The life cycle of a drug is a complex process that involves many stages, from the initial concept and discovery of the drug to its final approval and post-marketing surveillance.
Each stage involves different topics and disciplines, including biology, chemistry, pharmacology, statistics, ethics, law, and more.
Below is an exhaustive list of topics that are involved in the life cycle of a drug:
1. Drug Discovery:
- Identification of Diseases and Target Selection
- Lead Discovery and Optimization
- High Throughput Screening
- Drug Design
- Preclinical In-vitro Studies
- Drug Formulation Studies
2. Preclinical Research:
- Preclinical Pharmacology and Toxicology Studies
- Animal Models for Drug Testing
- Safety Pharmacology
- ADME Studies (Absorption, Distribution, Metabolism, and Excretion)
- Pharmacokinetics and Pharmacodynamics
3. Investigational New Drug (IND) Application:
- Preparing IND Application
- Regulatory Requirements for IND
- Ethical and Legal Considerations
4. Clinical Trials:
- Clinical Trial Design
- Phases of Clinical Trials (Phase I, Phase II, Phase III)
- Biostatistics
- Data Collection and Management
- Clinical Trial Regulations and Ethics
- Patient Recruitment and Retention
- Adverse Event Reporting
- Pharmacovigilance
5. New Drug Application (NDA) / Marketing Authorization Application (MAA):
- Preparing NDA/MAA
- Regulatory Requirements for NDA/MAA
- Risk-Benefit Analysis
6. Regulatory Review and Drug Approval:
- Regulatory Guidelines (FDA, EMA, etc.)
- Post-marketing Requirements
- Good Manufacturing Practices (GMP)
7. Pharmaceutical Manufacturing:
- Scale-up Processes
- Quality Assurance and Quality Control
- Validation Procedures
8. Post-marketing Surveillance:
- Pharmacovigilance
- Post-marketing Clinical Trials (Phase IV)
- Post-marketing Risk Assessment
- Adverse Drug Reaction (ADR) Reporting
9. Patenting and Intellectual Property:
- Patent Application
- Patent Laws and Regulations
- Patent Expiry and Generic Drugs
10. Drug Pricing and Reimbursement:
- Pricing Strategies
- Health Technology Assessment (HTA)
- Pharmacoeconomics
11. Drug Withdrawal:
- Reasons for Drug Withdrawal
- Process and Implications of Drug Withdrawal