Hello Manjusha Ramesh Ahire

The POC study is done to prevent new compounds from failing in the more expensive phases of the clinical trial. The POC study also known as Phase 0 comes before Phase I-IV. A POC study is designed to help the drug developer decide whether to “go ahead or not to go ahead” based on the efficacy performance of a drug candidate. In case the drug candidate demonstrates efficacy, the concept is considered proven and a “go ahead” is given from the POC study result, which means further development of this candidate drug into the Phase IIb to long term and large-scale Phase III studies.

The POC study is important for the drug candidate. The drug developer is not sure whether the candidate drug has a bright future and therefore would prefer to take up the POC study.

A generic medicine contains the same active ingredients as an original product that has been researched and developed by a pharmaceutical company. Regulatory standards for safety and efficacy are the same for generic medicines as they are for branded products. The manufacturers of generic medicines need to prove only that their products are effectively identical to the original branded product, implying that they have identical effects on patients. They need not provide any additional clinical data. But for investigational new drugs, the POC study would be necessary.

Best.

Although generic drugs in theory work in the same way as the original there is often an issue of bio-availability, depending upon how the generic was put together. Even using the same excipient chemicals may even show differences in bio-availability if they are from a different manufacturing source from the original compounds. Consequently, a POC is useful for determining if any differences have crept in due to these factors. This may save cost as, for example the US FDA Department of Generic Drugs requires randomized controlled studies with the registered Reference Drug, and setting up an equivalence study is costly.

Manjusha Ramesh Ahire

A Proof of Concept (POC) study is an early-stage clinical trial that aims to demonstrate the feasibility, therapeutic potential, or biological activity of a drug, often in a small number of subjects. It provides preliminary evidence that the drug can have the desired effect in humans before advancing to larger, more costly studies. For generic drugs, POC is typically not required since they are based on already approved drugs with established efficacy and safety profiles. However, for investigational new drugs, POC is crucial to determine if the drug works as intended and is safe. The POC study is an integral part of the drug development process, bridging the gap between preclinical studies and larger-scale clinical trials. For further reading, consider referring to "Principles of Clinical Pharmacology" by Atkinson et al. and the FDA's "Guidance for Industry: Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND."