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Making unsubstantiated and/or false claims by the regulatory authorities including FDA regarding quality of pharmaceutical products

In a recently published article (link), titled “FDA Q&A: Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices” by a Senior Science Advisor, responding to a question regarding concerns expressed in a recently published book, the author of the article claims that “…Americans can be confident in the quality of the products the FDA approves.”

It is to be noted that the claim made by the FDA cannot be considered truthful and/or scientifically valid. The reason being that at present quality of the products, in particular tablet and capsule, has not be defined, thus cannot be measured or established. Furthermore, meeting compliance requirements as a substitute of “quality”, which in most cases are arbitrary, lacks validation of the suggested methods and/or procedures (both in vitro and in vivo) for their relevancy and accuracy for their intended purpose or claims (link).

It is, therefore, requested that the FDA should reconsider its claims and approaches for declaring products of having quality, and by extension safe and efficacious.

Developing a discriminating dissolution test – a wasteful practice!

Response to a recent query

I am sorry I cannot be of help because in my view, based on 30 years of research experience, as stated frequently, currently recommended and used dissolution testers  (USP Paddle/Basket) are non-validated testers for the intended purpose thus cannot provide relevant dissolution methods and/or results for any product. Furthermore developing a discriminating dissolution test, often promoted and suggested as regulatory/pharmacopeial requirement, is a scientifically flawed or invalid concept. A properly developed dissolution test by default becomes a discriminating test, however, as one cannot developed a relevant and/or appropriate dissolution test at present, thus one cannot develop discriminating test as well.

On the other hand, if you like to work with some modified version of a dissolution tester, developed in-house or as I have suggested one (with crescent-shape spindle), then there is a possibility of conducting appropriate and relevant dissolution test, which will act as a discriminating test too. I will be happy to discuss this approach in further detail if you like to explore this further.

In the meantime, the following blog article may be helpful in exploring the topic further (link).

Please God protect us from the ignorants – the regulatory/pharmacopeial authorities!

They are promoting and imposing fake science, irrelevant and invalid scientific methods, false data/statistical analyses and foolish manufacturing/inspection practices. This is also creating unscrupulous “experts” and “expertise” in the area multiplying damage to the industry as well as consumers and patients due to limited availability of pharmaceutical products and at significantly higher costs.
Stuck and suffocated!

Some relevant links: (1, 2, 3, 4, 5)

Complete disregard of science and statistics!

Some posts about Similarity Factor (F2) which is suggested for assessing quality of pharmaceutical products using drug dissolution testing.

(1)    F2 – Similarity Factor (http://www.drug-dissolution-testing.com/?p=112)

(2)    F2 – Similarity Factor (A Deficiency). (http://www.drug-dissolution-testing.com/?p=1446)

(3)    F2 (similarity factor) or a 2F (faulty facts) factor (http://www.drug-dissolution-testing.com/?p=2038)

(4)    F2 – Similarity Factor (http://www.drug-dissolution-testing.com/?p=2595)

(5)    F2 (similarity factor): An arithmetic skill-test – not a widget for quality assessment of pharmaceuticals. (http://www.drug-dissolution-testing.com/?p=3091)

(6) Similarity Factor (F2) – false and illusionary “statistics”! http://www.drug-dissolution-testing.com/?p=3222

Quality of pharmaceutical products – a quiz!

If one asks a physician and/or pharmacist inquiring whether a product prescribed is of quality; the response would be – sure. But why would it be of quality? The response would be, because it is approved by the regulatory authorities such as FDA, Health Canada and other national agencies as they assess and establish the “quality”.

Now ask the authorities the same question! Their response would be sure – because we use up-to-date knowledge and most elaborate manufacturing facilities assessment approaches for such. But the question is what is that “such”? Would you be able to equate or differentiate quality of two given “blinded products” from different manufacturers or generic vs brand name? Their answer most likely would be – well it is not that simple!

The reason being no one knows what a quality product is! It has never been defined hence cannot be determined and/or established. Period!

I have made some suggestions to address this unfortunate situation – please have a look here (1, 2) , or contact me for details at principal@pharmacomechanics.com.

Crescent-Shaped Spindle

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