Tools

LEADER 06535cam 2200673 i 4500

001 on1350644621;

003 OCoLC;

005 20230502113721.0;

006 m o d ;

007 cr cnu---unuuu;

008 220906t20232023njua ob 001 0 eng ;

010 a| 2022042521;

020 a| 9781119755883q| (electronic bk. : oBook);

020 a| 9781119755876q| electronic book;

020 a| 1119755875q| electronic book;

020 a| 9781119755869q| electronic book;

020 a| 1119755867q| electronic book;

020 a| 1119755883q| electronic book;

020 z| 9781119755852q| hardcover;

024 7 a| 10.1002/97811197558832| doi;

035 a| (Sirsi) o1350644621;

035 a| (OCoLC)1350644621;

042 a| pcc;

049 a| NEHH;

050 04 a| RA1238b| .G33 2023;

060 10 a| QV 771;

082 00 a| 615/.192| 23/eng/20221110;

100 1 a| Gad, Shayne C.,d| 1948-e| author.=| ^A296788;

245 10 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.;

300 a| 1 online resource (xxxi, 960 pages) :b| illustrations;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

505 00 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| RepeatUDose 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.;

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.;

588 a| Description based on online resource; title from digital title page (viewed on January 05, 2023).;

650 0 a| Drugsx| Toxicology.=| ^A2811;

650 0 a| Drugsx| Testing.=| ^A4660;

650 0 a| Pharmacovigilance.=| ^A1361985;

650 0 a| Drugsx| Side effectsx| Reporting.=| ^A888184;

650 0 a| Drug monitoring.=| ^A404118;

650 12 a| Drug Evaluation, Preclinical.=| ^A938316;

650 22 a| Drug Evaluation.=| ^A917639;

650 22 a| Product Surveillance, Postmarketing.=| ^A928242;

700 1 a| Sullivan, Dexter W.,c| Jr.,e| author.=| ^A1457019;

856 40 z| Direct link to eBooku| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=7164149;

949 a| CLICK ON WEB ADDRESSw| ASISh| HSL102p| $338.100| HSLo| HMT;

949 a| CLICK ON WEB ADDRESSw| ASISh| JOYNER96o| HMT;

994 a| C0b| NEH;

596 a| 1 4;

998 a| 6093905;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6093905-1001l| HSLELECm| HSLp| $338.10r| Ys| Yt| HGENEBKu| 5/2/2023x| EBOOKz| HERESOURCE0| HSLo| .STAFF. HMT;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6093905-2001l| JNETm| JOYNERr| Ys| Yt| JNE3BKu| 5/2/2023x| EBOOKz| JERESOURCEo| .STAFF. HMT;

Drug safety evaluation / Shayne Cox Gad, Dexter W. Sullivan, Jr.

Author/creator	Gad, Shayne C., 1948- author.
Other author	Sullivan, Dexter W., Jr., author.
Format	Electronic
Edition	Fourth edition.
Publication	Hoboken, NJ : John Wiley & Sons, Inc., 2023.
Copyright Date	©2023
Description	1 online resource (xxxi, 960 pages) : illustrations
Supplemental Content	Direct link to eBook
Subjects	Drugs--Toxicology. Drugs--Testing. Pharmacovigilance. Drugs--Side effects. --Reporting. Drug monitoring. Drug Evaluation, Preclinical. Drug Evaluation. Product Surveillance, Postmarketing.

Contents	The Drug Development Process and the Global Pharmaceutical Marketplace -- Regulation of Human Pharmaceutical Safety : Routes to Human Use and Market -- Data Mining : Sources of Information for Consideration in Study and Program Design and in Safety Evaluation -- Electronic Records, Reporting, and Submission : eCTD and Send -- Screens in Safety and Hazard Assessment -- Formulations, Routes, and Dosage Regimens -- Mechanisms and End Points of Drug Toxicity -- Pilot Toxicity Testing in Drug Safety Evaluation : MTD and DRF -- RepeatUDose Toxicity Studies -- Genotoxicity -- QSAR Tools for Drug Safety -- Toxicogenomics -- Immunotoxicology in Drug Development -- Nonrodent Animal Studies -- Developmental and Reproductive Toxicity Testing -- Carcinogenicity Studies -- Histopathology and Clinical Pathology 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 : Imaging Agents -- Special Case Products : Drugs for Treatment of Cancer -- Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile and Pediatric 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 : Phase I and Beyond -- Postmarketing Safety Evaluation : Monitoring, Assessing, and Reporting of Adverse Drug Responses (Adrs) -- Statistics in Pharmaceutical Safety Assessment -- Combination Products : Drugs and Devices -- Qualification of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals -- Tissue, Cell, and Gene Therapy -- Adverse Outcome Pathways in Drug Safety Assessment -- 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 Toxicology Labs.
Abstract	"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"-- Provided by publisher.
Bibliography note	Includes bibliographical references and index.
Source of description	Description based on online resource; title from digital title page (viewed on January 05, 2023).
Issued in other form	Print version: Gad, Shayne C., 1948- Drug safety evaluation 4th edition. Hoboken, NJ : Wiley, 2023 9781119755852
LCCN	2022042521
ISBN	9781119755883 (electronic bk. : oBook)
ISBN	9781119755876 electronic book
ISBN	1119755875 electronic book
ISBN	9781119755869 electronic book
ISBN	1119755867 electronic book
ISBN	1119755883 electronic book
ISBN	hardcover
Standard identifier#	10.1002/9781119755883

Availability

Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Access Content Online	✔ Available

Drug safety evaluation / Shayne Cox Gad, Dexter W. Sullivan, Jr.

Click here for more information about this title

Availability