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...

Much of this blog involves a critical analysis of
hypotheses regarding the biological basis of behavioral sensitization.

Research on this question has focused on mesotelencephalic DA systems, and suggestions that behavioral sensitization is accompanied by:

(1) an increase in postsynaptic DA receptors;


(2) an increase in DA synthesis; (3) an increase in DA utilization and/or release; and


(4) a decrease in DA...

Two profoundly concerning issues with respect to generic companies receiving approval for their product


1) What is even more interesting (and, in my opinion, both unacceptable and unethical) is the "testing process" which a generic company completes in order to complete the application (an ANDA) to the FDA, for ultimate approval. Here is what I mean:

1) The generic company --alone-- performs all the tests to ensure it is commensurate with the Brand...