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Ravisekhar Kasibhatta

Ravisekhar Kasibhatta

RavisekharKasibhatta,VicePresident,ClinicalResearchofLupinPharmaceuticals,India.AProfessionalinClinicalResearchhavingin-depthknowledgeofClinical,bioanalytical,Pharmacokinetic&pharmacodynamicsofpharmaceuticaldomain.GoodunderstandingskillstodoIn-vitroBEstudies,IVIVC&Biopharmaceuticsandhaveanalyticalandproblem-solvingskills,focussedapproach,adaptivetothechangingenvironmentandprogressiveattitudewithstrongresultorientation&timelydeliverable.ActiveteamplayerofseniormanagementinstrategizingthebusinessofoutsourcingClinicalTrial/medicalresearchbusinessforGenericproductprograminvarioustherapeuticareas.AfairworkingknowledgeonGenericClinicaltrialforDerma,Ophthalmic,Respiratoryproductsforconductingclinicalendpointstudies.Agoodunderstanding&skillstoconductPK/PDstudiesforBiosimilarprogram.ExpertiseinsettingupCROs,Bioanalytical&ClinicallaboratoriesmeetingtheISOstandards,GCP/GLPcompliance&otherapplicableinternationalquality/regulatorystandards.WellversedwithlatestanalyticalinstrumentslikeLC-MS/MSsystem

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详细介绍

Ravisekhar Kasibhatta, Vice President, Clinical Research of Lupin Pharmaceuticals, India. A Professional in Clinical Research having in-depth knowledge of Clinical, bioanalytical, Pharmacokinetic & pharmacodynamics of pharmaceutical domain. Good understanding skills to do In-vitro BE studies, IVIVC & Biopharmaceutics and have analytical and problem-solving skills, focussed approach, adaptive to the changing environment and progressive attitude with strong result orientation & timely deliverable.Active team player of senior management in strategizing the business of outsourcing Clinical Trial / medical research business for Generic product program in various therapeutic areas. A fair working knowledge on Generic Clinical trial for Derma, Ophthalmic, Respiratory products for conducting clinical endpoint studies. A good understanding & skills to conduct PK / PD studies for Biosimilarprogram.Expertise in setting up CROs, Bioanalytical & Clinical laboratories meeting the ISO standards, GCP/GLP compliance & other applicable international quality / regulatory standards. Well versed with latest analytical instruments like LC-MS/MS systems employed in analysis of BA/BE study samples using SPE, LLE, Derivatization techniques & ELISA Techniques etc.