Pharmaceutical Issues. Shanker Gupta, Ph.D. Pharmaceutical Resources Branch (PRB). Requirements. Chemical Substance to Human Drug Standardize Processes to Establish Identity Quality Purity Strength. Operational Areas. Bulk Drug Synthesis Analytical Development & Validation
Shanker Gupta, Ph.D.
Pharmaceutical Resources Branch (PRB)
Chemical Substance to Human Drug
Provide Solution of Active Drug for IV Use.
Solution components should be:
Dr. Joseph Covey
Toxicology & Pharmacology Branch
Developmental Therapeutics Program