February 24, 2021

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The project is seeking characterization of Colonic Absorption that can facilitate implementation of Extended Release (ER) at early phase of product development and thereby impact overall timeline of development.   The following project steps/milestones have been provided by ETC to aid the respondent in preparing their response; however, respondents are welcome to propose an alternative project plan to meet the project objectives.  

• Establishment of correlation between Caco-2 apparent permeability (Papp) data and human colonic effective permeability (Peff), using an existing data set for the Peff data (see DOI: 10.1021/mp500834v) and generating necessary Caco-2 data

• Methods to consistently apply Caco-2 Papp data to make for more reliable predictions of colonic human Papp, and improvement of in-silico colonic absorption models to enable Extended Release formulations.  

• Investigate the pig as an intermediate species that can be used to confirm the predictions, and further expand options for predictive assessments when molecule properties (e.g. low solubility) make the Caco-2 data generation difficult.

 

Download the Request for Information and submit your response.

 

RFI ISSUED February 24, 2021

QUESTIONS on RFI DUE March 15, 2021

RFI RESPONSES DUE April 15, 2021

Q&A Received