The Pharma Data
JANUARY 27, 2021
These include in-vitro assays, cell-based phenotypic assays, safety pharmacology and efficacy, ADME toxicology, medicinal chemistry design, synthetic chemistry, and custom proteins and assay development capabilities.
FDA Law Blog: Drug Discovery
JANUARY 4, 2023
The Agency recommended that product developers begin designing potency assay(s) early, and developing and evaluating multiple potency assays since not all potency assays can be validated and some potency assays may not fully reflect the biological activity.
Drug Target Review
OCTOBER 10, 2024
To accelerate the development of cell and gene therapies using diseased donor material, regulatory reforms should prioritise adaptive licensing pathways, flexible trial designs, and the use of predictive biomarkers. Healthy cells may also serve as a valuable control in experiments.
Expert insights. Personalized for you.
52 
Let's personalize your content