£220.00
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
Specification of Drug Substances and Products
Pharmaceutical Product Licensing
Generic Drug Product Development
International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products
Understanding Pharmaceutical Standards and Regulations
Specification of Drug Substances and Products
FDA Regulatory Affairs