Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

CRC Press
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In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip
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About the author

Annpey Pong is a manager in the Department of Biostatistics and Research Decision Sciences at Merck Research Laboratories. Dr. Pong is also the associate editor of the Journal of Biopharmaceutical Statistics. She earned her Ph.D. in statistics from Temple University.

Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke-National University of Singapore Graduate Medical School and the editor of the Journal of Biopharmaceutical Statistics. He earned his Ph.D. in statistics from the University of Wisconsin-Madison.

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Additional Information

Publisher
CRC Press
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Published on
Apr 19, 2016
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Pages
496
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ISBN
9781439810170
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Language
English
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Genres
Mathematics / Probability & Statistics / General
Medical / Pharmacology
Medical / Pharmacy
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Content Protection
This content is DRM protected.
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Available on Android devices
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Eligible for Family Library

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Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "noninformativeness" of the censoring mechanisms relative to the event. Design and Analysis of Clinical Trials with Time-to-Event Endpoints provides a thorough presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest.

After reviewing time-to-event endpoint methodology, clinical trial issues, and the design and monitoring of clinical trials, the book focuses on inferential analysis methods, including parametric, semiparametric, categorical, and Bayesian methods; an alternative to the Cox model for small samples; and estimation and testing for change in hazard. It then presents descriptive and graphical methods useful in the analysis of time-to-event endpoints. The next several chapters explore a variety of clinical trials, from analgesic, antibiotic, and antiviral trials to cardiovascular and cancer prevention, prostate cancer, astrocytoma brain tumor, and chronic myelogonous leukemia trials. The book then covers areas of drug development, medical practice, and safety assessment. It concludes with the design and analysis of clinical trials of animals required by the FDA for new drug applications.

Drawing on the expert contributors’ experiences working in biomedical research and clinical drug development, this comprehensive resource covers an array of time-to-event methods and explores an assortment of real-world applications.

Covering everything you need to study for and pass the Pharmacy Technician Certification Board (PTCB) and ExCPT exams, Mosby's Review for the Pharmacy Technician Certification Examination, 3rd Edition makes exam preparation easy. Review the content you'll see on the exam with handy outlines, test-taking tips and strategies, and electronic flash cards. Written by noted pharmacy technician educator James J. Mizner, this complete review tests your knowledge and simulates the actual PTCB exam with 17 different, 100-question practice exams in the book and online. This edition is modeled after the updated Pharmacy Technician Certification Exam Blueprint.A total of 1,700 review questions are included in 17 practice exams in the book and online.100-question format of each practice exam simulates the PTCB and ExCPT exams, with multiple-choice questions and the same balance of content, for a realistic test taking experience.700 electronic flash cards help you learn and remember facts by covering the top 200 most prescribed pharmaceuticals, top 50 herbals, abbreviations, and sound-alike drugs.Review content reflects the new percentages covered on the PTCB exam.A convenient outline format helps you to quickly review important information you'll see on the exam.Tips and suggestions prepare you for test-taking success by providing an insider’s perspective on what to expect and how to prepare for your exam when you have limited time. Seven practice exams in the book feature the same format and content emphasis as the national exam. Ten practice exams on the Evolve companion website in both timed and untimed modes help you identify any areas of weakness, and include instant feedback and remediation. UPDATED content includes current drug information and pharmacy practice procedures based on the new Pharmacy Technician Certification Exam Blueprint.NEW! Chapter objectives provide a clear breakdown of content and goals for review.
Medicinal chemistry is a complex topic. Written in an easy to follow and conversational style, Basic Concepts in Medicinal Chemistry focuses on the fundamental concepts that govern the discipline of medicinal chemistry as well as how and why these concepts are essential to therapeutic decisions. The book emphasizes functional group analysis and the basics of drug structure evaluation.

In a systematic fashion, learn how to identify and evaluate the functional groups that comprise the structure of a drug molecule and their influences on solubility, absorption, acid/base character, binding interactions, and stereochemical orientation. Relevant Phase I and Phase II metabolic transformations are also discussed for each functional group.

Key features include:
• Discussions on the roles and characteristics of organic functional groups, including the identification of acidic and basic functional groups.
• How to solve problems involving pH, pKa, and ionization; salts and solubility; drug binding interactions; stereochemistry; and drug metabolism.
• Numerous examples and expanded discussions for complex concepts.
• Therapeutic examples that link the importance of medicinal chemistry to pharmacy and healthcare practice.
• An overview of structure activity relationships (SARs) and concepts that govern drug design.
• Review questions and practice problems at the end of each chapter that allow readers to test their understanding, with the answers provided in an appendix.

Whether you are just starting your education toward a career in a healthcare field or need to brush up on your organic chemistry concepts, this book is here to help you navigate medicinal chemistry.

About the Authors

Marc W. Harrold, BS, Pharm, PhD, is Professor of Medicinal Chemistry at the Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA. Professor Harrold is the 2011 winner of the Omicron Delta Kappa "Teacher of the Year" award at Duquesne University. He is also the two-time winner of the "TOPS"  (Teacher of the Pharmacy School) award at the Mylan School of Pharmacy.

Robin M. Zavod, PhD, is Associate Professor for Pharmaceutical Sciences at the Chicago College of Pharmacy, Midwestern University, Downers Grove, IL, where she was awarded the 2012 Outstanding Faculty of the Year award. Professor Zavod also serves on the adjunct faculty for Elmhurst College and the Illinois Institute of Technology. She currently serves as Editor-in-Chief of the journal Currents in Pharmacy Teaching and Learning.

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