The process of drug discovery and development begins with basic scientific research. Studies in three categories are usually carried out during this stage: 1) Biological Screening and Pharmacological Testing: these are studies to explore the pharmacological activity and therapeutic potential of compounds; 2) Pharmaceutical Dosage Formulation and Stability Testing: The process of turning an active compound into a form and strength suitable for human use; 3) Toxicology and Safety Testing: Tests to determine the potential risk a compound poses to animals, tissue cultures, and other test systems prior to their human introduction.
Drug screening process consists of testing many compounds in assays relevant to the disease of interest. If a compound or its structural derivatives continue to show promise after further biological and chemical characters, they are potential leads to enter the formal drug development process.
The research process is complicated, time-consuming, costly and the end result is never guaranteed. Followings are some useful regulations and guidance that the US FDA published for the basic research of drug development on:
- Lead Identification
- Synthesis Scale-up
- In-Vitro Pharmacology
- U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook
- Guidance on ICH Q6A: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Chemistry, Manufacturing, and Controls (CMC)
- Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals
- Guidance for Industry S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals