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.
Pay easily by card, Klarna, Apple Pay or Google Pay. Not happy? You always have a 14-day money-back guarantee. Read more in our terms. If you have any questions, email us at hello@memmo.org.
Memmo makes studying easier – wherever you are in the world. We bring your course books and smart study tools together in one place: summaries, quizzes, podcasts and flashcards. Plus Ted, your study buddy who answers anything you wonder. Over 75,000 students already study here – built to help you learn faster and stress less.