Microbicide PCT - depends on the period of usage in humans...

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Study: Pharmacological and Safety studies of the Candidate Microbicide Formulation Coordinator: Dr. V. Jagadeesan, Former Deputy Director (Sr. Grade), National Institute of Nutrition, Hyderabad
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Loud Thinking!
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ISSUE I You are developing agents that have an effect on the genome of the virus. So GENOTOXIC STUDIES are necessary. IN VITRO STUDIES Ames Test ( Bact. Mutag. Test ) E. Coli / CHO Test IN VIVO STUDIES Genotoxic Testing Micro lesions ( Point Mutations ) Macro lesions: Chromosomal aberrations (SCE, Micro Nucleus Test)
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ISSUE II PCT STUDY Two species and not three sp. (One rodent / one non rodent) Route of application : same as in humans – intra vaginal LD50 studies required, if it is a new molecule (otherwise historical data) Period of testing (Acute/ sub-acute / chronic)
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Unformatted text preview: depends on the period of usage in humans. Vehicle control to be included) End points :Viral challenge and clearance? Local histopathology like inflammation? Organ pathology? T cell/ lymphokine responses? SA/ Chronic studies : Reversal studies ? ISSUE III PHARMACOKINETIC / PHARMACODYNAMIC STUDIES Half Life (T ½) and protein binding of drugs Metabolites study Methodologies? ( HPLC, GC.MS ) Standards? Characterisation and relative contribution of each metabolite (or the parent compound) to the microbicidal action – Research angle! ISSUE IV P C T Cost Factor to be built in , while outsourcing the activity to a GLP – accredited Lab. Time bound Labour Intensive High cost factor Thank You!!...
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Microbicide PCT - depends on the period of usage in humans...

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