Application Of Pharmacokinetics In Early Drug Development

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Application Of Pharmacokinetics In Early Drug Development

Pharmacokinetics holds the true essence of drug development in the early stages as it acts as a determining factor for any drug to be manufactured and marketed.

Drug development is a multifaceted process that includes sub-processes. While there are so many aspects to look into pk study stand out among most of these methods. The simple reason is it gives the results which are then used to develop the drug and move on to the manufacturing process. Pharmacokinetics is the study of how the subject’s body, participating in the study reacts to the drug.

What Is The Use Of Pharmacokinetics In Early Drug Development?

In early drug development, pk analysis is extremely crucial, and it shows how the drug has been accepted or rejected by the subject. Early on during the drug development process, these results further initiate clinical trials which would provide a concrete basis for furthering the development of the drug or bring in any suitable changes necessary.

Different Phases Of Pharmacokinetics Used In Early Drug Development

While the understanding of how pharmacokinetics works in early drug discovery and development process is essential, it is also equally important to understand the multiple phases that a pk clinical trial involves.

Phase 1

At this stage, mostly a small number of healthy subjects are chosen, and the drug is administered in small doses. This is the most basic level of the entire process but can also act as the determining factor depending on the drug type and its reactions.

If deemed necessary, the doses can be slowly increased to therapeutic and super therapeutic doses which can help further the study. The knowledge about the drug and its efficacy gathered in this phase of pk study is then used as information in Phase 2 and Phase 3.

Phase 2

This phase is carried out to ensure that a drug tested in Phase 1 continues to be safe or not for subjects. The aim for this phase of the pk clinical trial is to determine whether or not the drug will be safe to use for those suffering from the disease which the drug is meant to target.

This phase is considered to be one which provides evidence for the safety and efficacy of the drug. It also serves as a platform to encourage sponsors for financing further development of the drug.

Phase 3

This phase steps out among the rest, firstly because of the large sample population it involves and secondly for its aim to look for adverse effects. This study holds the pk assay initially provided from phase 1 and 2 and takes the approach for finding rare effects of the drug on a broader range of the population.

The search for adverse effects does not stop with the information pk analysis provides. Instead, it furthers into several other approaches to see how it is different from the drugs available in the market.

The importance of pk assay in the early stages of drug development is not merely another fundamental approach but a very essential one. Without pharmacokinetics and the valid data, it provides for drug development, many drugs that are in use today wouldn’t have seen the light of the day.