A scientific basis on which generic and brand name drugs are compared with one another. Drugs are bioequivalent if they enter circulation at the same rate when given in similar doses under similar conditions. Proof of bioequivalence is crucial for generic drugs, and must be demonstrated in ANDAs.
Glossary
Bioequivalence
02.27.12
-
Bachem Capabilities to Address the New FDA Guideline for Synthetic Peptides
Scientific and regulatory challenges remain a big hurdle on the way to successful approval of generic drugs falling under this guideline.Released by: Bachem
-
Breaking News | Facilities | Industry News | Injectables | Parenterals
Civica to Build an Essential Medicines Manufacturing Facility in Virginia
Will produce sterile injectable meds used in hospitals for COVID-19 patient care.Tim Wright, Editor, Contract Pharma
-
Clinical Development
Syngene supports early-phase to late-phase clinical trials required for drug development programs across a wide range of therapeutic areas.Released by: Syngene International Ltd.
-
Promotions & Moves
Akebia Therapeutics Names CMO
Jain to lead clinical development of the company’s HIF pipeline
-
Biologics, Proteins, Vaccines | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer
Merck, Stelis Open First Joint Process Scale-Up Lab in Bengaluru
Combines Stelis' bioprocess development capabilities with Merck's bioprocessing equipment
