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...
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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 unexpected drug-drug interactions, may arise from the prescribed treatment regimen,...
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 medications to reach patients in need. But how do drugs reach this...
It Takes a Village: An Interview with Dr. Ola Kassim
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...
Exploring Clinical Trial Protocol Deviation: A Comprehensive Guide
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...
Crafting Workplace Symphony at a CRO
Unveiling the Canvas: A Maestro's Tale In the heart of BioPharma Services' flourishing ecosystem stands the People and Culture Champion. Functioning as the architect of engagement, a mediator in reducing turnover, and a meticulous curator of our organizational...