Leveraging the 505(b)(2) Program to Prolong the Life of a New Chemical Entity (NCE)
Leveraging the 505(b)(2) Program to Prolong the Life of a New Chemical Entity (NCE) This is an continuation of When is 505b2 a good choice for your new drug application? In the world of pharmaceuticals and drug development, the journey from discovery to market can be...
Importance of Study Restriction: The Avoidance of Drug-Drug Interactions Part 1
Importance of Study Restriction: The Avoidance of Drug-Drug Interactions Part 1 Drug interaction management is a significant concern in designing clinical trials, especially those focusing on pharmacokinetic (PK) endpoints. Such interactions, both expected or...
ANDA or 505(b)(2): Choosing the Right Approval Pathway for Your Drug
ANDA or 505(b)(2): Choosing the Right Approval Pathway for Your Drug 505(b)(2) pathway approvals have experienced double-digit growth recently. Many drug companies are electing to pursue 505(b)(2) applications to obtain a new drug approval (NDA). For developers...
The Role of AI in Clinical Trials
The Role of AI in Clinical Trials Artificial intelligence (AI) – based technologies are increasingly finding applications in multiple industries, including the pharmaceutical field. AI integration into drug development contributes to the enhancement of testing...
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