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Author: H.Gerhard Vogel
Publisher: Springer Science & Business Media
ISBN: 3540898905
Category : Medical
Languages : en
Pages : 576
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Book Description
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
Author: H.Gerhard Vogel
Publisher: Springer Science & Business Media
ISBN: 3540898905
Category : Medical
Languages : en
Pages : 576
Get Book Here
Book Description
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
Author: Barry G. Woodcock
Publisher:
ISBN:
Category :
Languages : en
Pages : 351
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Book Description
Author: Olivia Hodges
Publisher:
ISBN: 9781684692460
Category :
Languages : en
Pages :
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Book Description
Author: Norbert Rietbrock
Publisher: Vieweg+teubner Verlag
ISBN:
Category : Medical
Languages : de
Pages : 354
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Book Description
"We pharmacologists must acquire a knowledge of the tools we use . . . Fortunately a surgeon who uses the wrong side of a scalpel cuts his own fingers and not the patient; if the same applied to drugs they would have been investigated very carefully a long time ago . . . More ceterum censeo is perhaps necessary in order to rouse pharmacology from its sleep. The sleep is not a natural one since pharma cology, as judged by its past accomplishments, has no reason for being tired. " From R. Buchheim Beiträge zur Arzneimittel/ehre, Voss, Leipzig, 1849. Chapter 1 Preface and introduction Methods, clinical pharrnacology and the clinical pharmacologist In this book are brought together the proceedings from lecures and poster-demonstrations at the International Symposium on Methods in Clinical Pharmacology held in Frankfurt, May 6th-8th 1979. The symposium provided a forum for a group of invited clinical pharmacologist to speak on a topic of their own selection. They were asked to place special emphasis on the methodological aspects of their work they considered to be important. Seventeen of the speakers came from overseas. The sym posium was thus an attempt to establish a methodological basis for further advancements in clinical pharmacology. This book, we hope, will be recognised as documentary evidence that this has been done. Owing to the considerable advancements that have been achieved, it may be forgotten or not realised that clinical pharmacology is a relativelyyoung discipline (7 to 10 years at the most).
Author: Malcolm Harold Lader
Publisher: Palgrave Macmillan
ISBN: 9781349060405
Category : Medical
Languages : en
Pages : 0
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Book Description
Author: Shiew-Mei Huang
Publisher: Academic Press
ISBN: 0128198842
Category : Medical
Languages : en
Pages : 764
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Book Description
**Selected for Doody's Core Titles® 2024 in Pharmacology**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
Author: H.Gerhard Vogel
Publisher: Springer
ISBN: 9783642277306
Category : Medical
Languages : en
Pages : 564
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Book Description
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
Author: Scott D. Patterson
Publisher: CRC Press
ISBN: 1466585218
Category : Mathematics
Languages : en
Pages : 434
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Book Description
Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.
Author: H. Gerhard Vogel
Publisher: Springer
ISBN: 9783540334422
Category : Medical
Languages : en
Pages : 889
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Book Description
This book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs. The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process. In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide.
Author: Rietbrock Norbert
Publisher: Springer-Verlag
ISBN: 3322897281
Category : Medical
Languages : de
Pages : 158
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Book Description
