Search results for: pharmacokinetics-in-drug-development

Pharmacokinetics in Drug Development

Author : Peter L. Bonate
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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.

Pharmacokinetics in Drug Development

Author : Peter L. Bonate
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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.

Pharmacokinetics in Drug Development

Author : Peter L. Bonate
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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.

Pharmacokinetics in Drug Development

Author : Peter L. Bonate
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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.

Pharmacokinetic Challenges in Drug Discovery

Author : O. Pelkonen
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Despite increased spending on research and development, the number of new medicines marketed successfully continues to decline. The Pharmaceutical industry is therefore focussing on ways to reduce attrition by addressing frequent reasons for clinical drug failures very early in the drug discovery process. One of the biggest challenges is the pharmacokinetic (PK) optimisation of drug candidates tailored and predicted to have appropriate absorption, distribution, metabolism and excretion (ADME) characteristics in human. This book describes how traditional pbarmacokinetic approaches and methods are being re-invented' to meet specific needs dictated by the dynamics of the drug discovery process. The book gives an overview of state-of-the-art tools and their use in the decision-making process is discussed by a number of scientists from leading pharmaceutical companies.

Pharmacokinetics in Drug Discovery and Development

Author : Ronald D. Schoenwald
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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 existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference. After an introduction of basic principles, the book is divided into sections that cover industrial and regulatory applications, clinical applications, and research applications. The following sections cover such topics as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, linear systems approaches, and more. Fourteen authors, each an expert in his/her area of expertise, provide an extensive background into the subspeciality with emphasis on the section's theme. Covering the many sub-disciplines and providing pharmacokinetic concepts, terminology, and approaches, Pharmacokinetics in Drug Discovery and Development serves as a resource for professionals throughout this field.

Drug Discovery and Evaluation

Author : H. Gerhard Vogel
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This book is a landmark in the continuously changing world of drugs. It is essential reading for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process.

Pharmacokinetics in Drug Development

Author : Umesh V. Banakar
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Integration of Pharmacokinetics Pharmacodynamics and Toxicokinetics in Rational Drug Development

Author : A. Yacobi
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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

Integration of Pharmacokinetics Pharmacodynamics and Toxicokinetics in Rational Drug Development

Author : A. Yacobi
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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

Pharmacokinetics and Metabolism in Drug Design

Author : Dennis A. Smith
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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.

Applications of Pharmacokinetic Principles in Drug Development

Author : Rajesh Krishna
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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.

Pharmacokinetics and Pharmacodynamics of Biotech Drugs

Author : Bernd Meibohm
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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.

Pharmacokinetics in Drug Development and Medical Practice

Author : Edward R. Garrett
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ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins

Author : Honghui Zhou
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"This book focuses on the fundamental and practical aspects of ADME and translational PK/PD for therapeutic proteins -- cutting-edge research, lessons learned from small molecules, the utility of ADME and translational PK/PD to guide lead optimization, first-in-human study dose projection and design, and clinical development and registration"--Provided by publisher.

Pharmacokinetics and Metabolism in Drug Design

Author : Dennis A. Smith
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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.

Drug Transporters

Author : Glynis Nicholls
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Understanding and quantifying the effects of membrane transporters within the human body is essential for modulating drug safety and drug efficacy. In this first volume on Drug Transporters, the current knowledge and techniques in the transporter sciences and their relations to drug metabolism and pharmacokinetics are comprehensively reviewed. The second volume of the book is specifically dedicated to emerging science and technologies, highlighting potential areas for future advances within the drug transporter field. The topics covered in both volumes ensure that all relevant aspects of transporters are described across the drug development process, from in silico models and preclinical tools through to the potential impact of transporters in the clinic. Contributions are included from expert leaders in the field, at-the-bench industrial scientists, renowned academics and international regulators. Case studies and emerging developments are highlighted, together with the merits and limitations of the available methods and tools, and extensive references to reviews on specific in-depth topics are also included for those wishing to pursue their knowledge further. As such, this text serves as an essential handbook of information for postgraduate students, academics, industrial scientists and regulators who wish to understand the role of transporters in absorption, distribution, metabolism, and excretion processes. In addition, it is also a useful reference tool on the models and calculations necessary to predict their effect on human pharmacokinetics and pharmacodynamics.

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

Author : Michelle A. Rudek
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There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer. Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs. Road map to anticancer drug development from discovery to NDA submission Discussion of molecular targets and preclinical screening Development and validation of bioanalytical methods Chapters on clinical trial design and phase 0, I, II, III clinical trials Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents Review of the drug development process from both laboratory and clinical perspectives New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development

PET for Drug Development and Evaluation

Author : D. Comar
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Can drug development and evaluation be improved by the use of positron emission tomography (PET)? PET is now well established and many PET centres participate in networks that warrant the quality of their research. PET allows one to follow the effect of a drug on a variety of patients' metabolic parameters. In addition, PET may be used to follow the fate in vivo of a compound, allowing visualisation of its binding to specific receptors and a direct study of the mechanism of drug action in normal and pathological situations. The book shows the fields in which PET offers new and unique information for the development of drugs (conception, toxicity, pharmacokinetics and metabolism, clinical research, and relations between clinical and biological effects) and evaluates fields in which PET may shorten the development time of drugs. Audience: Professionals in the pharmaceutical industry in all areas of drug discovery and pharmacology, pre-clinical testing, pharmacokinetics and metabolism, clinical evaluation, registration and regulatory affairs. Government health authority representatives who assess data and documentation on new drug development and radiopharmaceuticals. Academic experts concerned with any of these areas.

Drug Metabolism and Pharmacokinetics Quick Guide

Author : Siamak Cyrus Khojasteh
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Drug Metabolism and Pharmacokinetics Quick Guide covers a number of aspects of drug assessment at drug discovery and development stages, topics such as pharmacokinetics, absorption, metabolism, enzyme kinetics, drug transporters, drug interactions, drug-like properties, assays and in silico calculations. It covers key concepts, with useful tables on physiological parameters (eg. blood flow to organs in x-species, expression and localization of enzymes and transporters), chemical structure, nomenclature, and moieties leading to bioactivation (with examples). Overall it includes a number of key topics useful at the drug discovery stage, which would serve as a quick reference with several examples from the literature to illustrate the concept.