Pharmacodynamics And Drug Development
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Pharmacodynamics And Drug Development
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Author : Neal R. Cutler
language : en
Publisher: John Wiley & Sons
Release Date : 1994-09-20
Pharmacodynamics And Drug Development written by Neal R. Cutler 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 1994-09-20 with Medical categories.
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.
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.
Integration Of Pharmacokinetics Pharmacodynamics And Toxicokinetics In Rational Drug Development
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Author : A. Yacobi
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-11-11
Integration Of Pharmacokinetics Pharmacodynamics And Toxicokinetics In Rational Drug Development written by A. Yacobi 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 2013-11-11 with Medical categories.
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 Pharmacodynamics Of Biotech Drugs
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Author : Bernd Meibohm
language : en
Publisher: John Wiley & Sons
Release Date : 2006-12-13
Pharmacokinetics And Pharmacodynamics Of Biotech Drugs written by Bernd Meibohm 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 2006-12-13 with Science categories.
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
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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.
Pharmacokinetics In Drug Development
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Author : Peter L. Bonate
language : en
Publisher: Springer
Release Date : 2016-10-06
Pharmacokinetics In Drug Development written by Peter L. Bonate and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-06 with Medical categories.
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.
Systems Pharmacology And Pharmacodynamics
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Author : Donald E. Mager
language : en
Publisher: Springer
Release Date : 2016-11-29
Systems Pharmacology And Pharmacodynamics written by Donald E. Mager and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-29 with Medical categories.
While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient. Systems pharmacology is the relatively new discipline that is the interface between these two methods. This book is the first to cover the expertise from systems biology and pharmacodynamics researchers, describing how systems pharmacology may be developed and refined further to show practical applications in drug development. There is a growing awareness that pharmaceutical companies should reduce the high attrition in the pipeline due to insufficient efficacy or toxicity found in proof-of-concept and/or Phase II studies. Systems Pharmacology and Pharmacodynamics discusses the framework for integrating information obtained from understanding physiological/pathological pathways (normal body function system vs. perturbed system due to disease) and pharmacological targets in order to predict clinical efficacy and adverse events through iterations between mathematical modeling and experimentation.
Handbook Of Anticancer Pharmacokinetics And Pharmacodynamics
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Author : Michelle A. Rudek
language : en
Publisher: Springer Science & Business Media
Release Date : 2014-01-10
Handbook Of Anticancer Pharmacokinetics And Pharmacodynamics written by Michelle A. Rudek 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 2014-01-10 with Medical categories.
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
Application Of The Relationship Between Pharmacokinetics And Pharmacodynamics In Drug Development And Therapeutic Equivalence A Pearrl Review
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Author : Ioannis Loisios-Konstantinidis
language : en
Publisher:
Release Date : 2019
Application Of The Relationship Between Pharmacokinetics And Pharmacodynamics In Drug Development And Therapeutic Equivalence A Pearrl Review written by Ioannis Loisios-Konstantinidis and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with categories.
Drug Delivery Approaches
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Author : Bret Berner
language : en
Publisher: John Wiley & Sons
Release Date : 2021-08-31
Drug Delivery Approaches written by Bret Berner 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 2021-08-31 with Medical categories.
Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: A thorough introduction to the utility of mathematical models in drug development and delivery An exploration of the techniques and applications of physiologically based models to drug delivery Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery A review of integrated transdermal delivery and pharmacokinetics in development An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.