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Drug Discovery and Clinical Evaluation of New Drugs

The process of discovering and developing new drugs is known as drug discovery.

What is Drug discovery?

The process of discovering and developing new drugs is known as drug discovery. It involves a series of steps that begins with identifying potential drug targets and end with the approval of a new drug by the Food and Drug Administration (FDA).

This can be done through a variety of methods, including studying natural substances, synthesizing new compounds, or modifying existing drugs.

The goal of drug discovery is to find new treatments that can be used in humans safely and effectively.

Scientists and researchers work tirelessly to find new and innovative ways to treat diseases, and their efforts often result in life-saving medications.

Methods of Drug Discovery

1. Screening

The most common method of drug discovery is screening. This involves testing thousands, or even millions, of compounds against a disease target to see if any of them have the desired effect.

2. High-throughput screening (HTS)

A type of screening that can test very large numbers of compounds in a short period of time.

3. Target-based approach

This involves designing drugs that specifically target a particular disease-causing protein.

Clinical Evaluation of New Drugs

A new drug undergoes a series of rigorous tests before it is accessible to the public.

The drug discovery and clinical evaluation process is complex, and it can take years for a potential new drug to make it to market.


Drug Discovery Phase

  • This phase involves the identification of a target molecule.
  • This target molecule is studied to see if it has the potential to be a new drug.
  • Once a target molecule is identified, scientists work to design and synthesize a compound that can bind to the target molecule.
  • This compound is then tested for its ability to bind to the target molecule and for any potential side effects.

Pre-Clinical Evaluation Phase

  • This phase involves studying the target molecule to see if it has the potential to be a new drug.
  • In this phase, scientists work to identify a compound that can bind to the target molecule.
  • This compound is then tested for its ability to bind to the target molecule and for any potential side effects.

Clinical Trial Phase

  • This phase involves giving the compound to a group of people to determine if it is effective.
  • In this phase, scientists work to identify a compound that can bind to the target molecule.
  • This compound is then tested for its ability to bind to the target molecule and for any potential side effects.

Phases of Clinical Trials

  • The Food and Drug Administration (FDA) reviews new medicines after they have passed through all three phases of clinical trials and have been determined to be safe and efficient.
  • The FDA then reviews the data from the clinical trials to make sure that the drug is safe and effective.
  • However, even after a drug is approved by the FDA, it is still subject to ongoing review by the agency. This is known as pharmacovigilance.
  • Pharmacovigilance is the ongoing monitoring of a drug’s safety and effectiveness after it has been made available to the public.

Process of Pharmacovigilance

1. Identification of a potential problem with a drug:
This can come from many sources, such as reports from health care professionals, patients, or the manufacturer.

2. Evaluation of the problem:
This involves looking at all of the available data to see if there is a real problem with the drug.

3. Assessment of the risk:
This involves determining the severity of the problem and the likelihood that it will occur.

4. Communication of the risk to health care professionals and the public:

This involves alerting people about the potential problem and recommending what they should do if they are taking the drug.

5. Evaluation of the response:
After the risk has been communicated, it is important to monitor the situation to see how people are responding and whether or not the problem is getting better or worse.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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