Gundeti Manoj

Biography

 Bio-pharmaceutics.  Design of Experiments (DOE) -Quality by Design Activities using Design Expert. 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. 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 developmental and evaluation aspects of NDDS and familiar with knowledge of formulation of conventional dosage forms, IV-IVC and Quality by Design (QbD) analysis. PK analyis using (WinNonlin 5.3), Phoenix WinNolin 6.3, Pharmacokinetic Compartmental, Non-Compartmental modelling and Interpretation Protocol; Study-report; Designing of Bioavailability/ Bioequivalence studies as per regulatory requirements. Review of Clinical study protocol and study report Pharmacokinetic Drug interaction studies and metabolic profiling Bio-analytical method development and validation.

Research Interest

 Pharmaceutical science