1. Perform any necessary preformulation studies to determine physical/chemical properties of drug substances targeted for formulation development. These determinations may include identification of pKa's, partition coefficients, solubility in various solvents, pH-solubility profiles, pH-rate profiles, identification of drug-excipient interactions and estimates of short term stability.2. Characterize the chemical nature of bulk drug substances (including identity and purity), quantitate and assess the stability of drug substances and conduct short term stability studies (30-90 day) of drug products in compliance with GMPs if necessary, and investigate drug release properties in vitro.3. DEVELOP NEW DOSAGE FORMS4. CONDUCT PILOT-SCALE MANUFACTURING5. CONDUCT GMP-COMPLIANT MANUFACTURING OF CLINICAL SUPPLIES6. PERFORM QUALITY CONTROL TESTING7. CONDUCT SHELF LIFE STABILITY STUDIES8. DOCUMENT THE CHARACTERISTICS OF DRUG SUBSTANCES AND DRUG PRODUCTS9. SHIP CLINICAL BATCHES10. ANALYTICAL ASSAYS
