Main description:

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 harmonization
a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
the latest regulatory requirements for expediting new drug approvals
strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

Contents:

Administrative Guidelines for New Product Development. Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval. Developing Clinical Research Trials. Global Regulations for Good Clinical Practices (GCP). Specific Areas of New Product Submissions.