Central Drug Research Institute Tender

List of Services as per TERMS OF REFERENCE (TOR) of PUBLISHED REQUEST FOR PROPOSAL (RFP)

Consultancy services to carry out Dose Response Study in Male Dogs Study: Non-GLP Oral pharmacokinetic studies/parameters of CDRI Compound (S016-1348) following three doses oral administration in Healthy Male (n=3 per dose) Non-Naive Beagle dogs [total dogs: 9; Age/weight: 1– 3 years/ 10 to 12 kg][15 min, 30 min, 45 min, 1 h, 3 h, 6 h, 12 h and 24 h post-oral dose (Total 8 time points/dog)] Note 1: Bioanalytical LC-MS/MS method using dog plasma matrix is available and will be provided by sponsor. Note 2: Prior to the study, all dogs will have haematology, clinical chemistry and urine analysis details, all results will be scrutinized by the study veterinarian and dogs showing parameters within normal limits will be selected for the study. Only healthy animals will be included in the study and complete veterinary examination will be conducted and will be included in the study report. Note 3: Single oral dosing of three different doses. (Doses and required quantity of compound will be provided by sponsor). Note 4: Vendor needs to provide Reports which includes Individual animal data, Plasma Profiles and Pharmacokinetic Parameters (i.e Cmax, Tmax, T1/2, AUC0-t, AUC0-∞, Vd, Cl, MRT, etc) (n=3 of each dose) using suitable software (i.e Phoenix WinNonlin), etc.