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gundetimanoj

GUNDETI MANOJ

Personal Information
Organization / Workplace
Jagtial Area, India India
Occupation
QbD Designee in Research and Development at Aizant Drug Research Solutions Pvt Ltd
Industry
Medical / Health Care / Pharmaceuticals
About
Bio-pharmaceutics. Design of Experiments (DOE) -Quality by Design Activities using Design Expert software. Formulation Risk assessment and Risk analysis.(QRM) Formulation development( Tablets, Capsules and liquid orals) (ANDA ) and optimization of different processes (Wet granulation, Dry granulation, Direct compression, Fluid bed processing (FBP) and Extrusion-Spheronization etc. Assisting for sample size justification, calculation and randomization schedule for all statistical designs. Performing statistical analysis using WinNolin. Involved in planning and design of the study. BA/BE Studies, Queries related to Sampling time points in BE studies, Dissolution, IV-IVC. Good knowledge on...
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