Stages of Drug Development
1. Discovery and Compound Selection
Identification of therapeutic targets
Search and design of candidate molecules (chemical or biological)
In silico studies and compound library screening
2. Preclinical Studies
Objective: To evaluate toxicity, pharmacokinetics, and pharmacodynamics in animal models
In vitro and in vivo studies
Assessment of a safe starting dose for human trials
Preparation of the preclinical research report
3. Pharmaceutical Development
Design of the dosage form (tablet, capsule, injectable, etc.)
Stability studies, pilot-scale manufacturing, and process validation
Compliance with Good Manufacturing Practices (GMP)
4. Clinical Research (Phases I to IV)
Phase I: Safety, tolerability, and pharmacokinetics in healthy volunteers
Phase II: Preliminary efficacy and side effect profile in patients
Phase III: Large-scale confirmation of efficacy and comparison with existing treatments
Phase IV: Post-marketing studies, long-term safety, and real-world evidence
5. Regulatory Submission and Marketing Authorization
Preparation of the regulatory dossier (CTD: Common Technical Document)
Submission to regulatory agencies (EMA, FDA, AEMPS, etc.)
Scientific evaluation and official approval
6. Commercial Production
Industrial scale-up and process validation
Quality assurance and quality control (QA/QC)
Traceability, labeling, and distribution
7. Pharmacovigilance and Post-Market Surveillance
Active system for reporting adverse drug reactions
Periodic Safety Update Reports (PSURs)
Potential label updates, usage restrictions, or market withdrawal
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