We are delighted to announce that Principal Scientist Parmesh Gajjar will be presenting Seda’s novel ideas on model-integrated bioequivalence pathways at the upcoming workshop jointly hosted by the FDA (Food and Drug Administration) and Centre for Research on Complex Generics (CRCG). This free virtual workshop will bring together relevant stakeholders from across the generic and new drug industries, academia, and regulatory bodies to explore how modelling and simulation can aid bioequivalence assessment for long acting injectables.
Demonstrating in-vivo bioequivalence (BE), i.e. showing that a test product delivers the same drug at the same rate as a reference product, is particularly challenging for long acting injectables since these particular products are engineered to release active moieties over one month or longer. As a result, the timescales of such BE studies can be of the order of years, leading to high patient drop outs. The workshop will examine how modelling and simulations can be integrated into novel study designs and data analysis to allow such studies to be more streamlined.
Using the schizophrenia treatment Paliperidone Palmitate as a case study illustration, Parmesh Gajjar will be presenting Seda’s ideas on how Population Pharmacokinetic modelling can be used to assess bioequivalence of such long acting products using an alternative paradigm. Alongside stimulating new ideas, these ideas also offer opportunities for risk reduced product assessment. In a wider sense, the results can be applied to a broad spectrum of complex parenterals where bioequivalence assessment poses large barriers to generic development.
Seda’s team of experts have many years of experience of all forms of pharmacokinetic modelling across large pharma and biotech and across late discovery to product launch. Seda’s focus is on modelling in real time (rather than a retrospective justification) to aid clear, objective, and decisive decision making. Alongside modelling expertise in Population PK analysis, absorption and dissolution modelling and combined PK-PD analysis, the unique combination of biopharmaceutics, clinical pharmacology and experimental dissolution expertise that resides in Seda means we are well placed to support modelling & simulation analyses for biopharmaceutics. Find out more about Seda’s modelling in this white paper by Paul Dickinson.
The free virtual workshop will take place on November 30, 2021. For more information, and to register for this free event, please visit the event website: