The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step

part II|226 pages

Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval

chapter 15|14 pages

Orphan Drugs

part III|138 pages

Developing Clinical Research Trials

chapter 16|24 pages

Clinical Research Protocols

part V|69 pages

Specific Areas of New Product Submissions