Pharmaceutical regulatory science sem8 (unit1) notes

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New drug discovery and development is the process of identifying, designing, testing, and bringing to market new medications that can treat or cure diseases. It involves a broad range of activities, including basic research, clinical trials, and regulatory approval.

The process of discovering a new drug typically starts with the identification of a disease or medical condition that currently lacks an effective treatment. After identifying the target disease, scientists conduct extensive research to better understand the underlying biological mechanisms of the disease and identify potential drug targets.

Once a drug target has been identified, drug designers create and test numerous chemical compounds that may interact with the drug target. This process is called drug screening, and it involves testing thousands of compounds to identify one or more that have the desired effects on the target.

Once a compound has been identified as a potential lead, it undergoes further optimization to improve its potency, selectivity, and safety. This process can involve modifying the chemical structure of the compound or conducting additional screening of analogs or derivatives.

After the lead compound has been optimized, it is evaluated in preclinical studies to determine its safety and effectiveness in animal models. These studies provide important data on the drug’s pharmacokinetics (how it’s absorbed, metabolized, and excreted by the body) and toxicity (its potential side effects).

If the drug passes preclinical testing, it moves on to clinical trials, which are conducted in humans to evaluate safety and efficacy. Clinical trials are typically conducted in three phases, with each phase involving increasingly larger groups of patients. Clinical trial data is then submitted to regulatory agencies for approval, which involves a rigorous review process to ensure the drug is safe and effective for its intended use.

Finally, once the drug has been approved by regulatory agencies, it can be marketed and distributed to patients who need it. Ongoing monitoring and clinical trials may be conducted to ensure the drug continues to be safe and effective over time.

In summary, new drug discovery and development is a complex and highly regulated process that involves a diverse range of scientific and regulatory activities. It can take many years and cost billions of dollars to bring a new drug to market, but the benefits to patients and society can be enormous.