Drug safety assessment is a critical process in the development and approval of pharmaceuticals, ensuring that the benefits of a drug outweigh its risks before it reaches the market. It involves a combination of preclinical studies, clinical trials, and post-marketing surveillance to monitor adverse effects and ensure ongoing patient safety.

Drug Safety Assessment

Development and approval of pharmaceuticals

Benefits of a drug

Risks of a drug

Preclinical studies are a crucial phase in the drug development process where potential therapeutic compounds are tested in vitro and in vivo to evaluate their safety, efficacy, and pharmacokinetics before progressing to human trials. These studies provide foundational data that help determine whether a drug candidate is viable for clinical trials, ultimately guiding the decision-making process for further development.

Preclinical Studies

Clinical trials are research studies performed on human participants to evaluate the safety, efficacy, and optimal use of medical interventions, such as drugs, devices, or treatment protocols. They are conducted in phases, each with specific goals, to ensure that the intervention is both effective and safe for widespread use.

Clinical Trials

Post-Marketing Surveillance is the practice of monitoring the safety and effectiveness of pharmaceutical products after they have been released on the market. It is crucial for identifying rare adverse effects, ensuring ongoing safety, and providing data for regulatory decisions and product labeling updates.

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