Common Market for Eastern and Southern Africa, COMESA,African Union
22-08-2025
Work Detail
Request for proposals for Pharmacokinetics Study Services: Sprague Dawley Rats II. Scope of Work The scope of work includes the execution of the PK study in female Sprague-Dawley rats as outlined below. The goals of the study are to (1) characterize a control microsphere (MS) formulation in multiple vehicles (aqueous and non-aqueous) to assess the impact of the vehicle composition on PK performance and (2) characterize optimized MS formulations in the aqueous vehicle to assess the impact of formulation/process parameters on PK performance. Data will be used to inform optimization of both the MS and vehicle formulations. Non-aqueous formulations will be supplied in the vehicle (oil + surfactant) and will require resuspension prior to injection. Others MS formulations will be supplied as a dry powder and will need to be resuspended in an aqueous vehicle prior to injection. FHI 360 will provide protocols for resuspension and reconstitution 1 MS formulations suspended in candidate nonaqueous vehicles Control MS in nonaqueous vehicle # 1 5 Female 10 mg per rat Single, subcutaneous injection 2 Control MS in nonaqueous vehicle # 2 3 Control MS in nonaqueous vehicle # 3 4 Control MS in nonaqueous vehicle # 4 5 Candidate MS formulations in aqueous vehicle Control MS in aqueous vehicle 6 Optimized MS #1 in aqueous vehicle 7 Optimized MS #2 in aqueous vehicle 8 Optimized MS #3 in aqueous vehicle Date of Issue of Rfp: Wednesday, August 6, 2025 Date Questions from Supplier Due: Friday, August 15, 2025 Date Answers Due from Fhi 360: Tuesday, August 19, 2025 Date Proposal Due: Friday, August 22, 2025, by 5pm Edt Anticipated Total Period of Performance: 8-11 Months (30 Weeks of In-Life) Approximate Timeframe Vendor Agreement Issued to Successful Candidate(S): September 2025 Tender Link : http://solicitations.fhi360.org/Solicitation.aspx
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