Biosimulation derived strategies for Speciality Formulations and Complex Generics
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Smart Strategies enabling seamless integration of formulation characteristics, experimental data, pharmacokinetics and regulatory strategy synergised by mathematical modeling.
Our accumulated experimental expertise and real world experience with Bio-simulations can serve as your technology booster for design and development of various dosage forms including inhalers, NDDS, topical as well solid or liquid oral dosage forms accelerating their development, optimisation, clinical trials, and regulatory strategy across various markets.
- Absorption modeling : Assess GI segmental absorption of drug vis-à-vis physicochemical and formulation properties and explore the benefits strategically.
- Dissolution models and IVIVC correlation
- Our strong expertise in Physiological pharmacokinetic modelling (PBPK) provides a unique Model Informed Development tool to speed up your research.
Biowaivers Virtual trial simulation Virtual BE
- Selection of formulation
- Dosage form changes
- Establishing dissolution safe space.
Design of trials for 505 (b)(2) or novel delivery systemsLife-cycle managementDesign of trials for NDDS and other non oral products
At Pleroo Research, we have provided Biosimulation as well as regulator strategy support for development of various products ranging from oral dosage forms, topical as well as inhalations. We have evolved into an efficient workflow of integrating physicochemical, biopharmaceutical and pharmacological aspects into product development space bringing an integrated approach minimising risks, having grounded on sound rationale.
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