Drugs On Trial
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Drugs On Trial
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Author : Andreas-Holger Maehle
language : en
Publisher: BRILL
Release Date : 2016-08-29
Drugs On Trial written by Andreas-Holger Maehle and has been published by BRILL this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-29 with Medical categories.
This book describes the main issues of eighteenth-century pharmacology and therapeutics and provides detailed case studies of three key areas: lithontriptics (remedies against urinary stones), opium, and Peruvian bark (quinine).
Clinical Drug Trials And Tribulations Revised And Expanded Second Edition
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Author : Allen Cato
language : en
Publisher: CRC Press
Release Date : 2002-03-26
Clinical Drug Trials And Tribulations Revised And Expanded Second Edition written by Allen Cato and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-03-26 with Medical categories.
Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.
Medical Drugs On Trial Verdict Guilty
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Author : Keki R. Sidhwa
language : en
Publisher:
Release Date : 1976
Medical Drugs On Trial Verdict Guilty written by Keki R. Sidhwa and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1976 with Drugs categories.
Drugs On Trial
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Author :
language : en
Publisher:
Release Date : 1999
Drugs On Trial written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999 with categories.
Printbegrænsninger: Der kan printes kapitelvis
Good Practice Of Clinical Drug Trials
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Author : Alain Spriet
language : en
Publisher: S. Karger AG (Switzerland)
Release Date : 1997
Good Practice Of Clinical Drug Trials written by Alain Spriet and has been published by S. Karger AG (Switzerland) this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Medical categories.
The success of any new pharmaceutical product depends on the clinical drug trial to give clear scientific proof of efficacy and safety. Only sufficient quality-control guarantees international acceptance of study results. This revised edition takes into account the most recent regulation changes made in inspection of clinical trials. Some chapters have been rewritten, such as "monitoring a clinical trial" and "data management", in order to develop the concepts of source-documents and coding.
Clinical Drug Trials And Tribulations Revised And Expanded Second Edition
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Author : Allen Cato
language : en
Publisher: CRC Press
Release Date : 2002-03-26
Clinical Drug Trials And Tribulations Revised And Expanded Second Edition written by Allen Cato and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-03-26 with Medical categories.
Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.
The Prevention And Treatment Of Missing Data In Clinical Trials
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2010-12-21
The Prevention And Treatment Of Missing Data In Clinical Trials written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-21 with Medical categories.
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Clinical Drug Trials
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Author : Valérie Junod
language : en
Publisher:
Release Date : 2005
Clinical Drug Trials written by Valérie Junod and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Drugs categories.
Clinical Trials
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Author : Tom Brody
language : en
Publisher: Academic Press
Release Date : 2016-02-19
Clinical Trials written by Tom Brody and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-02-19 with Medical categories.
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Clinical Trials Of Drugs And Biopharmaceuticals
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Author : Chi-Jen Lee
language : en
Publisher: CRC Press
Release Date : 2005-09-19
Clinical Trials Of Drugs And Biopharmaceuticals written by Chi-Jen Lee and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-09-19 with Medical categories.
The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an