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 [phone]
• Visit us https//www.cognibrain.com/
• Connect with us