عنوان

Drug safety evaluation /

شابک

1119097401

شابک

111909741X

شابک

1119097444

شابک

9781119097402

شابک

9781119097419

شابک

9781119097440

شابک اشتباه

1119097398

شابک اشتباه

9781119097396

شابک اشتباه

9781119097419

شماره ناشر

EB00692474

منبع

Recorded Books

عنوان اصلي

Drug safety evaluation /

نام عام مواد

[Book]

نام نخستين پديدآور

Shayne Cox Gad.

وضعيت ويراست

Third edition.

محل نشرو پخش و غیره

Hoboken, New Jersey :

نام ناشر، پخش کننده و غيره

John Wiley & Sons, Inc.,

تاریخ نشرو بخش و غیره

[2017]

نام خاص و کميت اثر

1 online resource (1 volume)

متن يادداشت

Includes bibliographical references and index.

متن يادداشت

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.

بدون عنوان

0

متن يادداشت

"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.

عنوان

Drug safety evaluation.

شماره استاندارد بين المللي کتاب و موسيقي

9781119097396

موضوع مستند نشده

Drugs-- Testing.

موضوع مستند نشده

Drugs-- Toxicology.

موضوع مستند نشده

Drug Evaluation, Preclinical.

موضوع مستند نشده

Drug Evaluation.

موضوع مستند نشده

Product Surveillance, Postmarketing.

موضوع مستند نشده

Drugs-- Testing.

موضوع مستند نشده

Drugs-- Toxicology.

موضوع مستند نشده

MEDICAL-- Pharmacology.

موضوع مستند نشده

MED-- 071000

شماره

ويراست

شماره رده

شماره رده

نشانه اثر

مستند نام اشخاص تاييد نشده

Gad, Shayne C.,1948-

تاريخ عمليات

20200822152341.0

قواعد فهرست نويسي ( بخش توصيفي )

pn

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y