Adithya Karthik Bhattiprolu's scientific contributions

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Publications (4)

Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions
Article
  • Jul 2023
Quality risk assessment following ICH Q9 principles is an important activity to ensure optimal clinical efficacy and safety of a drug product. Typically, risk assessment is focused on product performance wherein critical material attributes, formulation variables, and process parameters are evaluated from a manufacturing perspective. Extending ICH...
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Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective
Article
  • Feb 2023
Dissolution is considered as a critical input into physiologically based biopharmaceutics models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by academia, industry, and regulatory, wider practices are followed for dissolution data input into PBBM models. Due to variety of options available for dissolution data input in...
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Utility of Physiologically Based Biopharmaeutics Modeling (PBBM) in Regulatory Approval: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space
Article
  • Sep 2022
Product DRL is a generic IR tablet formulation with BCS Class-III API, available in two strengths: 50mg & 100mg. The reference and test formulations have salt-A & salt-B of API but both products were bioequivalent based on the in vivo bioequivalence study conducted for higher strength 100mg. While leveraging the generic product to different market,...
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In vitro and In silico Biopharmaceutic Regulatory Guidelines for Generic Bioequivalence for Oral Products; Comparison among various regulatory agencies
Article
  • May 2021
Generic drug development is a complex process that involves development of formulation similar to Reference Listed Drug (RLD). Because of the complexity associated with generic drug development, many regulatory agencies have come up with various guidelines. Out of many guidelines, the Biopharmaceutics classification system (BCS) that was introduced...
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Citations

... Modelling can also be used to address experimental limitations. Bhattiprolu et al. recently reported development of a physiologically based biopharmaceutics model (PBBM) to predict systemic exposure of Class III drugs using in vitro dissolution release profiles [38]. Currently, Class III drugs are eligible for biowaivers if the in vitro dissolution rate is high enough to overcome poor permeability [12]. ...
Reference: A Perspective on Model-Informed IVIVC for Development of Subcutaneous Injectables
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