Question

Your newly established facility was recognised by NATA as being compliant with the OECD Principles of GLP and your first GLP study is now well under way. It is a multi-site study. The in-life aspect of the study is being conducted by a Test Facility located in Switzerland. Rat plasma samples are being shipped to your GLP facility in Brisbane.

However, troubles lie ahead. The person responsible for the analytical phase in your Brisbane facility has just informed you that she has resigned to take up another job elsewhere, effective immediately.

After the initial shock you quickly regain your composure and start compiling a list of what now needs to occur in order for the analytical phase of the study to be successfully completed.

Identify five (5) actions / processes that must occur in order for the study to remain compliant with the Principles of GLP. Each action / process should be described in one sentence.

Answer 1

Following actions/processes must be taken place in order for the study to get complete:

1. Absorption: The route and dose of drug administration would determine the absorption rate and extent by the body. This will help in knowing whether the drug is stable under physiological conditions or it will destabilize and excreted away.
2. Distribution: After a drug is absorbed, its relative distribution in each part/organ of the body must be investigate in real-time manner for at least 24 hours. This would give an idea about tissue-specific, if any, accumulation of the drug.
3. Metabolism: Once the drug is retented in the tissue, it must get metabolized for obtaining its pharmacological effects. The metabolic kinetics must be investigated by using appropriate and suitable techniques.
4. Excretion: After a substantial period of time, the excretion kinetics of the drug must be studied in order to know the kinetics of drug clearance from the body.
5. Toxicity: Since the drug is newly discovered, its potentially toxic effects must be investigated using appropriate host systems, at multiple doses and multiple time periods.