Developmental Pharmacology And Therapeutics

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Safe and Effective Medicines for Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Rational Therapeutics for Infants and Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309069378
Total Pages : 135 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Rational Therapeutics for Infants and Children by : Institute of Medicine

Download or read book Rational Therapeutics for Infants and Children written by Institute of Medicine and published by National Academies Press. This book was released on 2000-05-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

Proceedings of the ... congress of the European Society for Developmental Pharmacology

Author : European Society for Developmental Pharmacology
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (748 download)

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Book Synopsis Proceedings of the ... congress of the European Society for Developmental Pharmacology by : European Society for Developmental Pharmacology

Download or read book Proceedings of the ... congress of the European Society for Developmental Pharmacology written by European Society for Developmental Pharmacology and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Proceedings of the First Congress of the European Society for Developmental Pharmacology

Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (551 download)

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Book Synopsis Proceedings of the First Congress of the European Society for Developmental Pharmacology by :

Download or read book Proceedings of the First Congress of the European Society for Developmental Pharmacology written by and published by . This book was released on 1989 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Proceedings of the Second Congress of the European Society for Developmental Pharmacology

Author : European Society for Developmental Pharmacology
Publisher :
ISBN 13 :
Total Pages : 109 pages
Book Rating : 4.:/5 (831 download)

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Book Synopsis Proceedings of the Second Congress of the European Society for Developmental Pharmacology by : European Society for Developmental Pharmacology

Download or read book Proceedings of the Second Congress of the European Society for Developmental Pharmacology written by European Society for Developmental Pharmacology and published by . This book was released on 1990 with total page 109 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pediatric Drug Development

Author : Andrew E. Mulberg
Publisher : John Wiley & Sons
ISBN 13 : 1118312058
Total Pages : 782 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Pediatric Drug Development by : Andrew E. Mulberg

Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2013-05-20 with total page 782 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.

Rational Therapeutics for Infants and Children

Author : Roundtable on Research and Development of Drugs Biologics and Medical Devices
Publisher :
ISBN 13 : 9780309382700
Total Pages : 136 pages
Book Rating : 4.3/5 (827 download)

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Book Synopsis Rational Therapeutics for Infants and Children by : Roundtable on Research and Development of Drugs Biologics and Medical Devices

Download or read book Rational Therapeutics for Infants and Children written by Roundtable on Research and Development of Drugs Biologics and Medical Devices and published by . This book was released on 2000-04-07 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

Neonatal and Pediatric Pharmacology

Author : Sumner J. Yaffe
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 0781795389
Total Pages : 1072 pages
Book Rating : 4.7/5 (817 download)

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Book Synopsis Neonatal and Pediatric Pharmacology by : Sumner J. Yaffe

Download or read book Neonatal and Pediatric Pharmacology written by Sumner J. Yaffe and published by Lippincott Williams & Wilkins. This book was released on 2011 with total page 1072 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Neonatal and Pediatric Pharmacology offers guidelines for safe, effective, and rational drug therapy in newborns, children and adolescents. The book provides relevant and useful data on the molecular, physiologic, biochemical, and pharmacologic mechanisms of drug action and therapy in this population. The authors identify areas of innovative basic and translational research necessary for the continuing evaluation and development of drugs for the fetus, newborns, children and adolescents. Neonatal and Pediatric Pharmacology is is a valuable reference for all health care professionals who treat the fetus, newborns, children, and adolescents, including neonatologists, nurses, pediatricians, general practitioners, students, obstetricians, perinatologists, surgeons and allied health professionals. It will be useful anytime during the day and especially in the middle of the night when knowledge of appropriate indications, safe and effective use, dosage, and therapeutic regimen for a certain drug or molecular entity is immediately needed. The book is also directed to those involved in basic, clinical, and other academic pharmacological research, the pharmaceutical industry, and regulatory agencies dealing with drug and therapeutic developments for this population. Those teaching pharmacology and therapeutics will find this compilation of information extremely useful in preparing teaching materials"--Provided by publisher.

Pediatric Clinical Pharmacology

Author : Hannsjörg W. Seyberth
Publisher : Springer Science & Business Media
ISBN 13 : 3642201954
Total Pages : 385 pages
Book Rating : 4.6/5 (422 download)

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Book Synopsis Pediatric Clinical Pharmacology by : Hannsjörg W. Seyberth

Download or read book Pediatric Clinical Pharmacology written by Hannsjörg W. Seyberth and published by Springer Science & Business Media. This book was released on 2011-09-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of this volume is to give an overview of the present state of the art of pediatric clinical pharmacology including developmental physiology, pediatric-specific pathology, special tools and methods for development of drugs for children (assessment of efficacy, toxicity, long-term safety etc.) as well as regulatory and ethical knowledge and skills. In the future, structural and educational changes have to lead back to a closer cooperation and interaction of pediatrics with (clinical) pharmacology and pharmacy.

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins

Author : Honghui Zhou
Publisher : John Wiley & Sons
ISBN 13 : 111889880X
Total Pages : 472 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins by : Honghui Zhou

Download or read book ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2015-10-26 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain

Addressing the Barriers to Pediatric Drug Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309178657
Total Pages : 64 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Addressing the Barriers to Pediatric Drug Development by : Institute of Medicine

Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

Principles of Clinical Pharmacology

Author : Arthur J. Atkinson, Jr.
Publisher : Academic Press
ISBN 13 : 0123854725
Total Pages : 652 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis Principles of Clinical Pharmacology by : Arthur J. Atkinson, Jr.

Download or read book Principles of Clinical Pharmacology written by Arthur J. Atkinson, Jr. and published by Academic Press. This book was released on 2012-09-18 with total page 652 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Clinical Pharmacology is a successful survey covering the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This essential reference continues to focus on the basics of clinical pharmacology for the development, evaluation, and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the third edition has been thoroughly updated to provide readers with an ideal reference covering the wide range of important topics impacting clinical pharmacology as the discipline plays an increasingly significant role in drug development and regulatory science. The Third Edition has been endorsed by the American Society for Clinical Pharmacology and Therapeutics Includes new chapters on imaging and the pharmacogenetic basis of adverse drug reactions Offers an expanded regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers and also illustrates the impact of gender on drug response Presents a broadened discussion of clinical trials from Phase 1 to incorporate Phases II and III

Pharmacokinetics and Pharmacodynamics of Biotech Drugs

Author : Bernd Meibohm
Publisher : John Wiley & Sons
ISBN 13 : 3527609520
Total Pages : 426 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Pharmacokinetics and Pharmacodynamics of Biotech Drugs by : Bernd Meibohm

Download or read book Pharmacokinetics and Pharmacodynamics of Biotech Drugs written by Bernd Meibohm and published by John Wiley & Sons. This book was released on 2006-12-13 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Rare Diseases and Orphan Products

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)

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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 118 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.

Atkinson's Principles of Clinical Pharmacology

Author : Shiew-Mei Huang
Publisher : Academic Press
ISBN 13 : 0128198842
Total Pages : 764 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Atkinson's Principles of Clinical Pharmacology by : Shiew-Mei Huang

Download or read book Atkinson's Principles of Clinical Pharmacology written by Shiew-Mei Huang and published by Academic Press. This book was released on 2021-10-16 with total page 764 pages. Available in PDF, EPUB and Kindle. Book excerpt: Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK

Clinical Pharmacology and Therapeutics

Author : Gerard A. McKay
Publisher : John Wiley & Sons
ISBN 13 : 1119599954
Total Pages : 313 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Clinical Pharmacology and Therapeutics by : Gerard A. McKay

Download or read book Clinical Pharmacology and Therapeutics written by Gerard A. McKay and published by John Wiley & Sons. This book was released on 2021-01-26 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have companion for medical students and junior doctors for almost four decades, Lecture Notes: Clinical Pharmacology and Therapeutics provides concise yet thorough coverage of the principles of clinical pharmacology, the major characteristics of therapeutics, and the practical aspects of prescribing drugs to alleviate symptoms and to treat disease. Whether you are preparing for examinations or prescribing to patients, the tenth edition offers readers current and authoritative insight into the essential practical and clinical knowledge. Logically organised chapters allow for rapid location of key information, while examples of commonly encountered scenarios illustrate how and when to use drugs in clinical situations. Throughout the text, practice questions, prescribing guidelines, and self-assessment tests clarify and reinforce the principles that inform appropriate clinical decision-making. Presents an up-to-date review of drug use across all major clinical disciplines Offers a timely overview of clinical drug trials and development Provides new clinical scenarios to relate chapter content to real-life application Contains colour-coded “Key Points” and “Prescribing Points” to highlight important information Includes chapter introductions and summaries, and numerous figures, tables, and colour illustrations Lecture Notes: Clinical Pharmacology and Therapeutics, Tenth Edition, is an essential resource for medical students, junior doctors, and other prescribers looking for an up-to-date reference on pharmacological principles, prescribing, and therapeutics.