How Drug Discovery Programs Advance From Idea to Approval?

Drug discovery is a multidisciplinary phenomenon that includes a considerable number of stages. Right from an idea to submission for approval, a drug candidate goes through numerous phases of integrated drug discovery. The major stages of drug discovery are as mentioned below.

• Target Discovery
• Hit Generation
• Hit Confirmation
• Lead Optimisation
• Preclinical & Clinical Development

How a Drug Discovery CRO Proceeds With a Project?

A prominent drug discovery CRO offering drug discovery biology services comprises a team of scientists who are well-positioned to tackle the diverse drug discovery needs. Their chemistry and biology experts become an extension of the sponsor’s R&D teams, coordinating and guiding them through the discovery needs right from study design to interpretation of data, from screening to medicinal research, and so on.

Major steps followed during drug discovery projects at drug discovery laboratories are as follows:

• Basic Research on Idea: Long before a new drug can even be imagined, scientists need to gain a basic understanding of a disease. When a potentially relevant target for an identified disease is validated, scientists then proceed to search for chemicals that might affect the target by screening vast compound libraries. This process can be divided into three major categories.
  • Development of large compound libraries
  • Specific assay development
  • High-throughput screening

• Preclinical Research on Medicine: Once a promising drug compound is identified, preclinical studies are performed by scientists at CROs to evaluate a drug’s safety, efficacy, and potential toxicity in animal models. Preclinical development solutions are one of the earliest and most prominent drug discovery stages that define the course of success of drug candidates.

Preclinical studies significantly help researchers to design Phase I studies to be conducted with humans. It helps in determining the initial dose to be utilised in the clinical trial to identify safety evaluation parameters. The result of work at this stage is a pharmacological profile of the drug that will be beneficial for the drug's success.

• Phase I Clinical Trials For Safety: Phase I trials are the first instance during drug discovery when a drug is tested in humans. In this stage, the experts get to know about a drug's effect when it is administered with another drug, the drug’s pharmacokinetics to understand a drug’s actions in the body, the acceptability of the drug’s balance of potency, pharmacokinetic properties, and toxicity.

• Phase II Clinical Trials For Proof of Concept: During this stage, the drug is tested for the first time for its efficacy in patients with the disease or the condition targeted by the respective therapeutic agent.

• Phase III Clinical Trials For Regulatory Proof: This stage of clinical trials is designed to anticipate the candidate drug’s effect and prove the ultimate benefit in a large targeted patient population with the disease. It confirms efficacy, monitors side effects, and often compares the respective drug to other popular treatments.

• Phase IV Clinical Trials For Marketing and Safety Monitoring: These trials are conducted after a drug receives regulatory approval from the FDA. It is done to gather additional information regarding a drug’s long-term safety and efficacy, including its risks, benefits, and optimal use.

Get Meticulous Drug Discovery Biology Services From Integral Biosciences

Integral Biosciences is a well-equipped modern drug discovery CRO based in India. It has a perfect blend of knowledgeable scientists and the latest technology to ensure program efficiency, timely communication, and rapid turnaround time. Collaborating with IBS means taking a firm step towards the success of your drug discovery project. Connect with IBS now.

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Created on Mar 24th 2022 01:26. Viewed 196 times.

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