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Stability Requirement for Clinical Trial and BA-BE

In a recent amendment to the rules, known as the New Drugs and Clinical Trial Rules, 2019. The inclusion of stability data was made mandatory for clinical trials and BA-BE testing. It is important to note that clinical trials are an important pre-requisite while filing for medical device registration in India.

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Stability Requirement for Clinical Trial and BA-BE

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  1. Stability Requirement for Clinical Trial and BA-BE In a recent amendment to the rules, known as the New Drugs and Clinical Trial Rules, 2019. The inclusion of stability data was made mandatory for clinical trials and BA-BE testing. It is important to note that clinical trials are an important pre-requisite while filing for medical device registration in India. As per table 1 of second schedule of New Drugs and Clinical Trial Rules, 2019 - “When the application is for clinical trials only, the international nonproprietary name(INN) or generic name, drug category, dosage form and data supporting stability in the intended container- closure system for the duration of the clinical trial are required.” Furthermore, the definition of Clinical Trials as per these new trial rules is as follows: Contact No: +91 7672005050 Email: contact@cliniexperts.com

  2. Clinical trial in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its: ●Clinical effects ●Pharmacological effects(including pharmacodynamics, pharmacokinetics) ●Adverse effects With the objective of determining the safety, efficacy or tolerance of such new drugs or investigational new drugs. What is stability data and its relevance here? Stability data refers to the data obtained after a stability study on a particular medical device or drug. This study evaluates the effect of environmental conditions on the quality of a drug/device with the passage of time. This data helps analyze the effectiveness of the drug or its individual composition ingredients over time. The data Contact No: +91 7672005050 Email: contact@cliniexperts.com

  3. can be used to ascertain the suitability of such drugs/devices for consumers or manufacturing processes. The necessity of stability data for clinical trials and BA/BE studies will help researchers get more insights on the composition of a drug/device so its effectiveness can be measured with respect to the stability data. Resulting in more precise and flawless reports. Additionally, it helps with the medical device registration process in some way as well. Contact No: +91 7672005050 Email: contact@cliniexperts.com

  4. What is BA and BE Studies? BA stands for Bio Availability. It is defined as the rate or degree/extent to which the major/active ingredient of a composition(drug/device) is absorbed and becomes available at the site of action. In simpler terms, BA studies define the degree to which a drug will be effective on the test subject. BE stands for Bio Equivalence. It is a term used in pharmacokinetics and is used to compare the rate and extent to which the active ingredient of a drug becomes available at the site of action in a test subject. In simpler terms, BE studies compare if two drugs can be considered the same in terms of intended purposes. The requirement of stability data will enhance these processes and result in better, precise and more informed results. If you are looking forward to medical device registration, it is always better to hire an experienced clinical trial Contact No: +91 7672005050 Email: contact@cliniexperts.com

  5. registration consultant in India for a streamlined and hassle free experience. Contact No: +91 7672005050 Email: contact@cliniexperts.com

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