Download or read book Guideline for the Format and Content of the Chemistry Manufacturing and Controls Section of an Application written by and published by . This book was released on 1987 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline for the Format and Content of the Chemistry Manufacturing and Controls Section of Application written by and published by . This book was released on 1987 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Draft Guideline for the Format and Content of the Chemistry Manufacturing and Controls Section of an Application written by Center for Drugs and Biologics (U.S.) and published by . This book was released on 1985 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline on Formatting Assembling and Submitting New Drug and Antibiotic Applications written by DIANE Publishing Company and published by DIANE Publishing. This book was released on 1998-04 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline on Formatting Assembling and Submitting New Drug and Antibiotic Applications written by and published by . This book was released on 1987 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register written by and published by . This book was released on 1982-10-19 with total page 1366 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by John Wiley & Sons. This book was released on 2008-12-04 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.
Download or read book NIDA Research Monograph written by and published by . This book was released on 1976 with total page 936 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pacific Yew Draft Environmental Impact Statement appendices written by and published by . This book was released on 1993 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: Item no. 0080-F.
Download or read book Pacific Yew CA ID OR WA written by and published by . This book was released on 1993 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pacific Yew Appendices B O written by and published by . This book was released on 1993 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Comprehensive Biotechnology written by and published by Elsevier. This book was released on 2019-07-17 with total page 4876 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive Biotechnology, Third Edition, Six Volume Set unifies, in a single source, a huge amount of information in this growing field. The book covers scientific fundamentals, along with engineering considerations and applications in industry, agriculture, medicine, the environment and socio-economics, including the related government regulatory overviews. This new edition builds on the solid basis provided by previous editions, incorporating all recent advances in the field since the second edition was published in 2011. Offers researchers a one-stop shop for information on the subject of biotechnology Provides in-depth treatment of relevant topics from recognized authorities, including the contributions of a Nobel laureate Presents the perspective of researchers in different fields, such as biochemistry, agriculture, engineering, biomedicine and environmental science
Download or read book Drug Development written by Charles E. Hamner and published by CRC Press. This book was released on 2019-06-12 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.
Download or read book New Drug Development written by Mark P. Mathieu and published by Parexel International Corporation. This book was released on 1997 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book AIDS in Asia written by Yichen Lu and published by Springer Science & Business Media. This book was released on 2004-06-01 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: Asia has become the new battle ground for the war against HIV/AIDS. The magnitude of the potential public health problems caused by AIDS in this populous continent may become a catastrophic disaster. A 10% rate of prevalence of HIV-1 in India and China alone would mean more than 200 million people are infected with HIV. AIDS in Asia is useful as a comprehensive, up-to-date AIDS reference book for public health and medical professionals. This volume provides concrete information on the diagnosis, treatment, care, prevention and impact of AIDS. Part I contains 'Snapshots of HIV/AIDS in Asia.' Countries and regions included in this section are: Thailand, India, China, Japan, Vietnam, Laos, Cambodia, Myanmar, Malaysia, Indonesia, the Philippines, Pakistan, Nepal, Sri Lanka, Hawaii and the Pacific Islands, Hong Kong and Taiwan. Part II addresses the molecular epidemiology of HIV/AIDS. Part III deals with the diagnosis, surveillance and projected scenarios of the AIDS epidemic. Part IV outlines prevention efforts and treatment options. Part V provides an overview of the ongoing collaborative efforts involved in several different nations in the worldwide war against AIDS. This volume will be invaluable to all the public health professionals and researchers working in this field. "...the book is a useful addition to the HIV/AIDS literature." "AIDS in Asia offers a comprehensive, interesting overview of the epidemic there and of general issues that will influence its progression." -Roger Detels, MD, MS, University of California-Los Angeles The Journal of the American Medical Association, Book Review, 293:15
Download or read book Handbook of Modern Pharmaceutical Analysis written by Satinder Ahuja and published by Academic Press. This book was released on 2001 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.
Download or read book Monthly Catalogue United States Public Documents written by and published by . This book was released on 1987 with total page 1108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
