Sai Prachetan Balguri obtained his Bachelor’s degree in the Pharmaceutical Sciences from the Kakatiya University, India. He carried out his PhD work in pharmaceutical sciences with emphasis in Pharmaceutics from the University of Mississippi, MS, USA. Currently, he is working as an ORISE research fellow at U.S. FDA in the office of pharmaceutical quality (OPQ). His research encompasses the expertise and experience garnered from academia, industry and agency. Sai worked on several collaborated and individual research projects awarded from National Institutes of Health (NIH) and other agencies. His research expertise is concentrated on the design and development of Novel Drug Delivery Systems for delivering oral, sub-lingual and ocular small molecule therapeutics. Sai’s research has been published in several peer-reviewed journals in the field of pharmaceutical sciences. Currently, he is working on the design and development of patient- centric pediatric oral formulations.

Experience in pre-formulation and formulation conceptualization, but not limited to surface area, morphometrical analysis, physico-chemical stability and crystallinity assessment of API (DSC, pXRD, TGA, FTIR and hot stage microscopy). Determination of parameters such as solubility, pKa and partition coefficient. Lyophilization (freeze/spray drying techniques) of drug product formulations. Rheological characterization of emulsions, suspensions, colloidal systems and gels using Brookfield Viscometer (DV-II Pro). Profound experiential knowledge in designing and executing in-vitro release testing (IVRT), in-vitro permeation testing (IVPT) for topicals and In vitro bio-relevant dissolution testing (IVDT) for solid/liquid oral formulations. In-silico modelling for prediction of in vivo performance of drug products Expertise in method development and validation for analysis of drug molecules using UV spectroscopy, HPLC and LC/MS. Expertise in using Manual/Automatic tablet press, HAKEE minilab extruder, disintegration/dissolution apparatus, extrusion spheronization and pan coating techniques. Insight on oral simulation models, IVIVC Convolution/Deconvolution techniques and PK-PD modelling for drug product development. Knowledge on manufacturing, process optimization/scale-up for development of immediate and controlled release dosage forms. Knowledge on drug application guidelines and filing (NDA, ANDA) complying FDA, CGMP’s regulations. Also familiar with GLP/GMP requirements. Experience in writing technical documents/reports, protocols and patent applications.