Question

Assessment Task: Assume the role of Study Director and prepare a GLP Study Plan for the following scenario:

A Sponsor (Dr Craig Smith of New Technologies Ltd, 300 Meyo Street, Camptom, NSW, 3402, Australia; [email protected]) has signed a contract for a rat GLP study to be conducted in your facility. The study is to be conducted in accordance to OECD guideline 407.

The efficacious dose of the compound is 100 mg/kg while the solubility of the test item, LAF-001, has limited the highest dose to be assessed to 700mg/kg. The vehicle for the test item is water. The test item appears to be stable in vehicle for 7 days at 2-8°C. The test item, in its powdered form, is 98% pure and is to be stored below -20°C. It has a retest date of October 2017. A toxicokinetic analysis of plasma samples is to be performed on the last day of dosing. The time points for intravenous blood collection are pre-dose, 10, 30, 60 min, 4, 8, 12 & 24h post-dose. Blood samples will be collected into tubes containing Lithium Heparin and are to be centrifuged within 30 minutes of collection. The resulting plasma will be divided into two aliquots (primary & secondary) and will be stored at -80°C prior to shipment.

A bioanalytical method validation for LAF-001 in rat plasma has been undertaken at ADME Pty Ltd, Bioanalysis St, Colorado, 11573, USA and the primary samples are to be transferred there (on dry ice) for analysis. The person responsible for sample analysis is Dr Simon Alve.

Answer 1