Sahoo D, Bandaru R, Samal SK, Naik R, Kumar P, Kesharwani P, et al. Oral drug delivery of nanomedicine. In: Kesharwani P, Taurin S, Greish K, editors. Theory and applications of nonparenteral nanomedicines: Academic Press; 2021. p. 181–207.
Fleisher D, Li C, Zhou Y, Pao LH, Karim A. Drug, meal and formulation interactions influencing drug absorption after oral administration. Clin Implications Clin Pharmacokinet. 1999;36(3):233–54.
Griffin BT, Kuentz M, Vertzoni M, Kostewicz ES, Fei Y, Faisal W, et al. Comparison of in vitro tests at various levels of complexity for the prediction of in vivo performance of lipid-based formulations: case studies with fenofibrate. Eur J Pharm Biopharm. 2014;86(3):427–37.
O’Dwyer PJ, Litou C, Box KJ, Dressman JB, Kostewicz ES, Kuentz M, et al. In vitro methods to assess drug precipitation in the fasted small intestine – a PEARRL review. J Pharm Pharmacol. 2019;71(4):536–56.
Butler J, Hens B, Vertzoni M, Brouwers J, Berben P, Dressman J, et al. In vitro models for the prediction of in vivo performance of oral dosage forms: recent progress from partnership through the IMI OrBiTo collaboration. Eur J Pharm Biopharm. 2019;136:70–83.
Food and Drug Administration. Guidance for industry: the use of physiologically based pharmacokinetic analyses - biopharmaceutics applications for oral drug product development, manufacturing changes, and controls. 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-physiologically-based-pharmacokinetic-analyses-biopharmaceutics-applications-oral-drug-product. Accessed 30 Jun 2022.
Zhang T, Wells E. A review of current methods for food effect prediction during drug development. Curr Pharmacol Rep. 2020;6(5):267–79.
Thakral NK, Meister E, Jankovsky C, Li L, Schwabe R, Luo L, et al. Prediction of in vivo supersaturation and precipitation of poorly water-soluble drugs: achievements and aspirations. Int J Pharm. 2021;600:120505.
Dressman J. Evolution of dissolution media over the last twenty years. Dissolution Technol. 2014;21(3):6–10.
Mudie DM, Samiei N, Marshall DJ, Amidon GE, Bergström CAS. Selection of in vivo predictive dissolution media using drug substance and physiological properties. AAPS J. 2020;22(2):1–13.
Schilderink R, Protopappa M, Fleth-James J, Vertzoni M, Schaefer K, Havenaar R, et al. On the usefulness of compendial setups and tiny-TIM system in evaluating the in vivo performance of oral drug products with various release profiles in the fasted state: case example sodium salt of A6197. Eur J Pharm Biopharm. 2020;149:154–62.
Verwei M, Minekus M, Zeijdner E, Schilderink R, Havenaar R. Evaluation of two dynamic in vitro models simulating fasted and fed state conditions in the upper gastrointestinal tract (TIM-1 and tiny-TIM) for investigating the bioaccessibility of pharmaceutical compounds from oral dosage forms. Int J Pharm. 2016;498(1–2):178–86.
Van Den Abeele J, Schilderink R, Schneider F, Mols R, Minekus M, Weitschies W, et al. Gastrointestinal and systemic disposition of diclofenac under fasted and fed state conditions supporting the evaluation of in vitro predictive tools. Mol Pharm. 2017;14(12):4220–32.
Liu J, Nagapudi K, Dolton MJ, Chiang PC. Utilizing tiny-TIM to assess the effect of acid-reducing agents on the absorption of orally administered drugs. J Pharm Sci. 2021;110(8):3020–6.
International Conference on Harmonisation of technical requiremnets for registration of pharmaceuticals for human use. Pharmaceutical Development Q8(R2). 2009. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf. Accessed 30 Jun 2022.
European Medicines Agency. Guidelines on the pharmacokinetic and clinical evaluation of modified release dosage forms. EMA/CHMP/EWP/280/96 Rev1. Committee for Medicinal Products for Human Use. 2014. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf. Accessed 30 Jun 2022.
Food and Drug Administration. Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. 1997. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/extended-release-oral-dosage-forms-development-evaluation-and-application-vitroin-in-vivo-correlations. Accessed 30 Jun 2022.
Food and Drug Administration. Guidance for industry: SUPAC-SS: nonsterile semisolid dosage forms; scale-up and post-approval changes: chemistry, manufacturing and controls; in vitro release testing and in vivo bioequivalence documentation. 1997. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-ss-nonsterile-semisolid-dosage-forms-scale-and-post-approval-changes-chemistry-manufacturing. Accessed 30 Jun 2022.
Nguyen MA, Flanagan T, Brewster M, Kesisoglou F, Beato S, Biewenga J, et al. A survey on IVIVC/IVIVR development in the pharmaceutical industry–past experience and current perspectives. Eur J Pharm Sci. 2017;102:1–3.
Gonzalez MA, Gray VA. CRS workshop report: using an in vitro–in vivo correlation (IVIVC) to meet challenges in global delivery. Dissolution Technol. 2013;20(4):42–4.
BI. Boehringer Ingelheim clinical trial report. 2018.
Souliman S, Blanquet S, Beyssac E, Cardot JM. A level a in vitro/in vivo correlation in fasted and fed states using different methods: applied to solid immediate release oral dosage form. Eur J Pharm Sci. 2006;27(1):72–9.
Neervannan S. Preclinical formulations for discovery and toxicology: physicochemical challenges. Expert Opin Drug Metab Toxicol. 2006;2(5):715–31.