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Periodical
"Drug Design, Development and Therapy"
ISSN: 11778881

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Periodical
Pharmacogenomics and Personalized Medicine
ISSN: 11787066

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Statistical issues in drug development
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ISBN: 0471974889 9780471974888 Year: 1999 Publisher: Chichester: Wiley,

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Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:* Human and Biological Sciences* Earth and Environmental Sciences* Industry, Commerce and FinanceStatistical Issues in Drug Development Stephen Senn Professor of Pharmaceutical & Health Statistics, University College, London Statistical Issues in Drug Development provides an accessible text for those working directly in drug development, regulatory and marketing departments within the pharmaceutical industry. As a consequence of regulatory authorities demanding increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programmes. The concepts covered in this volume guide the non-statistician through the most pressing statistical issues and controversies in drug development. Key issues covered include:* Design & interpretation of clinical trials* Bayesian & frequentist methods* Sequential & cross-over trials* Drug monitoring & pharmaco-economicsThe book has been prepared in two sections. The first section considers the role of statistics in drug development from four different perspectives: historical, philosophical, technical and professional. The second section covers a series of controversial topics such as fixed versus random effects for meta-analysis, one-sided versus two-sided tests and the ethics of placebo run-ins. The approachable and wide-ranging coverage of this book will make it invaluable to all those working in drug development and regulation.

Methods in plant electron microscopy and cytochemistry
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ISBN: 0896035891 Year: 2000 Publisher: Totowa, N.J. Humana Press


Periodical
DARU journal of pharmaceutical sciences.
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ISSN: 15608115 20082231 Year: 2012 Publisher: London : BioMed Central,


Periodical
International journal of high throughput screening.
ISSN: 11791381 Year: 2010 Publisher: Auckland, NZ : Dove Medical Press

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Keywords

High throughput screening (Drug development) --- Drug Design. --- Drug Evaluation, Preclinical. --- Chemistry, Pharmaceutical. --- Chemistry, Pharmaceutic --- Pharmaceutic Chemistry --- Pharmaceutical Chemistry --- Medicinal Chemistry --- Chemistry, Medicinal --- Drug Evaluation Studies, Preclinical --- Drug Evaluations, Preclinical --- Evaluation Studies, Drug, Preclinical --- Evaluation, Preclinical Drug --- Evaluations, Preclinical Drug --- Medicinal Plants Testing, Preclinical --- Preclinical Drug Evaluation --- Preclinical Drug Evaluations --- Drug Screening --- Evaluation Studies, Drug, Pre-Clinical --- Drug Screenings --- Screening, Drug --- Screenings, Drug --- Drug Modeling --- Design, Drug --- Designs, Drug --- Drug Designs --- Drug Modelings --- Modeling, Drug --- Modelings, Drug --- High throughput testing (Drug development) --- HRS (Drug development) --- Pharmacy. --- Drug development --- Pharmaceutical chemistry --- Drug Design --- Drug Evaluation, Preclinical --- Chemistry, Pharmaceutical --- Computer-Aided Drug Design --- Computerized Drug Design --- Pharmaceutical Design --- Computer Aided Drug Design --- Computer-Aided Drug Designs --- Computerized Drug Designs --- Design, Computer-Aided Drug --- Design, Computerized Drug --- Design, Pharmaceutical --- Designs, Computer-Aided Drug --- Designs, Computerized Drug --- Designs, Pharmaceutical --- Drug Design, Computer-Aided --- Drug Design, Computerized --- Drug Designs, Computer-Aided --- Drug Designs, Computerized --- Pharmaceutical Designs --- Pharmacy, Therapeutics, & Pharmacology

Dose finding in drug development
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ISBN: 1280726644 9786610726646 0387337067 0387290745 144192115X 9780387290744 Year: 2006 Publisher: New York, N.Y. Springer

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When you go to the pharmacy and fill a prescription, have you ever wondered if the dose of the medication is right for you? Can the dose be too low so that the drug will not work? Can the dose be too high that it may cause some potential problem? How do people learn about dosing information? This book answers some of these questions. Dosing information on the drug label is based on discussion and agreement between the pharmaceutical manufacturer and the drug regulatory agency. A drug label is a high level summary of results obtained from many scientific experiments. Scientists with biological, chemical, medical, or statistical background working in the pharmaceutical industry designed and executed these experiments to obtain information to help understand the dosing information. This book introduces the drug development process, the design and analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Although the book is prepared mainly for statisticians/biostatisticians, it also serves as a useful reference to a variety of professionals working for the pharmaceutical industry. The potential readers include pharmacokienticists, clinical scientists, clinical pharmacologists, pharmacists, project managers, pharmaceutical scientists, clinicians, programmers, data managers, regulatory specialists, and study report writers. This book is also a good reference for professionals working in a drug regulatory environment, for example, the FDA. Scientists and/or reviewers from both U.S. and foreign drug regulatory agencies can benefit greatly from this book. In addition, statistical and medical professionals in academia may find this book helpful in understanding the drug development process and practical concerns in selecting doses for a new drug. Naitee Ting received his Ph. D. in statistics from Colorado State University in 1987 and joined Pfizer Research right after obtaining his Ph. D. Dr. Ting is currently an Associate Director of Biostatistics in Pfizer Global Research and Development, supporting clinical development of new drugs. He has over 18 years of experiences in designing and analyzing late phase clinical trials. During his tenure at Pfizer, Dr. Ting has published more than 20 statistical papers in peer-reviewed journals and book chapters. He has also taught clinical trials courses at the University of Connecticut and University of Rhode Island.


Periodical
Drug discovery today.
ISSN: 17406749 Year: 2004 Publisher: [Oxford] : Elsevier,

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Keywords

Molecular biology --- Toxicology --- Technology, Pharmaceutical --- Drug Design --- Drug development --- Physiology, Pathological --- Drugs --- Médicaments --- Physiopathologie --- trends --- Periodicals. --- Design --- Développement --- Périodiques --- Conception --- Drug Design. --- Drug development. --- Physiology, Pathological. --- trends. --- Design. --- Clinical physiology --- Pathological physiology --- Pathophysiology --- Physiopathology --- Drug design --- Pharmaceutical design --- Development of drugs --- New drug development --- Drug Modeling --- Design, Drug --- Designs, Drug --- Drug Designs --- Drug Modelings --- Modeling, Drug --- Modelings, Drug --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Development --- Pathology --- Physiology --- Pharmacology --- Pharmacy --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Computer-Aided Drug Design --- Computerized Drug Design --- Pharmaceutical Design --- Computer Aided Drug Design --- Computer-Aided Drug Designs --- Computerized Drug Designs --- Design, Computer-Aided Drug --- Design, Computerized Drug --- Design, Pharmaceutical --- Designs, Computer-Aided Drug --- Designs, Computerized Drug --- Designs, Pharmaceutical --- Drug Design, Computer-Aided --- Drug Design, Computerized --- Drug Designs, Computer-Aided --- Drug Designs, Computerized --- Pharmaceutical Designs --- farmacologie --- toxicologie --- moleculaire biologie --- Pharmacy, Therapeutics, & Pharmacology

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