Author Topic: difference between pre-clinical and non-clinical....  (Read 6278 times)

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Offline smithajose7

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Hi all,
    can anybody explain the difference between pre-clinical and non-clinical studies???? ::)

regards,
 Smitha.

Offline Shankar

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Hi Smitha,

Pre-clinical studies are animal studies (Before conduction of clinical studies).

Nonclinical study are may be dissolution studies or clinical studies (Human Trials).

If I am wrong correct me.

Regards,

Shankaranarayanan J
Shankaranarayanan J

Offline smithajose7

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HI,
    Preclinical studies are conducted in animals DG:>. That I know.

But what are non clinical studies? I don't think they are studies conducted in humans ";';';;'. In that case it should be part of clinical studies and we cant call them as non clinical.

waiting for more responses.... H:>

regards,
Smitha


Offline mukul

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Hello,

Pre clinical studies and non clinical studies both are same used as synonym to each other.
These studies are performed before clinical studies (Performed in human).
Theses studies are performed using animal or In vitro (In vitro dissolution, or cell lines e.g. caco 2 model {exactly simulating environment present in Hunan body.}).

Mukul

 DG:>
Mukul

Offline Kumar_Kar

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Hello Everyone,

Both PreClinical and Non Clinical studies are one and the same. When ever we use the word clinical it pertains to humans.

Regards

Kumar

Offline Shankar

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Hi Everyone,

Please anybody provide the link for this definition it will helpful to everyone.

Regards,

Shankaranarayanan J

Offline drpramesharora

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hello, all
           Nonclinical or Pre-Clinical studies are research studies that are conducted, typically on animals, before a permit for a clinical trial on humans can be obtained. Pre-clinical studies serve a vital role in the drug discovery and development processes. These studies can be used to identify lead compounds likely to possess favorable biopharmaceutic and pharmacokinetic properties in humans. In addition, they can facilitate transition of discovery to development, as well as decrease the need for expensive and time-consuming clinical studies



Dr pramesh W:>
["What the mind can conceive and believe,
it can achieve."]

If you believe you can, you probably can. If you believe you won't, you most assuredly won't. Belief is the ignition switch that gets you off the launching pad.-:)

Offline G.Vijayalakshmi

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Nonclinical studies are biomedical studies that are not conducted in human(according to ICH)
ya...........preclinical and non clinical are same.
Nonclinical or Pre-Clinical studies are research studies that are conducted, typically on animals, before a permit for a clinical trial on humans can be obtained. Pre-clinical studies serve a vital role in the drug discovery and development processes. These studies can be used to identify lead compounds likely to possess favorable biopharmaceutic and pharmacokinetic properties in humans. In addition, they can facilitate transition of discovery to development, as well as decrease the need for expensive and time-consuming clinical studies.

Pre-clinical/nonclinical studies include a wide range of studies in a variety of systems to characterize biopharmaceutic and pharmacokinetic properties. Systems used include: in vivo animal models, isolated perfused liver, kidney, intestine, hind limb and heart, Caco-2 cell monolayer absorption model, animal and human liver microsomes. Studies include: bioavailability studies, pharmacokinetic studies, prediction of oral absorption in humans, determination of mechanisms of intestinal absorption, assessment of transport, distribution and elimination of compounds, validated models for cytochrome P450 enzymes, metabolism studies in human liver microsomes, assessment of potential for metabolic drug - drug interactions, analysis of drugs and metabolites in biological matrices, synthetic chemistry, in silico modeling.
“Great dreams of great dreamers are always transcended.”

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