Drug Discovery Design And Development – A Journey From Lab To Market!

Drug discovery design and development is a high-risk and expensive endeavor. It takes on average 10-15 years and around $1.5 billion to develop a new prescription drug. The major obstacle to the drug discovery process is a high attrition rate. Studies estimate that only 1 out of 10 drugs that enter clinical trials are developed into a novel drug product.

Developing a novel drug product is a significant task. It becomes even more challenging for players  recently introduced to drug discovery and development. Developing drug compounds need thoroughly validated bioanalytical techniques such as the lcms method and immunoassay. Although there are CROs and LC-MS labs to help develop and validate bioanalytical methods.

Each developed drug product must be productive and safe for the patient population, and sponsors must demonstrate its efficacy across different age groups and ethnic and racial groups .. Besides, each drug product must pass a thorough regulatory review. Once regulatory bodies approve a drug product, the drug must appeal to the patient population, distribution systems, and healthcare systems. This article is a mini-review of the drug development timeline.

Drug discovery process

Generally, a prevalent medical need drives the interest in selecting a therapeutic area. However, additional factors such as developmental costs, commercial considerations, and technical feasibility are also considered. Besides, each company has its project priorities. Hence, developing a drug product depends on the availability of a research budget aligning with project priorities.

Pre-clinical studies

Earlier lead compounds were selected from natural sources. But today, many lead compounds are synthesized directly in laboratories. Besides, modern screening techniques use virtual screening to test a large library of potential drug compounds. Once promising candidates are selected, sponsors test them for selectivity and potency through several in vitro cellular and biochemical assays. These assays are followed by in vitro and in vivo pharmacological and functional biochemical testing. Finally, pilot toxicology testing is conducted to assess the safety profile and decide whether to transition the compound to the clinical phase.

Clinical phase

Clinical trials are the first-in-human studies. This stage is where a drug is scaled to meet compound demands. Generally, clinical trials consist of three phases, Phase I, II, and III. Let us dive deep into these phases individually. 

Phase I studies begin with testing the drug in the human population. Generally, healthy volunteers are considered for Phase I trials. However, cytotoxic drugs are an exception. The primary purpose of Phase I trials is to assess drug safety, PK/PD parameters, and tolerability.

Phase II studies include testing in the patient population. This phase studies the safety and efficacy of the drug product in the target patient population.

Phase III studies confirm frequencies, doses, and time of drug administration. It generally includes numerous target patients to have an adequate database of safety and efficacy profiles.

Life Cycle management

Only after regulatory approval a drug reaches the patient population. Even after entering the market, sponsors must assess the safety and efficacy profile. Such monitoring can help sponsors study and apply for a supplemental new drug application.

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