How to design a drug whole procedure step by step done in pharma industry with examples

How to design a drug whole procedure step by step done in pharma industry with examples

The process of designing and developing a new drug, also known as drug discovery and development, is a complex and multi-step process that typically involves the following steps:

Identifying a target: The first step in drug discovery is identifying a target for the drug, such as a specific protein or enzyme that is involved in a particular disease process.

Screening compounds: Once a target has been identified, researchers will screen large libraries of compounds to identify those that show promise as potential drugs. This typically involves testing the compounds in cell-based or animal models to determine their effectiveness and safety.

Lead optimization: From the initial pool of compounds that show promise, researchers will select a "lead compound" and then work to optimize its properties in order to improve its effectiveness and safety. This can involve chemical modifications or other changes to the compound.

Preclinical testing: Once a lead compound has been identified and optimized, it will undergo preclinical testing in animal models to assess its effectiveness and safety.

Clinical trials: If the compound is found to be effective and safe in animal studies, it will move on to clinical trials in humans. These trials are conducted in three phases: Phase 1 trials involve a small group of healthy volunteers and are designed to assess the safety and dosage of the drug; Phase 2 trials involve a larger group of patients and are designed to assess the effectiveness and side effects of the drug; and Phase 3 trials involve an even larger group of patients and are designed to confirm the effectiveness of the drug and monitor any side effects.

Regulatory approval: If the clinical trials are successful, the drug will be submitted to regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, for approval.

Manufacturing and distribution: If the drug is approved, it will be manufactured and distributed to patients.

As an example, let's consider the development of an antipsychotic drug. Antipsychotic drugs are used to treat schizophrenia and other mental disorders characterized by psychosis, such as bipolar disorder. The first step in the development of an antipsychotic drug would be to identify a target, such as a specific receptor in the brain that is involved in the symptoms of psychosis. Researchers would then screen compounds to identify those that show promise as antipsychotics, and then optimize the properties of these compounds through lead optimization. The resulting compound would then undergo preclinical testing in animal models and, if successful, move on to clinical trials in humans. If the clinical trials are successful, the drug would be submitted to regulatory agencies for approval and, if approved, manufactured and distributed to patients