Second Edition
edited by Anthony Cartwright
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.
The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.
International Pharmaceutical Product Registration includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission.
International Pharmaceutical Product Registration is organized into six practical segments:
- CTD, eCTD, Module 1, and Environmental Risk Assessment
- CTD Summaries
- Quality Topics
- Nonclinical Topics
- Clinical Topics
- Other Topics, such as drug-device combination products
The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also discussed.
Contents
Introduction and Specific Requirements
- The Common Technical Document—A Global Format for Registration Files
- The Electronic Common Technical Document
- CTD Module 1—Administrative Information
- Environmental Risk Assessment
Common Technical Document Summaries
- Quality Overall Summary
- The Nonclinical Overview and Summary
- The Clinical Overview and Summary
Quality—Drug Substance and Drug Product
- Drug Substance—General Information
- Drug Substance—Manufacture
- Drug Substance—Characterization
- Control of Drug Substance
- Drug Substance and Drug Product—Container/Closure
- Drug Product—Description and Composition
- Drug Product—Pharmaceutical Development
- Drug Product—Manufacture and Process Validation
- Drug Product—Excipients
- Control Tests on the Finished Product
- Reference Standards or Materials
- Drug Substance and Drug Product Stability
- Transmissible Spongiform Encephalopathy Agent and Adventitious Agent
Requirements for Non-Biological Pharmaceutical Products
Nonclinical Studies
- Nonclinical Testing Strategy
- Pharmacology
- Nonclinical Pharmacokinetics and Toxicokinetics
- Single and Repeat Dose Toxicity
- Genotoxicity
- Carcinogenicity
- Reproductive and Developmental Toxicity
- Safety Pharmacology Testing: Past, Present, and Future
- Immunotoxicology
- Local Tolerance and Other Toxicity Studies
Clinical Studies
- Bioavailability and Bioequivalence Studies
- Pharmacokinetics in Man
- Pharmacodynamics
- Statistical Concepts in the Design and Analysis of Clinical Trials
- Efficacy and Safety Clinical Studies
- Postmarketing Evaluation
- Guenter Hennings
- Pharmacovigilance and Risk Management
- Pregnancy and Children
- Ageing Populations and Development of Medicinal Products
- Good Clinical Practice
- Prevention and Detection of Fraud in Clinical Trials
Special Products and Modeling
- Aspects of Biological and Biotechnological Medicinal Products
- Device-Drug Combination Products
- Recommendations for Toxicological Evaluation of Nanoparticle Medicinal Products
- Modeling and Medical Product R&D
Index
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