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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.
This cutting-edge resou
ICH Quality Guidelines
International Stability Testing
International Regulatory Harmonization Amid Globalization of Drug Development
Specification of Drug Substances and Products
Nonclinical Safety Assessment
Pharmaceutical Product Licensing
Specification of Drug Substances and Products
International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products
Generic Drug Product Development
Global Regulations of Medicinal, Pharmaceutical, and Food Products
Interplay of Global Standards and EU Pharmaceutical Regulation
Specification of Drug Substances and Products
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