Download or read book The Clinical Evaluation of New Drugs written by Sholom Omi Waife and published by . This book was released on 1959 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Arzneimittel / Test / Klinik.

Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Clinical Evaluation of New Drugs Fourteen Authors written by S. O Waife and published by . This book was released on 1959 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book General Considerations for the Clinical Evaluation of Drugs in Infants and Children written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Principles for the Clinical Evaluation of Drugs written by World Health Organisation. Scientific Group on Principles for the Clinical Evaluation of Drugs and published by . This book was released on 1968 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book General Considerations for the Clinical Evaluation of Drugs in Infants and Children written by United States. Food and Drug Administration and published by . This book was released on 1977 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Principles for the Clinical Evaluation of Drugs written by World Health Organization. Scientific Group on Principles for the Clinical Evaluation of Drugs and published by . This book was released on 1968 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guidelines established by the World Health Organization Scientific Group on Principles for the Clinical Evaluation of Drugs (Geneva, 1967) are summarized. Clinical introduction of druggs developed from work with laboratory animals should be preceded by carefully planned human investigations within several scientific disciplines including biochemistry, pharmacology and toxicology, clinical pharmacology, clinical medicine, and medical statistics. Formal therapeutic trial should begin only after an initial therapeutic potential has been established through close study of a few individuals. Improved human evaluation of drugs requires better laboratory facilities and more highly trained personnel and might be achieved by the creation of more clinical pharmacology units within medical centers. Future emphasis should be placed on developing better techniques for measuring absorption, distribution, and excretion of drugs and their metabolites, and for accurate detection of toxic effects. The ethical and technical complexities of drug evaluation require thorough planning discussions with a local medical and scientific committee, rather than an official control organization, before initial investigation is begun. Methods should be established for compensating subjects suffering ill health or injury during the course of experimentation, even where there is no question of legal liability for negligence. Prompt dissemination of all relevant information concerning new drugs should be included as an integral part of every investigation. Monitoring of adverse reactions to drugs in widespread use requires extensive, additional research which should focus on the elaboration of methods that will provide early warning of drug-related toxicity as well as incidence figures that can be used to quantify associated risks.

Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guidelines for the Clinical Evaluation of Antidepressant Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guidelines for the Clinical Evaluation of Hypnotic Drugs written by United States. Food and Drug Administration and published by . This book was released on 1977 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guidelines for the Clinical Evaluation of Antianxiety Drugs written by United States. Food and Drug Administration and published by . This book was released on 1977 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guidelines for the Clinical Evaluation of Antineoplastic Drugs written by and published by . This book was released on 1981 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Principles for the Clinical Evaluation of Drugs Report of a W H O Scientific Group written by World Health Organization. Scientific Group on Principles for the Clinical Evaluation of Drugs and published by . This book was released on 1968 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guidelines for Clinical Evaluation of New Drugs written by and published by . This book was released on 1986 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-18 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition