Developing discriminatory dissolution tests: Who invented this nonsense [fake-science]?

A discriminatory test in general is a test or procedure which would measure a given parameter and would be able to differentiate/discriminate such between tested objects where the differences exist. A common and simple example of such procedure or routine is monitoring body temperature using a thermometer. A thermometer is placed, usually in mouth, and after bit of wait, the thermometer would provide body temperature reading. Thermometers are pre-standardized/calibrated against reference standards (temperatures). There is no thermometer or monitoring procedure developments, no discriminatory test/procedure development, no “life-cycle” variations in procedures, and no subject dependent (gender, age, race, body weight/type) procedures. Note that thermometer does not even tell if the person has fever, it only will tell body temperature which is interpreted whether the person has fever or not. Point being a pre-standardized/calibrated thermometer by default becomes a discriminatory test or tester. This is how life/science works.

Similarly, a pre-standardized/calibrated dissolution test/tester must provide a drug dissolution/release characteristic of a product (tablet/capsule). Placing a product into a vessel equipped with a stirrer with pre-set rpm containing pre-defined solvent, its volume and temperature is the dissolution test/tester. Determining drug release after pre-defined time would provide the answer i.e. drug dissolution characteristics of the product. Period! There should absolutely be no need or requirements of dissolution methods development of any type at the product/formulation development and/or their evaluation stages.

Why do we have or need dissolution method development practices including discriminatory methods – pure ignorance and incompetency of the subject. This is simply nonsense and fake-science! Be clear that at present no one is determining dissolution characteristics of any product hence its quality for which this test is conducted and promoted.

Seek sensible and scientifically valid solutions! (1, 2, 3, 4)

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