1. When a generic firm resolves to submit a application for a generic medication, it is the firm, not the FDA, that conducts clinical tests to confirm that their product is bioequivalent
to the brand name drug.


PROBLEM #1: POOR EXTERNAL AND
INTERNAL VALIDITY


External validity is the degree to which findings from research, tests, and statistical analysis can be accepted as reliable to a broad array of the population.

...

Non-Verbal Learning Disorder:
Does the overlap autistic spectrum disorder?

The Work and Writing of Byron Rourke


http://www.nldline.com/michaelr.htm

NOTE: NVLD is not included in the DSM


"Characteristics"


"The impairments related to a nonverbal learning disability manifest themselves in seven main categories of deficits:


Visual-spatial—difficulty with visual-spatial...

Invariably for every positive review of a generic, you will find a negative review.

The problems outlined



When the generic firm decides to produce a product and submit a ANDAto the FDA, The bioequivalency testing is conducted by the firm, with very little oversight by the FDA.



A. POOR EXTERNAL VALIDITY:


When generic companies conduct tests concerning bioequivalency, they may only have less than...

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To the immense, though, as it shall turn out eventually, premature relief of our Champions of Brutish Macho-Musicianship, there came Q. D. Barrington walking up to their cell's door, with jangling key ring. He proceeded to unlock the door of their cell.

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One fine day, the infamously bloodcurdling rock act Kiff was strolling down Lambeth Road, doing the Lambeth Walk, or, as the case might be, to the degree their Scary Outfits allowed them to.

Passers-by reacted appropriately: elderly ladies shrieked and hid themselves, Japanese tourists took pictures, and someone from Inverness had jumped into the Thames. As might be expected, all this had attracted the attention...