We are happy to announce that Senior Modeller, Jake Dickinson, shall be presenting his work on in vitro in vivo correlation (IVIVC) at the upcoming American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 conference. Jake will present a poster titled ‘Development of a methodology to enable non-linear in vitro-in vivo correlation for complex long-acting injections’. A pdf version of the poster can be accessed here.
In this work, authors Jake Dickinson, Claire Patterson, Parmesh Gajjar and Paul Dickinson report the methodology required to establish non-linear IVIVC for complex long acting injectables (LAIs) such as PLGA microspheres for subcutaneous or intramuscular injection. Establishment of linear IVIVC for oral/non-oral dosage forms has been well documented, however, for LAIs with complex release profiles, or for example when dissolution data is generated under accelerated conditions, it is likely a non-linear relationship is required. In this work, we have demonstrated a step-by-step approach for non-linear IVIVC using higher order polynomials, giving a valid IVIVC which could not be achieved using a linear approach. We believe that this is an important first step in establishing IVIVC for complex dosage forms, which can ultimately save time and money and reduce the requirement for in vivo studies.
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 launch. Seda’s focus is on modelling in real time (rather than a retrospective justification) to aid clear, objective, and decisive decision making. Our PK-PD modellers are particularly experienced in the Oncology Therapeutic area. The unique combination of biopharmaceutics, clinical pharmacology and dissolution expertise that resides in Seda alongside our modellers means we are well placed to support PBPK analyses for biopharmaceutics. Find out more about Seda’s pk modelling services and read an introductory guide to PBPK modelling and its applications in this white paper by Paul Dickinson.
Check out our other publications from authors at Seda.
AAPS 2021 PharmSci 360 will be held on October 17-20, 2021 in Philadelphia, Pennsylvania, USA as a hybrid meeting, i.e. a combination of online and in-person programming. Please see the AAPS event website for further details.