UNIT 2: Drug Discovery and Development Lifecycle
This unit explains the complete pharmaceutical product lifecycle from drug discovery to post-marketing surveillance through a regulatory lens. It connects scientific development activities with regulatory decision-making, approvals, and compliance expectations across FDA, EMA, and CDSCO.
Definition
Drug discovery is the process of identifying new chemical or biological substances that can be developed into medicines to affect specific targets in the body. It involves understanding a disease, finding a molecule that can influence the biological pathway causing it, and optimizing that molecule to ensure it is safe and effective.
Drug discovery is needed not only to cure diseases but also to prevent them (like vaccines), to manage or mitigate symptoms (such as pain relievers or anti‑inflammatory drugs), and to control chronic or life‑threatening conditions where a complete cure may not be possible (e.g., hypertension or diabetes medications). Overall, it ensures continuous development of therapies that improve quality of life, reduce suffering, and protect populations from emerging health threats.
Key Points
Identifying & Validating Targets – Drug discovery begins with finding a biological target and confirming it plays a key role in the disease.
Designing Safe & Effective Molecules – Researchers screen and optimize compounds to ensure they work on the target while being safe and effective
Preventing, Treating & Managing Diseases – New drugs are developed not only to cure diseases but also to prevent them (like vaccines) or mitigate symptoms in chronic conditions.
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