Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation

[1] Mudie DM(2010)Physiological parameters for oral delivery and in vitro testing Mol Pharm 7 1388-1405

[2] Amidon GL(1988)Measurement of gastrointestinal pH profiles in normal ambulant human subjects Gut 29 1035-1041

[3] Amidon GE(2008)Gut instincts: explorations in intestinal physiology and drug delivery Int J Pharm 364 213-226

[4] Evans DF(2009)Toward an increased understanding of the barriers to colonic drug absorption in humans: implications for early controlled release candidate assessment Mol Pharm 6 60-73

[5] Pye G(2021)Current challenges and future perspectives in oral absorption research: An opinion of the UNGAP network Adv Drug Deliv Rev 171 289-331

[6] Bramley R(2013)Provisional classification and in silico study of biopharmaceutical system based on caco-2 cell permeability and dose number Mol Pharm 10 2445-2461

[7] Clark AG(2016)Novel high/low solubility classification methods for new molecular entities Int J Pharm 511 111-126

[8] Dyson TJ(2015)Development of modified-release tablets of zolpidem tartrate by biphasic quick/slow delivery system AAPS PharmSciTech 16 579-588

[9] Hardcastle JD(2017)Clinical Evaluation of Modified Release and Immediate Release Tacrolimus Formulations AAPS J 19 1332-1347

[10] McConnell EL(2013)Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults Clin Ther 35 333-341

[1] Mudie DM(2010)Physiological parameters for oral delivery and in vitro testing Mol Pharm 7 1388-1405

[2] Amidon GL(1988)Measurement of gastrointestinal pH profiles in normal ambulant human subjects Gut 29 1035-1041

[3] Amidon GE(2008)Gut instincts: explorations in intestinal physiology and drug delivery Int J Pharm 364 213-226

[4] Evans DF(2009)Toward an increased understanding of the barriers to colonic drug absorption in humans: implications for early controlled release candidate assessment Mol Pharm 6 60-73

[5] Pye G(2021)Current challenges and future perspectives in oral absorption research: An opinion of the UNGAP network Adv Drug Deliv Rev 171 289-331

[6] Bramley R(2013)Provisional classification and in silico study of biopharmaceutical system based on caco-2 cell permeability and dose number Mol Pharm 10 2445-2461

[7] Clark AG(2016)Novel high/low solubility classification methods for new molecular entities Int J Pharm 511 111-126

[8] Dyson TJ(2015)Development of modified-release tablets of zolpidem tartrate by biphasic quick/slow delivery system AAPS PharmSciTech 16 579-588

[9] Hardcastle JD(2017)Clinical Evaluation of Modified Release and Immediate Release Tacrolimus Formulations AAPS J 19 1332-1347

[10] McConnell EL(2013)Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults Clin Ther 35 333-341