Non-GLP Toxicology Study - PowerPoint PPT Presentation

View by Category
About This Presentation

Non-GLP Toxicology Study


How to Design the best Non-GLP Toxicology Study? – PowerPoint PPT presentation

Number of Views:18
Slides: 12
Provided by: cognibrain1


Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: Non-GLP Toxicology Study

How to Design the best Non-GLP Toxicology Study?
Toxicology Studies
  • Good Laboratory Practice (GLP) is a set of
    standards for conducting toxicology studies. They
    define how these studies must be planned,
    performed, monitored, recorded, reported, and
    stored for future reference.
  • However, not all toxicology studies require compli
    ance with the GLP standards. Basic screening
    tests where the safety of the product is not
    assessed do not require GLP compliance.

  • Non-GLP never indicates complete ignorance of the
    GLP standards, its only that few standards may
    not apply to these studies.
  • Nevertheless, non- compliance with the GLP
    standards doesnt mean you design your study
  • Even Non-GLP studies should be carried out in a
    way that reflects the clinical settings, ensures
    the accuracy of the results and maximise your
    return on investment.

Here we provide you with some quick tips to
design the best and effective Non-GLP toxicology
1) Make sure you use an appropriate species
  • Generally, you need two animal species to test
    the safety profile of a drug and one species for
    biologic. Make sure you fulfill this basic
    requirement in your study.
  • Further, preliminary studies to identify and
    confirm that the pharmacological activity is the
    same as in humans should be completed
    before animal testing.

2) Choose the right dose or doses of your drug
  • The science of toxicology is based on the simple
    principle, a relationship between the animal
    response and the amount of drug dose received.
  • Toxicology studies are designed to investigate
    how animals react to the doses from low to high
    levels. The animals are examined at specific
    intervals for the presence or absence of drug
    effects such as clinical signs, changes in
    behavior, alterations in serum chemistries, or
    effects on organs and organ systems.
  • However, to ensure you observe these effects in
    your toxicology studies, choose the recommended
    doses of drugs.

3) For NOAEL, choose a dose with similar exposure
  • NOAEL means No observable adverse effect
    level and is used to define the starting dose of
    the drug in clinical trials.
  • If you wish to define NOAEL with your study,
    choose a dose that result in a similar exposure
    as the estimated clinically relevant dose.
  • Doses higher than this will produce toxicity.

4) Make your study Informative
  • What is the main purpose of a toxicology study?
  • Of course, to define a safe clinical dose. But,
    if you think Non-GLP studies cant accomplish
    this, you are mistaken.
  • Non-GLP toxicology studies are preliminary but
    can be extremely informative. If designed
    appropriately, their results can explain the
    mechanism behind the suspected toxic effect.
  • Also, they can tell the right dosing and whether
    there is an acceptable safety margin to send the
    drug for further trials.

  • Non-GLP toxicology studies should mimic the
    clinical setting as far as possible as the length
    of dosing, route of administration, the frequency
    of dosing, etc.
  • You must also include the ways to monitor safety
    pharmacology measure blood pressure, scan the
    liver and monitor any hyperglycaemic /
    hypoglycaemic events.

If you follow these tips with perseverance, you
can make out the most of your non-GLP toxicology
Contact Us
  • Email ID
  • Phone 044-49595223
  • Visit us https//