Drug safety evaluation

"This new edition of Drug Safety Evaluation presents an all-inclusive practical guide for those who are responsible for developing new drugs and ensuring the safety of an ever-expanding spectrum of therapeutics. This book helps readers understand how the safety of these products are evaluated f...

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Bibliographic Details
Main Authors: Gad, Shayne C., 1948- (Author), Sullivan, Dexter W., Jr., (Author)
Format: eBook
Language: English
Published: Hoboken, NJ : John Wiley & Sons, Inc., 2023.
Edition: Fourth edition.
Subjects:
Drugs > Toxicology.
Drugs > Testing.
Pharmacovigilance.
Drugs > Side effects > Reporting.
Drug monitoring.
elektronické knihy
electronic books
ISBN: 9781119755883
9781119755876
1119755875
9781119755869
1119755867
1119755883
9781119755852
Physical Description: 1 online resource (xxxi, 960 pages) : illustrations

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Table of contents

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001 kn-on1350644621
003 OCoLC
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006 m o d
007 cr cn|||||||||
008 220906t20232023njua ob 001 0 eng
040 |a DLC  |b eng  |e rda  |c DLC  |d YDX  |d DG1  |d OCLCQ  |d UCW  |d UPM  |d OCLCF  |d UKMGB  |d OCLCQ  |d OCLCO  |d OCLCL 
020 |a 9781119755883  |q (electronic bk. : oBook) 
020 |a 9781119755876  |q electronic book 
020 |a 1119755875  |q electronic book 
020 |a 9781119755869  |q electronic book 
020 |a 1119755867  |q electronic book 
020 |a 1119755883  |q electronic book 
020 |z 9781119755852  |q hardcover 
024 7 |a 10.1002/9781119755883  |2 doi 
035 |a (OCoLC)1350644621  |z (OCoLC)1381119872 
042 |a pcc 
100 1 |a Gad, Shayne C.,  |d 1948-  |e author. 
245 1 0 |a Drug safety evaluation /  |c Shayne Cox Gad, Dexter W. Sullivan, Jr. 
250 |a Fourth edition. 
264 1 |a Hoboken, NJ :  |b John Wiley & Sons, Inc.,  |c 2023. 
264 4 |c ©2023 
300 |a 1 online resource (xxxi, 960 pages) :  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
505 0 0 |t The Drug Development Process and the Global Pharmaceutical Marketplace --  |t Regulation of Human Pharmaceutical Safety : Routes to Human Use and Market --  |t Data Mining : Sources of Information for Consideration in Study and Program Design and in Safety Evaluation --  |t Electronic Records, Reporting, and Submission : eCTD and Send --  |t Screens in Safety and Hazard Assessment --  |t Formulations, Routes, and Dosage Regimens --  |t Mechanisms and End Points of Drug Toxicity --  |t Pilot Toxicity Testing in Drug Safety Evaluation : MTD and DRF --  |t Repeat­Dose Toxicity Studies --  |t Genotoxicity --  |t QSAR Tools for Drug Safety --  |t Toxicogenomics --  |t Immunotoxicology in Drug Development --  |t Nonrodent Animal Studies --  |t Developmental and Reproductive Toxicity Testing --  |t Carcinogenicity Studies --  |t Histopathology and Clinical Pathology in Nonclinical Pharmaceutical Safety Assessment --  |t Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment --  |t Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation --  |t Safety Pharmacology --  |t Special Concerns for the Preclinical Evaluation of Biotechnology Products --  |t Safety Assessment of Inhalant Drugs and Dermal Route Drugs --  |t Special Case Products : Imaging Agents --  |t Special Case Products : Drugs for Treatment of Cancer --  |t Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile and Pediatric Toxicology) --  |t Use of Imaging, Imaging Agents, and Radiopharmaceuticals in Nonclinical Toxicology --  |t Occupational Toxicology in the Pharmaceutical Industry --  |t Strategy and Phasing for Nonclinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals --  |t The Application of In Vitro Techniques in Drug Safety Assessment --  |t Evaluation of Human Tolerance and Safety in Clinical Trials : Phase I and Beyond --  |t Postmarketing Safety Evaluation : Monitoring, Assessing, and Reporting of Adverse Drug Responses (Adrs) --  |t Statistics in Pharmaceutical Safety Assessment --  |t Combination Products : Drugs and Devices --  |t Qualification of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals --  |t Tissue, Cell, and Gene Therapy --  |t Adverse Outcome Pathways in Drug Safety Assessment --  |g Appendix A.  |t Selected Regulatory and Toxicological Acronyms --  |g Appendix B.  |t Definition of Terms and Lexicon of "Clinical" Observations in Nonclinical (Animal) Studies --  |g Appendix C.  |t Notable Regulatory Internet Addresses --  |g Appendix D.  |t Glossary of Terms Used in the Clinical Evaluation of Therapeutic Agents --  |g Appendix E.  |t Common Vehicles for the Nonclinical Evaluation of Therapeutic Agents --  |g Appendix F.  |t Global Directory of Contract Toxicology Labs. 
504 |a Includes bibliographical references and index. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
520 |a "This new edition of Drug Safety Evaluation presents an all-inclusive practical guide for those who are responsible for developing new drugs and ensuring the safety of an ever-expanding spectrum of therapeutics. This book helps readers understand how the safety of these products are evaluated for use. Extensively revised to reflect up-to-date information, this edition includes changes to the scope of products (vaccines, small synthetic, large protein moieties, cells and tissues), harmonized global and national regulatory requirements, the therapeutic development process, and available technologies to identify and evaluate the relevance of potential patient risks. The revised chapter, and inclusion of brand-new chapters, address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (including carcinogenicity, developmental toxicity, immunogenicity and immunotoxicity) to provide both understanding and guidance for approaching new problems"--  |c Provided by publisher. 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Drugs  |x Toxicology. 
650 0 |a Drugs  |x Testing. 
650 0 |a Pharmacovigilance. 
650 0 |a Drugs  |x Side effects  |x Reporting. 
650 0 |a Drug monitoring. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
700 1 |a Sullivan, Dexter W.,  |c Jr.,  |e author. 
776 0 8 |i Print version:  |a Gad, Shayne C., 1948-  |t Drug safety evaluation  |b 4th edition.  |d Hoboken, NJ : Wiley, 2023  |z 9781119755852  |w (DLC) 2022042520 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpDSE00031/drug-safety-evaluation?kpromoter=marc  |y Full text 

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