{"product_id":"drug-safety-evaluation-isbn-9781119755852","title":"Drug Safety Evaluation","description":"\u003cp\u003e\u003cb\u003eDrug Safety Evluation\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eComprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThis fourth edition of \u003ci\u003eDrug Safety Evaluation\u003c\/i\u003e maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market.\u003c\/p\u003e \u003cp\u003eIndividual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought.\u003c\/p\u003e \u003cp\u003eThe many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters.\u003c\/p\u003e \u003cp\u003eSpecific sample topics covered in \u003ci\u003eDrug Safety Evaluation\u003c\/i\u003e include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eThe drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety\u003c\/li\u003e \u003cli\u003eSources of information for consideration in study and program design and in safety evaluation\u003c\/li\u003e \u003cli\u003eElectronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens\u003c\/li\u003e \u003cli\u003eMechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity\u003c\/li\u003e \u003cli\u003eGenotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing\u003c\/li\u003e \u003cli\u003eAn appendix which provides an up to date guide to CROs for conducting studies\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eDrug Safety Evaluation\u003c\/i\u003e was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.\u003c\/p\u003e \u003cp\u003ePREFACE xxix\u003c\/p\u003e \u003cp\u003eABOUT THE AUTHORS xxxi\u003c\/p\u003e \u003cp\u003e1 The Drug Development Process and The Global Pharmaceutical Marketplace 1\u003c\/p\u003e \u003cp\u003e2 Regulation of Human Pharmaceutical Safety: Routes To Human Use and Market 19\u003c\/p\u003e \u003cp\u003e3 Data Mining: Sources of Information For Consideration In Study And Program Design and In Safety Evaluation 67\u003c\/p\u003e \u003cp\u003e4 Electronic Records, Reporting, and Submission: eCTD and Send 75\u003c\/p\u003e \u003cp\u003e5 Screens in Safety and Hazard Assessment 83\u003c\/p\u003e \u003cp\u003e6 Formulations, Routes, and Dosage Regimens 95\u003c\/p\u003e \u003cp\u003e7 Mechanisms And End Points Of Drug Toxicity 131\u003c\/p\u003e \u003cp\u003e8 Pilot Toxicity Testing In Drug Safety Evaluation: MTD and DRF 143\u003c\/p\u003e \u003cp\u003e9 Repeat-Dose Toxicity Studies 173\u003c\/p\u003e \u003cp\u003e10 Genotoxicity 183\u003c\/p\u003e \u003cp\u003e11 QSAR Tools For Drug Safety 223\u003c\/p\u003e \u003cp\u003e12 Toxicogenomics 241\u003c\/p\u003e \u003cp\u003e13 Immunotoxicology In Drug Development 247\u003c\/p\u003e \u003cp\u003e14 Nonrodent Animal Studies 293\u003c\/p\u003e \u003cp\u003e15 Developmental And Reproductive Toxicity Testing 331\u003c\/p\u003e \u003cp\u003e16 Carcinogenicity Studies 363\u003c\/p\u003e \u003cp\u003e17 Histopathology and Clinical Pathology In Nonclinical Pharmaceutical Safety Assessment 395\u003c\/p\u003e \u003cp\u003e18 Irritation And Local Tissue Tolerance In Pharmaceutical Safety Assessment 403\u003c\/p\u003e \u003cp\u003e19 Pharmacokinetics And Toxicokinetics In Drug Safety Evaluation 425\u003c\/p\u003e \u003cp\u003e20 Safety Pharmacology 457\u003c\/p\u003e \u003cp\u003e21 Special Concerns For The Preclinical Evaluation Of Biotechnology Products 477\u003c\/p\u003e \u003cp\u003e22 Safety Assessment of Inhalant Drugs And Dermal Route Drugs 507\u003c\/p\u003e \u003cp\u003e23 Special Case Products: Imaging Agents 529\u003c\/p\u003e \u003cp\u003e24 Special Case Products: Drugs For Treatment Of Cancer 535\u003c\/p\u003e \u003cp\u003e25 Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile And Pediatric Toxicology) 543\u003c\/p\u003e \u003cp\u003e26 Use Of Imaging, Imaging Agents, And Radiopharmaceuticals In Nonclinical Toxicology 551\u003c\/p\u003e \u003cp\u003e27 Occupational Toxicology In The Pharmaceutical Industry 571\u003c\/p\u003e \u003cp\u003e28 Strategy and Phasing For Nonclinical Drug Safety EvaluationIn The Discovery and Development of Pharmaceuticals 585\u003c\/p\u003e \u003cp\u003e29 The Application of In Vitro Techniques In Drug Safety Assessment 603\u003c\/p\u003e \u003cp\u003e30 Evaluation Of Human Tolerance And Safety In Clinical Trials: Phase I And Beyond 635\u003c\/p\u003e \u003cp\u003e31 Postmarketing Safety Evaluation: Monitoring, Assessing, And Reporting of Adverse Drug Responses (ADRs) 683\u003c\/p\u003e \u003cp\u003e32 Statistics In Pharmaceutical Safety Assessment 707\u003c\/p\u003e \u003cp\u003e33 Combination Products: Drugs and Devices 767\u003c\/p\u003e \u003cp\u003e34 Qualification Of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals 777\u003c\/p\u003e \u003cp\u003e35 Tissue, Cell, and Gene Therapy 789\u003c\/p\u003e \u003cp\u003e36 Adverse Outcome Pathways in Drug Safety Assessment 801\u003c\/p\u003e \u003cp\u003eAppendix A: Selected Regulatory and Toxicological Acronyms 805\u003c\/p\u003e \u003cp\u003eAppendix B: Definition Of Terms And Lexicon of \"Clinical\" Observations in Nonclinical (Animal) Studies 807\u003c\/p\u003e \u003cp\u003eAppendix C: Notable Regulatory Internet Addresses 811\u003c\/p\u003e \u003cp\u003eAppendix D: Glossary Of Terms Used in The Clinical Evaluation of Therapeutic Agents 817\u003c\/p\u003e \u003cp\u003eAppendix E: Common Vehicles For The Nonclinical Evaluation of Therapeutic Agents 821\u003c\/p\u003e \u003cp\u003eAppendix F: Global Directory of Contract Toxicology Labs 919\u003c\/p\u003e \u003cp\u003eINDEX 945\u003c\/p\u003e   \u003cp\u003e\u003cb\u003eShayne Cox Gad, PhD, DABT \u003c\/b\u003eis the Principal of Gad Consulting Services. He has more than 47 years of experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He has successfully file 138 INDs and authored and edited 52 books, as well as numerous papers, presentations, and other publications.  \u003c\/p\u003e\u003cp\u003e\u003cb\u003eDexter W. Sullivan, Jr., MS, DABT \u003c\/b\u003eis Senior Toxicologist at Gad Consulting Services.    \u003c\/p\u003e\u003cp\u003e\u003cb\u003eComprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003e This fourth edition of \u003ci\u003eDrug Safety Evaluation \u003c\/i\u003emaintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. \u003c\/p\u003e\u003cp\u003eIndividual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. \u003c\/p\u003e\u003cp\u003eThe many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. \u003c\/p\u003e\u003cp\u003eSpecific sample topics covered in \u003ci\u003eDrug Safety Evaluation \u003c\/i\u003einclude: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eThe drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety\u003c\/li\u003e \u003cli\u003eSources of information for consideration in study and program design and in safety evaluation\u003c\/li\u003e \u003cli\u003eElectronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens\u003c\/li\u003e \u003cli\u003eMechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity\u003c\/li\u003e \u003cli\u003eGenotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing\u003c\/li\u003e \u003cli\u003eAn appendix which provides an up to date guide to CROs for conducting studies\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e\u003ci\u003eDrug Safety Evaluation \u003c\/i\u003ewas written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989088616677,"sku":"NP9781119755852","price":345.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119755852.jpg?v=1761782747","url":"https:\/\/k12savings.com\/products\/drug-safety-evaluation-isbn-9781119755852","provider":"K12savings","version":"1.0","type":"link"}