Quality – 2019 & beyond!

Hopefully the year in which “quality pharmaceutical products” will be defined along with their measurable standards/specifications so that manufacturers worldwide would be able to manufacture such products efficiently and economically. Please follow the link for more details (1, 2).

An interesting question about drug dissolution testing and simulation/modelling:

In the life cycle of drug product development several types of biorelevant dissolution data are generated (single stage, 2-stage, ASD etc.) to aid formulation development. These dissolution data are also used in PBPK models.

What type of in vitro biorelevant dissolution methods do you use as input in PBPK modeling?

Can there be a general decision tree on the use of types of biorelevant dissolution data in PBPK models for applications in formulation selection?

Very good question!
In this respect, one should make sure that apparatus/method used for dissolution testing purposes should be validated first. It is important to note that at present none of the apparatuses/methods have been validated. For validation purposes the apparatuses/methods are to be validated independently using a reference product with known dissolution characteristics which then should be applied to the test products. Scientifically validation cannot be achieved using products under development (http://www.drug-dissolution-testing.com/?p=3126).

Should claims of quality of approved and marketed drug products be considered valid – not necessarily? Theranos’ style regulatory and pharmacopeial claims!

A product can only be considered of quality, and by extension safe and efficacious, if it meets specification(s) directly linked to a defined quality property/parameter. As, at present, a quality parameter for pharmaceutical products such as tablet and capsule, is undefined thus it is not possible to make valid claims in this regard.

Current regulatory and pharmacopeial approved products available on the market should only be considered as compliant to arbitrary standards/specifications, mostly invalid and irrelevant for quality. Claims are unsupported – a similar scenario as observed in the case of Theranos (link). Please use caution is making or accepting such claims, and seek appropriate help in addressing the issue (link).

Dear regulatory authorities:

Please consider defining a quality product along with its measurable parameter which will make most of the current regulatory requirements and practices unnecessary resulting in efficient manufacturing and significant cost reductions. Please follow the links for further details (1, 2)

“Regulatory (pharmaceutical) science” – lacks logic as well as science!

One cannot establish quality of anything without knowing or defining it first. This is simple logic!
Regulatory authorities including pharmacopeias, however, have been trying to prove this logic wrong! That is, they have been making claims of establishing and monitoring quality of pharmaceutical products such as tablet and capsule – without knowing or defining it. Obviously, they will fail and have been failed!
Logically and/or scientifically, none of the products (approved or otherwise) available on the market can be considered of quality. Guidance and compliance-based system, along with the plant inspections, is a thick smoke screen hiding the reality and hindering the progress.
Please, define a quality product and set the standards and specifications accordingly so that appropriate quality products could be manufacture and monitored. For further detail, please see here.

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