Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application

Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application
Title Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application PDF eBook
Author
Publisher
Pages 24
Release 1987
Genre Biopharmaceutics
ISBN

Download Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application Book in PDF, Epub and Kindle

Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application

Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application
Title Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application PDF eBook
Author
Publisher
Pages 15
Release 1987
Genre
ISBN

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Draft Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application

Draft Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application
Title Draft Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application PDF eBook
Author Center for Drugs and Biologics (U.S.)
Publisher
Pages 15
Release 1985
Genre Drugs
ISBN

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Guideline on Formatting, Assembling, and Submitting New Drug and Antibiotic Applications

Guideline on Formatting, Assembling, and Submitting New Drug and Antibiotic Applications
Title Guideline on Formatting, Assembling, and Submitting New Drug and Antibiotic Applications PDF eBook
Author
Publisher
Pages 46
Release 1987
Genre Antibiotics
ISBN

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Insomnia

Insomnia
Title Insomnia PDF eBook
Author Michael J. Sateia
Publisher CRC Press
Pages 498
Release 2016-04-19
Genre Medical
ISBN 1420080806

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The first source on insomnia treatment since the advancement of newer drug options and cognitive behavioral therapies, Insomnia: Diagnosis and Treatment presents a comprehensive reference on the complications, evaluation, and treatment of insomnia. Ideal for sleep medicine specialists, psychiatrists, and neurologists, this text uses a multi-discipl

Topical Drug Bioavailability, Bioequivalence, and Penetration

Topical Drug Bioavailability, Bioequivalence, and Penetration
Title Topical Drug Bioavailability, Bioequivalence, and Penetration PDF eBook
Author Vinod P. Shah
Publisher Springer
Pages 393
Release 2015-01-30
Genre Medical
ISBN 1493912895

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This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.

Oncology Clinical Trials

Oncology Clinical Trials
Title Oncology Clinical Trials PDF eBook
Author William Kevin Kelly, DO
Publisher Springer Publishing Company
Pages 568
Release 2018-03-28
Genre Medical
ISBN 0826168736

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The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included