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" Drug safety evaluation / "
Shayne Cox Gad.
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BL
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| Record Number
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839985
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| Main Entry
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Gad, Shayne C.,1948-
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| Title & Author
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Drug safety evaluation /\ Shayne Cox Gad.
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| Edition Statement
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Third edition.
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| Publication Statement
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Hoboken, New Jersey :: John Wiley & Sons, Inc.,, [2017]
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| Page. NO
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1 online resource (1 volume)
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| ISBN
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1119097401
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: 111909741X
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: 1119097444
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: 9781119097402
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: 9781119097419
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: 9781119097440
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1119097398
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9781119097396
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9781119097419
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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THE DRUG DEVELOPMENT PROCESS AND THE GLOBAL PHARMACEUTICAL MARKETPLACE -- REGULATION OF HUMAN PHARMACEUTICAL SAFETY -- DATA MINING -- SCREENS IN SAFETY AND HAZARD ASSESSMENT -- FORMULATIONS, ROUTES, AND DOSAGE REGIMENS -- NONCLINICAL MANIFESTATIONS, MECHANISMS, AND END POINTS OF DRUG TOXICITY -- PILOT TOXICITY TESTING IN DRUG SAFETY EVALUATION -- REPEAT-DOSE TOXICITY STUDIES -- GENOTOXICITY -- QSAR TOOLS FOR DRUG SAFETY -- IMMUNOTOXICOLOGY IN DRUG DEVELOPMENT -- NONRODENT ANIMAL STUDIES -- DEVELOPMENTAL AND REPRODUCTIVE TOXICITY TESTING -- CARCINOGENICITY STUDIES -- HISTOPATHOLOGY IN NONCLINICAL PHARMACEUTICAL SAFETY ASSESSMENT -- IRRITATION AND LOCAL TISSUE TOLERANCE IN PHARMACEUTICAL SAFETY ASSESSMENT -- PHARMACOKINETICS AND TOXICOKINETICS IN DRUG SAFETY EVALUATION -- SAFETY PHARMACOLOGY -- SPECIAL CONCERNS FOR THE PRECLINICAL EVALUATION OF BIOTECHNOLOGY PRODUCTS -- SAFETY ASSESSMENT OF INHALANT DRUGS AND DERMAL ROUTE DRUGS -- SPECIAL CASE PRODUCTS -- SPECIAL CASE PRODUCTS -- PEDIATRIC PRODUCT SAFETY ASSESSMENT (2006 GUIDANCE, INCLUDING JUVENILE TOXICOLOGY) -- USE OF IMAGING, IMAGING AGENTS, AND RADIOPHARMACEUTICALS IN NONCLINICAL TOXICOLOGY -- OCCUPATIONAL TOXICOLOGY IN THE PHARMACEUTICAL INDUSTRY -- STRATEGY AND PHASING FOR NONCLINICAL DRUG SAFETY EVALUATION IN THE DISCOVERY AND DEVELOPMENT OF PHARMACEUTICALS -- THE APPLICATION OF IN VITRO TECHNIQUES IN DRUG SAFETY ASSESSMENT -- EVALUATION OF HUMAN TOLERANCE AND SAFETY IN CLINICAL TRIALS -- POSTMARKETING SAFETY EVALUATION -- STATISTICS IN PHARMACEUTICAL SAFETY ASSESSMENT -- COMBINATION PRODUCTS -- QUALIFICATION OF IMPURITIES, DEGRADANTS, RESIDUAL SOLVENTS, METALS, AND LEACHABLES IN PHARMACEUTICALS -- TISSUE, CELL, AND GENE THERAPY -- APPENDIX A: SELECTED REGULATORY AND TOXICOLOGICAL ACRONYMS -- APPENDIX B: DEFINITION OF TERMS AND LEXICON OF "CLINICAL" OBSERVATIONS IN NONCLINICAL (ANIMAL) STUDIES -- APPENDIX C: NOTABLE REGULATORY INTERNET ADDRESSES -- APPENDIX D: GLOSSARY OF TERMS USED IN THE CLINICAL EVALUATION OF THERAPEUTIC AGENTS -- APPENDIX E: COMMON VEHICLES FOR THE NONCLINICAL EVALUATION OF THERAPEUTIC AGENTS -- APPENDIX F: GLOBAL DIRECTORY OF CONTRACT PHARMACEUTICAL TOXICOLOGY LABS -- INDEX.
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| Abstract
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"Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--Provided by publisher.
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| Subject
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Drugs-- Testing.
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Drugs-- Toxicology.
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Drugs-- Testing.
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Drugs-- Toxicology.
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MEDICAL-- Pharmacology.
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Drug Evaluation, Preclinical.
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Drug Evaluation.
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Product Surveillance, Postmarketing.
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| Dewey Classification
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615/.19
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| LC Classification
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RA1238
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| NLM classification
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QV 771G123d 2017
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