Hi Anonymous,
Nonclinical and Preclinical are often used interchangeably. However, technically, "nonclinical" studies are those that are not clinical studies. They are not studies that are just in animals, as you state, but they may able be in other test systems. "Test system" is a Good Laboratory Practice (GLP) term that is basically the animal, microorganism, plant, etc. that you are testing the test article on. Nonclinical studies are discussed in the GLPs.
"Preclinical studies" are the same as nonclinical, but are done (technically) prior to performing clinical trials.
If these are headhunters looking for GLP Consultants, I find it distressing that they are looking for someone who has no GLP experience. One cannot simply take a GMP or GCP auditor, for example, and have them do a GLP audit without proper training. There are so many facets to the GLPs that one needs to learn before performing an audit. GLPs are not black and white. One cannot simply read the regulations and claim that they are familiar with the GLPs. There are so many shades of gray that the GLP Auditor must know. These are accomplished by education, training and experience... as is stated in the GLPs. Most of the GLP auditors that I know regularly attend the Society of Quality Assurance (SQA) meetings where we have direct access to the FDA regulators and Inspectors. Many of the FDA personnel also give talks or open mic sessions which yield a wealth of knowledge and current thinking for the GLP professionals.
As to your comment about GLPs not applying to a GMP or GCP setting, that is not quite accurate, as more of these labs are claiming that they are GLP, so it would apply to them. And here's why I state that. For GMP labs: At the last SQA meeting, we were reminded that if the test article is not prepared according to GLPs, we have to take an exception to the GLPs in our reports (we knew this part already). The FDA is cracking down on the Study Director just accepting a C of A as proof of the identity, strength, purity, composition, etc. of the test article. They want to see that the Study Director has seen the data supporting this, and other aspects of the test article manufacturing. Therefore, as a reaction to this. more and more GMP labs are asking for GLP training, and incorporating GLP aspects in their lab. I just trained GMP personnel at a lab a couple of weeks ago, and am routinely getting requests for GLP training from GMP labs. For the GCP aspect... the analysis of bioanalytical samples from human trials are being conducted according to GLPs in many labs. Otherwise for human GCPs, that's all I see. However, for the FDA's CVM studies for animal pharmaceuticals, devices, etc., GLP studies are routinely conducted, and I get many requests for GLP audits of this sort.
Also, the FDA 21CFR 58 is more than just a "requirement". They are a regulation, a law, and must be followed in the USA.
I hope that this helps answer your question.
Best regards,
Robin
Robin Guy, MS, DABT, RQAP-GLP
Robin Guy Consulting, LLC
Toxicology and GLP Consulting
Lake Forest, IL, USA
robinguy@robinguy.com
1.847.295.9250
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Original Message:
Sent: 08-Jun-2018 12:02
From: Anonymous Member
Subject: Preclinical vs. Nonclinical
This message was posted by a user wishing to remain anonymous
Hello,
This is a very basic question, so my apologies if it is a duplicate of any thread.
The question is, do preclinical and nonclinical indicate the same type of study? For example, preclinical studies are those performed in laboratory and in animals prior to being used in a clinical setting, whereas nonclinical are the same types of studies (animal/laboratory) performed at any time during the drug development process.
A little background: I have been approached about auditing for "Nonclinical Studies" per 21 CFR 58. Now, my original understanding was that these "GLP" requirements were focused solely on animal study laboratories and not intended to be applied to a GMP/GCP setting. Simply, these are solely for animal testing laboratories, even though they imply a general laboratory application (GLP). Unfortunately I am seeing a great deal of miscommunication between industry and those hiring for positions so I am attempting to clarify this for head hunters, and so forth. I want to make sure I am properly explaining when I am approached about these types of positions, and not confusing the issue. My background is mostly pharmaceutical GMP/GCP auditing, though I have extensive laboratory and medical device QA experience as well.
Thank you!