- Created: August 30, 2009
- Type: Professional Group
- Members: 183
- Owner: Lynda C.
The discussions are about the challenges of Phase I and BA/BE clinical studies: Pharmacokinetics/Pharmacodynamics, Pharmacology, Biostatistics and Assessment. Study design, protocol writing, execution and how it's react in the real-life, CRF design and completion, ICF, Ethics, Regulatory, clinical operations based on SOPs, GCP, ICH.
Beyond the bioequivalence: the interchangeability (change patient from innovator to generic drug, and from generic to generic).
The group is for active members only, at least one contribution each 3 months is required.
For a pre-approved invitation please include your e-address when you apply.
