PK Clinical Trial During New Drug Discovery and Development – An Overview

PK Clinical Trial During New Drug Discovery and Development – An Overview Drug research, as conducted on human subjects, and is referred to as the PK Clinical trial during drug development and testing. It generally constitutes of four distinct phases, and each one comprises different kinds of clinical analysis and studies. However, these four phases do not include the entire study and research of the new drug.

Typically, drug research aims to find answers to various questions, such as the side-effects and effectiveness of the drug. These questions are answered with a PK study​, which helps determine information about the drug, using blood samples from different patients, over a fixed period of time.

But, let’s look at the different PK clinical trial phases scientists conduct during Drug research and development.

PHASE I Phase One, generally written as Phase I, are the trials conducted on a small number of patients usually up to 10 patients.

The PK analysis in this Phase aims to find out:

● The safety of the drug at the administered dose. Different doses are tried as well in smaller groups. ● Its side effects on the patient. Researchers conduct many blood tests for this very reason. ● The body’s mechanism to get rid of the drug. ● The effect on the site of action.

PK assay, over a more extensive range, tries to find out the drug’s ability to correlate to its effects (therapeutic or adverse) with exposure and helps characterize the drug-drug and drug-disease relationships if any.

PHASE II Not every treatment tested in Phase I of a PK clinical trial makes it to the next one. This trail widens its study to up to 100 patients.

Phase II aims to find out:

● The surety and effectiveness of the new drug is examined. It determines if the drug is ready for testing in a larger group in the next Phase. ● The drug’s effect on different kinds of the same illness (for example, cancer). ● More information about the side effects and their treatment. ● More information on the right dosage. Phase II trials are normally longer than Phase I. Some Phase II trials are even randomized.

PHASE III By the third trial, the new drug already goes through a rigorous process of testing and falls under a standard treatment scheme. During this phase, up to 3000 patients are involved in testing.

The Phase III trials aim to find out:

● Which drugs work better for a particular type of disease/illness. ● More on the side effects. ● The effect of the treatment on the patient’s quality of life.

The standard treatment can be compared with:

● A new kind of treatment. ● Different doses administered for the same treatment. ● Frequency of the drug administration for effective results.

● New ways of administering standard treatment (Radiotherapy for example).

The number of patients involved in this stage is more. Therefore, the differences in success rates may be fluctuating.

PHASE IV The Phase begins after FDA approval, allowing doctors and specialists to recommend the drug to patients. A series of trails are conducted once the drug is licensed and active in the market.

The last trails of Phase IV aim to find out the:

● Long-term benefits and risks harbored from the treatment. ● Effectiveness of the drug when used on a larger scale.