GLP guidelines are readily available on the internet.
Here's a commonly found description:
Good Laboratory Practice (GLP) embodies a set of principles that provides
a framework within which laboratory studies are planned, performed,
monitored, recorded, reported and archived. These studies are undertaken to
generate data by which the hazards and risks to users, consumers and third
parties, including the environment, can be assessed for pharmaceuticals (only
preclinical studies), agrochemicals, cosmetics, food additives, feed additives
and contaminants, novel foods, biocides, detergents etc.... GLP helps
assure regulatory authorities that the data submitted are a true reflection of
the results obtained during the study and can therefore be relied upon when
making risk/safety assessments.
For EPA guidelines, see:
http://www.epa.gov/oecaerth/monitoring/programs/fifra/glp.html
Pay particular attention to 40 CFR, Part 160, FIFRA.
Other agencies have GLP guidelines - all have the same purpose
There are some differences btw FDA, EPA, and OECD. Those are summarized
at:
http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135197.htm
I hate to quote a Wiki entry, but this one is pretty close to the truth:
....academic scientists perform a wider range of basic/exploratory
experimental research to: identify unknown potential hazards of chemicals,
elucidate the mode/mechanism of action for known toxicants, and explore novel
toxic endpoints. Accordingly, their experimental methods vary greatly in the
delivery route of the test chemical, the number of test animals and the range
of doses. These test methods are far more varied than the GLP test
protocol is; and (at least before peer review) academics do not like to share
their results or methods with laboratories competing for grant money or to give
insight in raw data produced. These factors make it hard for regulatory
agencies to use the results of academic researchers in chemical risk
assessment.
Where I disagree with the Wiki entry is when this statement is followed
by the argument that regulatory agency's "universal requirement that
toxicity studies be performed according to OECD/GLP protocols automatically
excludes the toxicity results of the independent researchers".
"The latter's methods, though variable, do test more realistic doses than
the OECD protocols use".
These statements are just wrong. Nothing in the GLP protocols tells a
researcher what dose levels to use. Nothing prevents use of alternative
methods. But, if you use an alternative or new method, you have to show how you
are going to monitor and assess performance. That's why one starts by
drafting a Work Plan that lays this out.
I consider this part of the Wiki entry as a convenient excuse used by
some academics who do not want to bother themselves with following established
principles. Don't get me wrong - not all research, especially exploratory
research requires a full-blown GLP approach. But, if you are going to use
your results to affect risk/safety assessments and decision making - you
have to up your game. And, yes; adding GLP ups the cost.
But do you really want to assume that just because an investigator
calculates a dose, that is the dose delivered? I can tell you from years of
experience, the dose is rarely exactly what one calculates, and a simple math
error or measurement error can make a huge difference (often its a misplaced
decimal point, so the dose can easily be an order of magnitude above or
below the target). Even when all of this is correct, issues such as matrix
interferences can skew results. Only one way to know that the dose one
intends to deliver is in fact the dose delivered - analysis. That costs
additional money; but its a necessary step.
Jerry
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