Preclinical Research Services - PowerPoint PPT Presentation
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Preclinical Research Services
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Any preclinical study is conducted with a sole objective of ensuring the safety and efficacy of a new drug or medical device before proceeding with their clinical trials on human beings. – PowerPoint PPT presentation
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Title: Preclinical Research Services
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A Step-by-step Guide For Conducting A
Preclinical Study
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First Understand
What is a preclinical study or trial?
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Preclinical trial is testing of a new drug or
medical device on animal subjects in the
laboratory
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Why is it done?
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To know the effects of the new drug and whether
it is safe to be tested on human beings
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How to conduct a preclinical study?
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Step 1 Identify a drug target
- A drug target is any organ, cells, tissues or
specific points in a biological pathway that are
intended to be changed by the drug under
experiment. - E.g. drugs that replace dopamine released by
the dead brain cells in Parkinsons disease. Here
brain cells releasing dopamine are the drug
target.
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Step 2 Develop a Bioassay
- A bioassay is a live system developed to
measure the effects of the drug like a culture of
cells, organs or a whole animal.
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Step 3 Screen the drug in bioassay
Look for the active compounds of the drug in
the bioassay, determine their concentration and
effects on the subject of experiment.
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Step 4 Establish the safe and toxic doses of the
drug
- Determine the safe dose and toxic dose for
drug administration. - Toxic dose is the amount of the drug at which
it becomes harmful instead of proving beneficial.
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Step 5 File for approval as Investigational New
Drug (IND)
- Submit an application for approval by FDA
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What does IND contain?
- How the drug is manufactured?
- Information on drug appearance
- How the drug is formulated? (as pills, liquid
etc.) - How the drug will be analyzed for purity,
concentration, and stability? - How the drug will be tested for its safety?
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Despite the steps, how many drugs get so far in
the process?
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Not more than 3-5
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Reason Increased cost and time taken in
preclinical studies
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What to do?
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Utilize preclinical research services that
integrate all the steps to provide
cost-effective and timely studies.
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To Know more
- Email ID project_at_cognibrain.com
- Phone 91-99400 84145
- Visit us https//www.cognibrain.com/
- Connect with us
