Eight Reasons to Choose Canada for Your Phase 1 Clinical Trial
Eight Reasons to Choose Canada for Your Phase 1 Clinical Trial For many study sponsors, the end goal of their clinical drug development program is to enter the United States drug market. However, conducting your Phase 1 clinical trial in Canada is an alternative route...
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...
NDA Enabled Phase 1 Clinical Trials: Unveiling the First Step
NDA Enabled Phase 1 Clinical Trials: Unveiling the First Step The journey of a new drug from concept to market is a complex and highly regulated process. At its core lies the New Drug Application (NDA) submission – a critical milestone that paves the way for new...
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