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A dictionary of pharmacology and clinical drug evaluation
Authors: ---
ISBN: 1857281136 1857281128 Year: 1994 Publisher: London : UCL Press,

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Post-authorization safety studies of medicinal products : the PASS book
Authors: ---
ISBN: 0128092084 0128092173 9780128092088 9780128092170 Year: 2018 Publisher: London, United Kingdom : Academic Press,

Against the odds : the story of AIDS drug development, politics, and profits
Authors: ---
ISBN: 0060183098 Year: 1992 Publisher: New York HarperCollins

Drug discovery and design : medical aspects
Authors: ---
ISBN: 1280505532 9786610505531 6000004036 1601294204 058545891X 9780585458915 9781601294203 9781586032616 1586032615 9784274905223 4274905225 Year: 2002 Publisher: Amsterdam ; Washington, D.C. : Tokyo : IOS Press ; Ohmsha,

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This work covers review articles and research articles related to the ""Bioactive Drugs in Drug Discovery Design"". It covers the synthesis and properties of bioactive molecules and enzymes, the role of membranes in drug activity and formulation.


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Drugs and laboratory parameters
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ISBN: 8889688556 9788889688557 9788889688953 Year: 2010 Publisher: Torino : SEEd,

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Aim of this easy-to-read book is to help physicians in the routine interpretation of laboratory results, drawing their attention to the possibility that abnormal laboratory results may be drug-related. The book describes the most common variations (increase/decrease) of blood parameters that can be caused by drugs intake.


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The Alzheimer's Disease Challenge
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Year: 2019 Publisher: Frontiers Media SA

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This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact


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The Alzheimer's Disease Challenge
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Year: 2019 Publisher: Frontiers Media SA

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This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact


Book
The Alzheimer's Disease Challenge
Authors: --- ---
Year: 2019 Publisher: Frontiers Media SA

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This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact

Statistical Monitoring of Clinical Trials : A Unified Approach
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ISBN: 1280724196 9786610724192 0387449701 0387300597 1441921346 Year: 2006 Publisher: New York, NY : Springer New York : Imprint: Springer,

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The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion (``the B-value") irrespective of the test statistic. The so-called B-value approach to monitoring allows us to use, for different types of trials, the same boundaries and the same simple formula for computing conditional power. Although Brownian motion may sound complicated, the authors make the approach easy by starting with a simple example and building on it, one piece at a time, ultimately showing that Brownian motion works for many different types of clinical trials. The book will be very valuable to statisticians involved in clinical trials. The main body of the chapters is accessible to anyone with knowledge of a standard mathematical statistics text. More mathematically advanced readers will find rigorous developments in appendices at the end of chapters. Reading the book will develop insight into not only monitoring, but power, survival analysis, safety, and other statistical issues germane to clinical trials. Michael Proschan, Gordon Lan, and Janet Wittes are elected Fellows of the American Statistical Association. All have spent formative years in the Biostatistics Research Branch of the National Heart, Lung, and Blood Institute (NHLBI/NIH). While there, they were intimately involved in the design and statistical monitoring of large-scale randomized clinical trials, developing methodology to aid in their monitoring. For example, Lan developed, with DeMets, the now widely-used spending function approach to group sequential designs, whose properties were further investigated by Proschan. The B-value approach used in the book was introduced in a very influential paper by Lan and Wittes. The statistical theory behind conditional power was developed by Lan, along with Simon and Halperin, and was the cornerstone for the conditional error approach to adaptive clinical trials introduced by Proschan and Hunsberger. All three authors have expertise in adaptive methodology for clinical trials. Michael Proschan is a Mathematical Statistician at the National Institutes of Health; Gordon Lan is Senior Director of Biometrics at Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Janet Wittes is President of Statistics Collaborative, a statistical consulting company she founded in 1990.


Book
Bioequivalence Requirements in Various Global Jurisdictions
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ISBN: 3319680781 3319680773 Year: 2017 Publisher: Cham : Springer International Publishing : Imprint: Springer,

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Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various  BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.

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