What is the difference between nonclinical and preclinical studies? Autor de la hebra: Roman Shchadnov
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As a medical translator, I was recently asked about the difference between two terms: “nonclinical study” and “preclinical study”. Unfortunately, I was not able to provide the answer, because I could not find any regulatory documents in which these terms were clearly separated.
As far as I can gather, these terms are very similar (both mainly refer to animal studies with a similar purpose), but the term “preclinical study” refers to a study performed before a first-in-ma... See more As a medical translator, I was recently asked about the difference between two terms: “nonclinical study” and “preclinical study”. Unfortunately, I was not able to provide the answer, because I could not find any regulatory documents in which these terms were clearly separated.
As far as I can gather, these terms are very similar (both mainly refer to animal studies with a similar purpose), but the term “preclinical study” refers to a study performed before a first-in-man study, whereas the term “nonclinical study” refers to a study that can be performed both before a clinical study and alongside with it.
Am I right? Or there are other significant differences between them? ▲ Collapse
| | | | | they are the same thing | Jan 21, 2018 |
I don't think there are any technical differences. Pre-clinical studies are so-called from the perspective of regulatory workflow and are needed to commence clinical trials. Whereas nonclinical studies are all those which do not involve human subjects. I can easily imagine them being performed outside the regulatory framework or at any time really.
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On the one hand, I suspect that nonclinical studies are studies carried out without a specific intention for them to be the basis for a clinical study. On the other hand, I would suppose that pre-clinical studies are carried out with a view to their being specifically relevant to a particular clinical study.
Therefore, I think that these terms do probably not mean the same thing.
[Edited at 2018-01-21 12:55 GMT]
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Anne Schulz
Alemania
Local time: 13:51
inglés al alemán
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| For the EMA, they are the same | Jan 21, 2018 |
The European Medicines Agency uses both terms interchangeably in their guidelines on pharmaceutical product informations. Whether or not there is a difference in the US, I don't know.
| | | | | | LEXpert 
Estados Unidos
Local time: 06:51
Miembro 2008
croata al inglés
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| Different language versions of the EMA templates are inconsistent on this point | Jan 21, 2018 |
It's easy to see how the confusion might arise, since the different language versions of the SmPC template seem to be inconsistent. For example, in the exact same passages:
EN template - Sec. 5.3 title refers to "Preclinical safety data" but in the subsequent text it's "non-clinical data".
HR (Croatian) template - Sec. 5.3 refers (in Croatian) to "Non-clinical safety data" in the title and "non-clinical data" in the text
DE template - Sec. 5.3 refers (in German) to "Preclinical... See more It's easy to see how the confusion might arise, since the different language versions of the SmPC template seem to be inconsistent. For example, in the exact same passages:
EN template - Sec. 5.3 title refers to "Preclinical safety data" but in the subsequent text it's "non-clinical data".
HR (Croatian) template - Sec. 5.3 refers (in Croatian) to "Non-clinical safety data" in the title and "non-clinical data" in the text
DE template - Sec. 5.3 refers (in German) to "Preclinical safety data" in the title and to "preclinical data" in the text.
No wonder people are confused. ▲ Collapse
| | | | | Depends at which phase drug is | Aug 9, 2018 |
If the animal studies conducted before IND application then it is call Pre-clinical study. If it is conducted during clinical development of drug, i.e. after IND submission, then it is Non clinical study. This is what i understand!!
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