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 that can fast-track the CTA process and get the approval for...
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 a long and arduous one. Even after years of research, extensive clinical trials, and...
Drug interaction management is a significant concern in designing clinical trials, especially those focusing on pharmacokinetic (PK) endpoints. Such interactions, both expected or unexpected drug-drug interactions, may arise from the prescribed treatment regimen,...
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 medications to reach patients in need. But how do drugs reach this...
No stranger to adversity, Olayiwola (Ola) Kassim was born and raised in Lagos, Nigeria. From an early age he saw doctors as heroes, as personified by his uncle who studied nursing abroad in the UK and his sister who later did the same. He lost his mother at only 3...
Clinical study protocols are conducted according to the International Council for Harmonization guidance on Good Clinical Practice (GCP) which outlines safeguards for the rights, safety and well-being of participants. Protocols “should [also] be designed, conducted...
