Wednesday, August 28, 2013 7:59:51 PM
The Role of GLP in Preclinical Research
The role of GLP studies in drug discovery is confusing to many scientists. The confusion has two causes.
Semantic
GLP is an acronym for "Good Laboratory Practices." Hence, many scientists infer that GLP studies must therefore be "good" and non-GLP studies are of questionable quality. Actually, the "good" is more about good documentation than good science.
Regulatory Requirements
The regulatory bodies require GLP for far fewer types of studies than many scientists think. GLP requirements are for safety studies, not other types of studies.
The consequences of this confusion are that many drug-discovery organizations end up wasting time and resources on unnecessary and premature GLP studies when their objectives would be better achieved without the burden of GLP.
What Is GLP?
GLP certification was established by the regulatory bodies to ensure that research submitted to them is not only properly executed, but is also documented thoroughly enough so that any scientist skilled in the art can follow the documentation and replicate the results. The level of detail required to achieve this level of documentation is substantial — so much so that the cost of generating the documentation exceeds the cost of the research itself.
When to Use GLP
GLP is unnecessary until the final stage of preclinical development, at which point GLP documentation is needed for obtaining regulatory approval for further development.
Many researchers are under the mistaken impression that at the IND (Investigational New Drug) stage all studies must have GLP documentation. Actually, the FDA requires GLP documentation for only safety studies. This includes animal toxicity, genotoxicity, supporting toxicokinetic studies,1 and safety pharmacology.
GLP is NOT required for:
Efficacy studies, whether in vitro or in vivo.2 In fact, the IND application has no requirement at all for mechanism of action or efficacy studies.
In vitro studies, including:
Pharmacokinetic analyses that support the in vivo efficacy and toxicity studies
Drug-drug interaction studies3
In vitro ADME studies
The reasons for this are easy to understand. At the IND stage the regulators' key concern is about toxicity from exposure to the New Chemical Entity (NCE). Their goal is to ensure safety for human subjects. Other risks, such as whether the NCE is efficacious or has drug-like ADME properties are essentially commercial risks that are the responsibility of the filer. In fact, safety is core to the definition of GLP:
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, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides. 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.4
for more info, source: http://www.apredica.com/glp.php
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