The entire process of taking a newly discovered compound or drug through regulatory approval to the point of marketing. During the development, the new drug or the compound should adhere to high standards in the conduct, analysis and interpretation of preclinical and clinical studies for its smooth passage through the regulatory approval phase and eventually to marketing. The drug discovery and drug development process is designed to ensure that only those pharmaceutical products that are both safe and effective are brought to market.

This topic covers: Drug development phases, Approaches of Drug Discovery: Pharmacological Approach, Toxicological Approach, Drug characterization: Biological Characterization, Physiochemical Characterization, Biochemical Assay, Cellular Assay, System/Whole animal Assay, Physiochemical Characterization, Dosage form, Investigational New Drug Development (IND), Investigator IND, Emergency Use IND and Treatment IND.

Drug development process

Also checkout: Full Clinical Research Notes Pharm.D Notes for Other Subjects