Project Description

Preclinical Contract Research Organization needed for preclinical toxicology study of Interferon drug:
Toxicology Study: The study is required on 35 male Syrian golden hamsters using our interferon. This study is for 28-days toxicology study followed by a 7-days observation period. The main goal is to show the safety of our interferon alpha 2a with the reference product is essentially the same. The detailed protocol would be provided, Briefly it requires:
-Blood will be collected after 35 days for standard hematology and clinical chemistry.
-Animals will be observed for 35 days for signs of ill health,tier duration,and time of death.
-Pathology:At the end of study, surviving animals will be sacrificed and weighed. A gross necropsy will be performed on all animals in the study. If a necropsy cannot be preformed immediately after death, the animal will be refrigerated at temperatures low enough to minimize autolysis. Necropsies will be preformed within a window period of one to two days. Organ weights will be recorded immediately after necropsy.Liver, lung and kidney samples will be taken in 10% formalin for histopathology
-Laboratory analysis:Microscopic pathology,blood chemistry and hematology will be performed. Kinetic Study in Rat The study will compare the kinetics of Interferons (bio similar products) given sub-cutaneously using Wistar rat.The detailed protocols will be provided but briefly the requirements are:
-There will be 64 male wistar rats having two groups of 32.
-Eight animals, 4 in each group, will be anesthetized bled and terminated at each data point (pre -dose, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h and 144
-A post mortem will be done on all animals to confirm their health status.
-Blood in EDTA for plasma will be collected at pre -dose, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h and 144 h.