Strengthen Your Regulatory Submissions Through Strategic Storyboarding
By Young-Sil (Anna) Yim, Senior Director, Regulatory Affairs at Allucent Introduction A successful marketing authorization application is expected to convey the complete story of the drug in a clear, harmonized, and strategic manner. The process is rarely easy, as the authoring process requires distilling the full product development journey, starting from early activities including CMC […]
Clinical Pharmacology Studies to Support Filing Packages and Labeling
Explore with Neha Bhise, Ph.D. the clinical pharmacology studies that are critical to inform labeling and filing packages, their significance on drug development, as well as other various aspects, such as: First-in human, food effect studies, bioavailability studies, and more. https://youtu.be/ZsoWHmcF9A4 Learn more about Allucent’s clinical pharmacolgy expertise here. Click here
Mastering Clinical Trial Design: Will FDA’s Latest Guidance on Master Protocols Encourage Increased Adoption?
By Sugato De (VP, Regulatory Strategy, Head of Medtech) and Michelle Hoffner O’Connor (Clinical Strategy Scientist II) On December 21, 2023, the Food and Drug Administration (FDA) issued a draft guidance entitled “Master Protocols for Drug and Biological Product Development.” Master protocols originated as an efficient mechanism to determine which therapies may drive the most […]
Efficient Clinical Programs and Decision Making Through Model-Informed Drug Development (MIDD)
Efficient Clinical Programs and Decision Making Through Model-Informed Drug Development (MIDD) Join Alex MacDonald, VP Model-Informed Drug Development, on how MIDD can help your clinical trials.
Anti-Depression Medication: Current Landscape and Product Development Trends
Alison Wakeford, PhD, Scientist, Allucent Marcus S. Delatte, PhD, VP Regulatory Strategy, Allucent Background According to the World Health Organization, depression is a common mood disorder, affecting approximately 280 million people globally.1 Depression is characterized by persistent feelings of sadness and loss of interest, occurs across almost all age groups, and manifests in various forms […]