[As part of a discussion on the LinkedIn Network group (Pharmacokinetics), I posted the following response. For the interest of those who do not participate in the LinkedIn Network, or the particular group, I am posting the response on this blog as well. I hope that you will find the post useful.]

Thanks again Simon: [Simon’s post is attached at the end of my response]

I do not think we are going in circles, but in my opinion, you are either not following my point or avoiding it. Let me explain it another time.

“The aim of IVIVC is to Predict in vivo behavior from in vitro data.” This is incorrect. As the name (or “C”) implies, it is not a prediction exercise, but exercise in developing a correlation. For IVIVC, one has to have in vitro (i.e. dissolution) data as well as in vivo (plasma drug levels) data, and to relate them. No prediction what so ever.

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Before using any tester, it is commonly understood and often in fact is a requirement to establish that the tester is capable of measuring the expected parameter or characteristics. For our purpose, prior to its use, the apparatus or tester must be shown that it is capable of providing appropriate dissolution characteristics (i.e. percent drug dissolution at times) of a pharmaceutical product. There are different ways of saying the same thing, for example:

The tester is capable of measuring the dissolution characteristics with the required precision; the tester is fit for its intended purpose; or the tester is qualified and validated for its intended purpose.

A usual practice for establishing the “fit-for-purpose” or performance of a tester would be to determine dissolution characteristics, with its associated precision, of a reference product. If the tester provides the dissolution value, with required precision, then the tester will be considered as qualified and validated. Continue reading →

The above title is self-explanatory, clear and says it all.

People have to be careful when offered help in developing and/or validating dissolution methods based on non-validated apparatuses (e.g. paddle/basket) and/or experimental conditions. The results obtained would not be of any use, even for QC purposes, no matter how they are presented.

The following links may be of further help in this regard. Continue reading →

For further details please see the following links:

1. A Simple and Unique Approach for Developing and Evaluating Products (link)
2. Assay and Content Uniformity (CU) based on dissolution testing (Poster Presentation). (link)

Some more relevant links:

• The science of drug dissolution testing: Testers or apparatuses, experimental conditions and interpretation of results – A systematic approach for learning. (link)
• Selecting a Dissolution Apparatus – Some Practical Considerations. (link)
• Drug Dissolution Testing Using Simple and Common Experimental Conditions (link)
• One Step (Product Evaluation) Approach (link)
• Can a dissolution test be used for assay and content uniformity testing? Of course! (link)