319390536

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Pharmacokinetics in Drug Development by Peter L. Bonate,Danny R. Howard Pdf

In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely – to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist’s point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.

Author : Ronald D. Schoenwald
Publisher : CRC Press
Page : 430 pages
File Size : 51,5 Mb
Release : 2002-03-06
Category : Medical
ISBN : 9781420010084

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Pharmacokinetics in Drug Discovery and Development by Ronald D. Schoenwald Pdf

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

Author : Peter L. Bonate
Publisher : Springer Science & Business Media
Page : 648 pages
File Size : 46,5 Mb
Release : 2005-12-05
Category : Medical
ISBN : 0971176744

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Pharmacokinetics in Drug Development by Peter L. Bonate Pdf

These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. They fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

Author : Rajesh Krishna
Publisher : Springer Science & Business Media
Page : 556 pages
File Size : 46,8 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9781441992161

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Applications of Pharmacokinetic Principles in Drug Development by Rajesh Krishna Pdf

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.

Author : Bernd Meibohm
Publisher : John Wiley & Sons
Page : 426 pages
File Size : 47,6 Mb
Release : 2006-12-13
Category : Science
ISBN : 9783527609529

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Pharmacokinetics and Pharmacodynamics of Biotech Drugs by Bernd Meibohm Pdf

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.

Author : Peter L. Bonate,Danny R. Howard
Publisher : Springer Science & Business Media
Page : 325 pages
File Size : 42,7 Mb
Release : 2011-02-21
Category : Medical
ISBN : 9781441979377

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Pharmacokinetics in Drug Development by Peter L. Bonate,Danny R. Howard Pdf

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.

Author : Peter L. Bonate,Danny R. Howard
Publisher : Springer Science & Business Media
Page : 516 pages
File Size : 53,6 Mb
Release : 2005-12-05
Category : Medical
ISBN : 0971176736

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Pharmacokinetics in Drug Development by Peter L. Bonate,Danny R. Howard Pdf

These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. The volumes fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

Author : Dennis A. Smith,Charlotte Allerton,Amit S. Kalgutkar,Han van de Waterbeemd,Don K. Walker
Publisher : John Wiley & Sons
Page : 269 pages
File Size : 44,7 Mb
Release : 2012-05-14
Category : Medical
ISBN : 9783527329540

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Pharmacokinetics and Metabolism in Drug Design by Dennis A. Smith,Charlotte Allerton,Amit S. Kalgutkar,Han van de Waterbeemd,Don K. Walker Pdf

In this new edition of a bestseller, all the contents have been brought upto-date by addressing current standards and best practices in the assessment and prediction of ADMET properties. Although the previous chapter layout has been retained, substantial revisions have been made, with new topics such as pro-drugs, active metabolites and transporters covered in detail in a manner useful to the Drug Discovery scientist. The authors discuss the parameters and processes important for the absorption, distribution and retention of drug compounds in the body, plus the potential problems created by their transformation into toxic byproducts. While aimed at all those dealing professionally with the development and application of pharmaceutical substances, the readily comprehensible style makes this book equally suitable for students of pharmacy and related subjects. Uniquely comprehensive, the book relates physicochemistry and chemical structure to pharmacokinetic properties and ultimately drug efficacy and safety.

Author : Dennis A. Smith,Han van de Waterbeemd,Don K. Walker
Publisher : John Wiley & Sons
Page : 218 pages
File Size : 50,5 Mb
Release : 2006-05-01
Category : Medical
ISBN : 3527313680

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Pharmacokinetics and Metabolism in Drug Design by Dennis A. Smith,Han van de Waterbeemd,Don K. Walker Pdf

In this new edition of a bestseller, all the contents have been updated and new material has been added, especially in the areas of toxicity testing and high throughput analysis. The authors, all of them employed at Pfizer in the discovery and development of new active substances, discuss the significant parameters and processes important for the absorption, distribution and retention of drug compounds in the body, plus the potential problems created by their transformation into toxic byproducts. They cover everything from the fundamental principles right up to the impact of pharmacokinetic parameters on the discovery of new drugs. While aimed at all those dealing professionally with the development and application of pharmaceutical substances, the readily comprehensible style makes this book equally suitable for students of pharmacy and related subjects.

Author : Younggil Kwon
Publisher : Springer Science & Business Media
Page : 291 pages
File Size : 52,5 Mb
Release : 2007-05-08
Category : Medical
ISBN : 9780306468209

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Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists by Younggil Kwon Pdf

In the pharmaceutical industry, the incorporation of the disciplines of pharma- kinetics, pharmacodynamics, and drug metabolism (PK/PD/DM) into various drug development processes has been recognized to be extremely important for approp- ate compound selection and optimization. During discovery phases, the identifi- tion of the critical PK/PD/DM issues of new compounds plays an essential role in understanding their pharmacological profiles and structure-activity relationships. Owing to recent progress in analytical chemistry, a large number of compounds can be screened for their PK/PD/DM properties within a relatively short period of time. During development phases as well, the toxicology and clinical study designs and trials of a compound should be based on a thorough understanding of its PK/PD/DM properties. During my time as an industrial scientist, I realized that a reference work designed for practical industrial applications of PK/PD/DM could be a very valuable tool for researchers not only in the pharmacokinetics and drug metabolism departments, but also for other discovery and development groups in pharmaceutical companies. This book is designed specifically for industrial scientists, laboratory assistants, and managers who are involved in PK/PD/DM-related areas. It consists of thirteen chapters, each of which deals with a particular PK/PD/DM issue and its industrial applications. Chapters 3 and 12 in particular address recent topics on higher throughput in vivo exposure screening and the prediction of pharmacokinetics in humans, respectively. Chapter 8 covers essential information on drug metabolism for industrial scientists.

Author : Dennis A. Smith,Han van de Waterbeemd,Don K. Walker
Publisher : John Wiley & Sons
Page : 207 pages
File Size : 51,8 Mb
Release : 2006-08-21
Category : Medical
ISBN : 9783527608287

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Pharmacokinetics and Metabolism in Drug Design by Dennis A. Smith,Han van de Waterbeemd,Don K. Walker Pdf

In this new edition of a bestseller, all the contents have been updated and new material has been added, especially in the areas of toxicity testing and high throughput analysis. The authors, all of them employed at Pfizer in the discovery and development of new active substances, discuss the significant parameters and processes important for the absorption, distribution and retention of drug compounds in the body, plus the potential problems created by their transformation into toxic byproducts. They cover everything from the fundamental principles right up to the impact of pharmacokinetic parameters on the discovery of new drugs. While aimed at all those dealing professionally with the development and application of pharmaceutical substances, the readily comprehensible style makes this book equally suitable for students of pharmacy and related subjects.

Author : Ntambwe Malangu
Publisher : BoD – Books on Demand
Page : 164 pages
File Size : 45,6 Mb
Release : 2018-05-23
Category : Medical
ISBN : 9781789231380

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Pharmacokinetics and Adverse Effects of Drugs by Ntambwe Malangu Pdf

This book is a fruit of a collaborative work from several international scientists. It will be a useful resource for researchers, students, and clinicians. Each individual chapter could serve as a prescribed reading for postgraduate students and clinicians specializing in and practicing clinical pharmacology and toxicology, pharmacotherapy and pharmacotherapeutics, pharmacovigilance, and toxicovigilance, as well as those involved in clinical research, drug discovery, and development. Every chapter in this book discusses and provides illustrations on the theme discussed based on authors' understanding and experience while summarizing existing knowledge. In doing so, each chapter provides a new insight that would benefit a novice as well as a seasoned reader in understanding the pharmacokinetic mechanisms and risk factors involved in the occurrence of adverse effects of drugs.

Author : Umesh V. Banakar,Michael C. Makoid
Publisher : CRC PressI Llc
Page : 493 pages
File Size : 55,5 Mb
Release : 1997-11-01
Category : Medical
ISBN : 1566766222

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Pharmacokinetics in Drug Development by Umesh V. Banakar,Michael C. Makoid Pdf

Author : A. Yacobi,J.P. Skelly,Vinod P. Shah,L.Z. Benet
Publisher : Springer Science & Business Media
Page : 266 pages
File Size : 45,5 Mb
Release : 2013-11-11
Category : Medical
ISBN : 9781475715200

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Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development by A. Yacobi,J.P. Skelly,Vinod P. Shah,L.Z. Benet Pdf

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

Author : H. Gerhard Vogel,Jochen Maas,Franz J. Hock,Dieter Mayer
Publisher : Springer
Page : 0 pages
File Size : 43,6 Mb
Release : 2013-02-27
Category : Medical
ISBN : 3642252397

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by H. Gerhard Vogel,Jochen Maas,Franz J. Hock,Dieter Mayer Pdf

-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide