Non-GLP Toxicology Study

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How to Design the best Non-GLP Toxicology Study?
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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.

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• 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
  poorly.
• 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.

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Here we provide you with some quick tips to
design the best and effective Non-GLP toxicology
study
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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.

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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.

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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.

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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.

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• 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.

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If you follow these tips with perseverance, you
can make out the most of your non-GLP toxicology
study.
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Contact Us

• Email ID project_at_cognibrain.com
• Phone [phone]
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