Best Practices to Follow for Preclinical ADME/PK Studies


When we talk about the process of drug discovery, there are a lot of tests and stages of evaluation that take place before the drug can be ready to reach the market. One of the important testings involved in the whole procedure is the Absorption, distribution, metabolism, and excretion (ADME) studies that should be done in the preclinical trials to explore the journey of a compound through the body.

It has been found that incorporating ADME/PK testing in the preclinical trials can reveal safety problems in the drug that may lead to delay in the launch of the drug, drive up costs, and risk outcomes. This is why preclinical ADME/PK testing is important from the safety point of view and it also saves time and money.

However, most sponsors that support pharmaceutical companies in such trials don’t carry out the ADME/PK testing on time, which may have repercussions. This is why, opting for preclinical CROs that offer ADME DMPK services is a preferable option as they prioritize these testings and carry them out at the right time.

What are the benefits of early ADME/PK testing?

When it comes to ADME/PK testing the best practice to follow is to carry out these testings in the early preclinical stages as it will reduce the safety risks and also strengthen the approval odds of the drug. 

Having an early ADME study report also means that you have enough evidence to go forward with other testing and trials of the drug. It has also been found that between 1991 and 2008 the PK failures reduced from 40% to 1% as a result of early ADME testing. This was very beneficial as researchers got the idea whether the compound they are testing is worth going forward with, or not.

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With early ADME testing you can detect the problems in the compound before it faces the FDA. This increases its chances by getting FDA approved without facing any scrutiny. ADME testing, done at the right time prevents many regulatory problems and reduces the risk of failure. 

When ADME studies are not done on time, researchers have to carry them out in the later clinical stages when they get more expensive and complex. This is why choosing sponsors like Jubilant Biosys that prioritize ADME services are important.

Why is delaying the ADME/PK studies not recommended?

When ADME/PK studies are delayed, it often leads to clinical failure of the compound which could have been easily avoided if these studies were done on time. The testings are also important for the safety of the patients and not performing them in the preclinical stage may lead to a number of health issues in the patients.

Delaying the ADME/PK testing just means that you go through many other additional testings, which could have been avoided. This exhausts both money and time. It may also cause delays in the approval of the compound and delay the whole drug discovery process.

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