Free download Drug Safety Evaluation (4th edition) by Shayne Cox Gad & Dexter W. Sullivan Jr. in pdf.
This fourth edition of Drug Safety Evaluation is a revision of the third edition that 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 and shepherding valuable candidates to market, 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.
The 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.
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Individual chapters also 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 and development toxicity) 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.
Drug Safety Evaluation specifically aims at the pharmaceutical and biotechnology industries. It addresses not only the general cases for safety evaluation of small and large molecules but also all of the significant major subcases: imaging agents, dermal and inhalation route drugs, vaccines, and gene therapy products.
It is hoped that the approaches and methodologies presented here will 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.
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
- Repeat-Dose 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
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