Found 31 presentations matching your search
ANDA REGULATORY APPROVAL PROCESS & IN-VITRO STUDIES BY MS PYNSKHEMLIN SYIEMLIEH 1ST SEM M...
documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distr...
Master formula record, DMF (Drug Master File), Distribution records. Generic drugs product developme...
Process involved in Generic product development
general ANDA review
This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. A...
Basic information for beginners...
It is applicable for the Generic drugs
Regulatory requirements of BIOAVAILABLITY & BIOEQUIVALENCE STUDIES
NEW DRUG APPLICATION INVESTIGATIONAL NEW DRUG ABBREVIATED NEW DRUG APPLICATION
Bioavailability and bioequivalence
Biosimilars
Non Clinical Drug Development: Global submission of IND, NDA, ANDA.
SUPAC respresents the changes recommended by US FDA at the time of scale up or approval of NDA / AND...
Nill
B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory). Unit-I Chapter...
Documentation in Pharmaceutical Industry - master formula record , DMF ( DRUG MASTER FILE )
Technology Transfer Pilot Plant scale up supac guidelines
Pharmaceutical Manufacturing Technology
B. Pharm. Final Year, Sem:- VII, INDUSTRIAL PHARMACY-II, Pilot plant scale up techniques, As per PC...
pharmaceutics
New Drug Application (NDA) Filing
bioavailability(BA) studies
Biopharmaceutical Classification System
