From: Enigl@aol.com
Date: Fri Jan 03 1997 - 23:43:28 MST
In a message dated 97-01-03 02:36:15 EST, you write:
<<
If they do, then they should publish those statistics in a peer-reviewed
journal, search for explanations for why they work, test them under
varying conditions, and otherwise behave like scientists so that they
can /show/ us that they work, not just /tell/ us. Authority by itself
is utterly meaningless. Authorities in science g >>
The data generated by my clients is FDA reviewable for CGMP validation
purposes. Few of my clients would spend the time or money to publish and
peer review because then their competition would use my client's research to
sell their own products.
Also, many things accepted in science have not had mechanisms defined yet,
such as how preservatives act on the microbial cell. We really don't know
how they work very well, just that they seen to preserve the product without
unacceptable harm to most humans.
The few that have mechanisms were university research projects sponsored by
the government NIH or manufacturers. It is true the FDA will at least _ask_
what the mechanism is before approving most drugs during the NDA process.
They don't always get an answer.
Davin C. Enigl, MS-MEAS
President-Microbiologist
Hazard Analysis and Critical Control Point Validations
for the Food, Cosmetic and Pharmaceutical Industry
HACCP Validations (sm)
enigl@aol.com
http://members.aol.com/enigl/index.html
January 3, 1997
7:54 pm
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