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Just Some Thoughts

Posted 01-21-19 at 01:55 AM by wonderboy
Here is what I personally noted, and it also seemed to be the consensus of many others writing opinions on the net.

Between the years of 2007 - 2012, my favorite generic Adderall IR was BARR

It was my favorite because it seemed to have strong efficacy and balanced and smooth.

I remember, between these years 2007 - 2012 it was not only myself writing accolades; it was praised, it appeared, by most, online.

Sometime after Teva took over for Barr, I noticed a very marked decrease in potency and efficacy, and noted this same criticism from others.

Hilariously, Brand Name Adderall IR (at that time) was produced by TEVA, as well as, Generic Adderall IR.

There is a possible explanation for this.

If you notice the "markings" on Teva's Generic Adderall IR - Let us say the 30mg tablet are:

b 974

I believe that during this time, the Brand Adderall IR, while manufactured by Teva, it was actually produced in labs by BARR.

Teva's Generic IR I think (at that time) was manufactured by a drug company called Duramed Pharmaceuticals, as they are a subsidiary of BARR

Something, I personally believe, has improved in Teva's Generic IR.

Although it is not like it once was, it has, when compared to others, more potency and efficacy. I do not know what role BARR or Duramed may play in Teva's product today, I do know that Barr does not --directly- manufacturer GENERIC IR. (Please correct me if I am wrong, but Barr, although may be a producer, it is no longer a producer)

Today it seems there are a kaleidoscope of generic companies filling petitions with the FDA to manufacturer their generic D-Amphetamine Salt Combo IR

WHAT MOST DO NOT KNOW ABOUT HOW GENERIC COMPANIES "TEST"
__________________________________________________ _____________

1. There is not a FDA representative required to "directly" oversee the generic company's test (ie they are not --there-- in the lab) so to speak

And while the FDA mandates certain standards that generics (applying for approval of their product) must undertake, they do not act as a "babysitter" so to speak

What I am getting it is this:

Like cheating on a algebra test, the teacher (here the FDA) may not catch you... But obviously, you must complete the test, and, turn in your test.



Another concern - And this effects the "EXTERNAL VALIDITY" of a firm's tests

A. They may have a very small sample size >25

B. The samples may not be "vetted" with absolute accuracy:

1. Some "samples" may, at the time of the test, be taking other medication, or, have other psychiatric / neurological conditions

**C. There may be, in the total sample size, more of a certain age group, demographics, or races tested

These may seem irrelevant, but they could very well produce data that has very poor "External Validity"



Here is a interesting note: FDA WAIVERS

If the generic company can prove, through testing established by, analyzed by, and conducted by the company, that -- let us say their 30mg tablet is completely bioequivalent to the Brand Name, in terms of the time the drug is detected in the blood, the highest level detected (with the time recorded) and, the time the drug leaves the body, are, in FDA standards "Bioequivalent" to the Brand Name, the generic company can request a "WAIVER" in terms of testing their lower strength tablets, arguing that because, their highest MG (let's say 30mg tablet) was shown as "bioequivalent" - then - if each method is (or were) implemented by the generic company, it would, obviously as well be Bioequivalent.

Waivers are profoundly concerning, and consist of fallacious research testing standards.

Now: Would it be worth it for the generic company to use substandard testing 'methods....well, if that were to save them, a literal fortune, who knows?


The real danger, however, is not necessarily when the product they tested, and given to FDA to demonstrate acceptable equality to the Brand...

Conversely, it is when the "ACTUAL FORMULA" is on conveyor belts, and the firm must actually "make" what they "tested"

Now...is it worth it at --this stage-- for a generic company to, "cheat" let us say...

Not really

Because if caught, they could face a absolute fortune in fines and penalties, but their entire pipeline of drug could face immediate "search and seizure" by the FDA

But...the FDA is, in my opinion, grossly understaffed, to conduct surprise evaluations of the firms warehouse and manufacturing process, but most of these are ----actually--- in Third World Countries

There is a very good reason firms have most of the drug made there.

Just my thoughts...
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