In May 2024, the International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a final draft of the newly developed scientific guidance on drug-drug interaction (DDI) studies, ICH M12, that will be adopted by ICH-abiding regulatory...
Expertise: Consulting 228 results
A Target Product Profile (TPP) serves as the primary strategic framework that aligns commercial and clinical workstreams. When properly defined, the TPP enables drug developers to manage the development equation of risk x cost x time = success, and it...
Consulting
Andrew Emanuel, MSc, BSc
Consulting
Scott Boreham
Consulting
Rashawn Turner
Consulting
Tony Phillips
Consulting
Siegrid Delgadillo, MPH
Consulting
Tiffany Dorotheo
Consulting
Isaac Asante, Ph.D.
Consulting