ABSTRACT
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
TABLE OF CONTENTS
part I|74 pages
Administrative Guidelines for New Product Development
part II|226 pages
Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval
part III|138 pages
Developing Clinical Research Trials
part V|69 pages
Specific Areas of New Product Submissions