Mechanistic Deconvolution of Oral Absorption Model with Dynamic Gastrointestinal Fluid to Predict Regional Rate and Extent of GI Drug Dissolution

Author:

Yu Alex,Koenigsknecht Mark J.,Hens Bart,Baker Jason R.,Wen Bo,Jackson Trachette L.,Pai Manjunath P.,Hasler William,Amidon Gordon L.,Sun Duxin

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference29 articles.

1. Hens B, Sinko PD, Job N, Dean M, Al-Gousous J, Salehi N, et al. Formulation predictive dissolution (fPD) testing to advance oral drug product development: an introduction to the US FDA funded ‘21st century BA/BE’ project. Int J Pharm. 2018;548(1):120–7.

2. EMEA. Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action. 2019. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-dissolution-specification-generic-solid-oral-immediate-release-products-systemic_en.pdf. Accessed 4 September 2019

3. FDA. Guidance document: dissolution testing of immediate release solid oral dosage forms. 2019. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dissolution-testing-immediate-release-solid-oral-dosage-forms. Accessed 4 September 2019

4. Loo JC, Riegelman S. New method for calculating the intrinsic absorption rate of drugs. J Pharm Sci. 1968;57(6):918–28.

5. Wagner JG, Nelson E. Kinetic analysis of blood levels and urinary excretion in the absorptive phase after single doses of drug. J Pharm Sci. 1964;53:1392–403.

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