Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib

Lipids and Lipid-Based Formulations: Optimizing the Oral Delivery of Lipophilic Drugs

Porter, C. J. H., Trevaskis, N. L., & Charman, W. N. (2007) · Nature Reviews Drug Discovery · doi:10.1038/nrd2197 · Cited by 1,824 · see citing works

Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update

Jantratid, E., Janssen, N., Reppas, C., & Dressman, J. B. (2008) · Pharmaceutical Research · doi:10.1007/s11095-008-9569-4 · Cited by 764 · see citing works

Characterization of the Human Upper Gastrointestinal Contents Under Conditions Simulating Bioavailability/Bioequivalence Studies

Kalantzi, L., Goumas, K., Kalioras, V., Abrahamsson, B., Dressman, J., & Reppas, C. I. (2005) · Pharmaceutical Research · doi:10.1007/s11095-005-8476-1 · Cited by 659 · see citing works

BDDCS Applied to Over 900 Drugs

Benet, L. Z., Broccatelli, F., & Oprea, T. I. (2011) · The AAPS Journal · doi:10.1208/s12248-011-9290-9 · Cited by 636 · see citing works

Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

Jones, H., Chen, Y., Gibson, C., Heimbach, T., Parrott, N., Peters, S., Snoeys, J., Upreti, V., Zheng, M., & Hall, S. (2015) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.37 · Cited by 488 · see citing works

Prediction of Intestinal First-Pass Drug Metabolism

Yang, J., Jamei, M., Yeo, K., Tucker, G., & Rostami-Hodjegan, A. (2007) · Current Drug Metabolism · doi:10.2174/138920007782109733 · Cited by 366 · see citing works

Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds

Vertzoni, M., Dressman, J., BUTLER, J., et al. (2005) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2005.03.002 · Cited by 360 · see citing works

Drug Absorption Interactions Between Oral Targeted Anticancer Agents and PPIs: Is pH-Dependent Solubility the Achilles Heel of Targeted Therapy?

Budha, N. R., Frymoyer, A. R., Smelick, G. S., Jin, J. Y., Yago, M. R., Dresser, M. J., Holden, S. N., Benet, L. Z., & Ware, J. A. (2012) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2012.73 · Cited by 340 · see citing works

Targeting Anaplastic Lymphoma Kinase in Lung Cancer

Shaw, A. T., & Solomon, B. (2011) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-10-1591 · Cited by 309 · see citing works

Estimation of the increase in solubility of drugs as a function of bile salt concentration

Mithani, S. D., Bakatselou, V., TenHoor, C. N., & Dressman, J. B. (1996) · Pharmaceutical Research · doi:10.1023/a:1016062224568 · Cited by 303 · see citing works

Oral Absorption of Poorly Water-Soluble Drugs: Computer Simulation of Fraction Absorbed in Humans from a Miniscale Dissolution Test

Takano, R., Sugano, K., Higashida, A., et al. (2006) · Pharmaceutical Research · doi:10.1007/s11095-006-0162-4 · Cited by 281 · see citing works

Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK

Wagner, C., Zhao, P., Pan, Y., Hsu, V, Grillo, J., Huang, S., & Sinha, V (2015) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.33 · Cited by 276 · see citing works

Estimating drug solubility in the gastrointestinal tract

Dressman, J., Vertzoni, M., Goumas, K., & Reppas, C. I. (2007) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2007.05.009 · Cited by 237 · see citing works

Solubility and Dissolution Profile Assessment in Drug Discovery

Sugano, K., Okazaki, A., Sugimoto, S., Tavornvipas, S., Omura, A., & Mano, T. (2007) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.22.225 · Cited by 212 · see citing works

Accuracy of calculated pH-dependent aqueous drug solubility

Bergström, C. A. S., Luthman, K., & Artursson, P. (2004) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2004.04.006 · Cited by 198 · see citing works

Prevalence of Acid-Reducing Agents (ARA) in Cancer Populations and ARA Drug–Drug Interaction Potential for Molecular Targeted Agents in Clinical Development

Smelick, G. S., Heffron, T. P., Chu, L. K., Dean, B., West, D. A., DuVall, S. L., Lum, B. L., Budha, N. R., Holden, S. N., Benet, L. Z., et al. (2013) · Molecular Pharmaceutics · doi:10.1021/mp400403s · Cited by 191 · see citing works

Microenvironmental pH Modulation in Solid Dosage Forms

Badawy, S. I. F., & Hussain, M. A. (2007) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.20932 · Cited by 191 · see citing works

Anti-inflammatory/Anti-oxidative Stress Activities and Differential Regulation of Nrf2-Mediated Genes by Non-Polar Fractions of Tea Chrysanthemum zawadskii and Licorice Glycyrrhiza uralensis

Wu, T.-Y., Khor, T. O., Saw, C. L. L., Loh, S. C., Chen, A. I., Lim, S. S., Park, J. H. Y., Cai, L., & Kong, A. N. T. (2010) · The AAPS Journal · doi:10.1208/s12248-010-9239-4 · Cited by 177 · see citing works

Predicting Pharmacokinetics of Drugs Using Physiologically Based Modeling—Application to Food Effects

Parrott, N. J., Lukacova, V., Fraczkiewicz, G., & Bolger, M. B. (2009) · The AAPS Journal · doi:10.1208/s12248-008-9079-7 · Cited by 150 · see citing works

Predicting Pharmacokinetic Food Effects Using Biorelevant Solubility Media and Physiologically Based Modelling

Jones, H. M., Parrott, N. J., Ohlenbusch, G., & Lav, T. (2006) · Clinical Pharmacokinetics · doi:10.2165/00003088-200645120-00006 · Cited by 149 · see citing works

Predicting the effect of cytochrome P450 inhibitors on substrate drugs: Analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration

Wagner, C., Pan, Y., Hsu, V., Grillo, J. A., Zhang, L., Reynolds, K. S., Sinha, V., & Zhao, P. (2015) · Clinical Pharmacokinetics · doi:10.1007/s40262-014-0188-4 · Cited by 148 · see citing works

Applications of Physiologically Based Absorption Models in Drug Discovery and Development

Parrott, N. J., & Lavé, T. (2008) · Molecular Pharmaceutics · doi:10.1021/mp8000155 · Cited by 123 · see citing works

Study of pH-dependent solubility of organic bases. Revisit of Henderson-Hasselbalch relationship

Völgyi, G., Baka, E., Box, K. J., et al. (2010) · Analytica Chimica Acta · doi:10.1016/j.aca.2010.05.022 · Cited by 119 · see citing works

Impaired drug absorption due to high stomach pH: a review of strategies for mitigation of such effect to enable pharmaceutical product development

Mitra, A., & Kesisoglou, F. (2013) · Molecular Pharmaceutics · doi:10.1021/mp400256h · Cited by 108 · see citing works

pH-Dependent Drug–Drug Interactions for Weak Base Drugs: Potential Implications for New Drug Development

Zhang, L., Zhang, L., Wu, F., et al. (2014) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2014.87 · Cited by 108 · see citing works

Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status

Li, M., Zhao, P., Pan, Y., & Wagner, C. (2017) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12260 · Cited by 107 · see citing works

Composition and Physicochemical Properties of Fasted‐State Human Duodenal and Jejunal Fluid: A Critical Evaluation of the Available Data

Fuchs, A., & Dressman, J. (2014) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.24183 · Cited by 105 · see citing works

Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated in Vitro in Vivo Extrapolation Perspective Using Ketoconazole as a Model Drug

Pathak, S. M., Ruff, A., Kostewicz, E. S., Patel, N. K., Turner, D. B., & Jamei, M. (2017) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.7b00406 · Cited by 97 · see citing works

Estimation of Intragastric Solubility of Drugs: In What Medium?

Vertzoni, M., Pastelli, E., Psachoulias, D., et al. (2007) · Pharmaceutical Research · doi:10.1007/s11095-006-9209-9 · Cited by 96 · see citing works

The Effects of Oral Doses of Lansoprazole and Omeprazole on Gastric pH

Tolman, K. G., Sanders, S. W., Buchi, K. N., Karol, M. D., Jennings, D. E., & Ringham, G. L. (1997) · Journal of Clinical Gastroenterology · doi:10.1097/00004836-199703000-00003 · Cited by 95 · see citing works

Effects of ranitidine and sucralfate on ketoconazole bioavailability

Piscitelli, S. C., Goss, T. F., Wilton, J. H., et al. (1991) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.35.9.1765 · Cited by 94 · see citing works

Inhibition of Atazanavir Oral Absorption by Lansoprazole Gastric Acid Suppression in Healthy Volunteers

Tomilo, D. L., Smith, P. F., Ogundele, A., DiFrancesco, R., Berenson, C. S., Eberhardt, E., Bednarczyk, E. M., & Morse, G. D. (2006) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1592/phco.26.3.341 · Cited by 89 · see citing works

Systemic Availability and Lymphatic Transport of Human Growth Hormone Administered by Subcutaneous Injection

Charman, S. A., Segrave, A. M., Edwards, G. A., & Porter, C. J. H. (2000) · Journal of Pharmaceutical Sciences · doi:10.1002/(sici)1520-6017(200002)89:2 · Cited by 83 · see citing works

Mechanistic Physiologically Based Pharmacokinetic Modeling of the Dissolution and Food Effect of a Biopharmaceutics Classification System IV Compound—The Venetoclax Story

Riedmaier, A. E., Lindley, D. J., Hall, J. A., Castleberry, S. A., Slade, R. T., Stuart, P., Carr, R. A., Borchardt, T. B., Bow, D. A. J., & Nijsen, M. (2017) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2017.09.027 · Cited by 81 · see citing works

Measurement of Surface pH of Pharmaceutical Solids: A Critical Evaluation of Indicator Dye-Sorption Method and its Comparison With Slurry pH Method

Pudipeddi, M., Zannou, E. A., Vasanthavada, M., et al. (2007) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.21052 · Cited by 80 · see citing works

Dissolution and Solubility Behavior of Fenofibrate in Sodium Lauryl Sulfate Solutions

Granero, G. E., Ramachandran, C., & Amidon, G. L. (2005) · Drug Development and Industrial Pharmacy · doi:10.1080/03639040500272108 · Cited by 80 · see citing works

Application of PBPK modeling to predict human intestinal metabolism of CYP3A substrates – An evaluation and case study using GastroPlus™

Heikkinen, A. T., Baneyx, G., Caruso, A., & Parrott, N. (2012) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2012.06.013 · Cited by 76 · see citing works

Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation

Shepard, T., Scott, G., Cole, S., Nordmark, A., & Bouzom, F. (2015) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.30 · Cited by 75 · see citing works

Absorption, distribution, metabolism and excretion (ADME) of the ALK inhibitor alectinib: results from an absolute bioavailability and mass balance study in healthy subjects

Morcos, P. N., Yu, L. J., Bogman, K., et al. (2016) · Xenobiotica · doi:10.1080/00498254.2016.1179821 · Cited by 68 · see citing works

Predicting the Intestinal Solubility of Poorly Soluble Drugs

Glomme, A., Mrz, J., & Dressman, J. (2007) · Wiley-VCH eBooks · doi:10.1002/9783906390468.ch16 · Cited by 54 · see citing works

Assessment of Bioequivalence of Weak Base Formulations Under Various Dosing Conditions Using Physiologically Based Pharmacokinetic Simulations in Virtual Populations. Case Examples: Ketoconazole and Posaconazole

Cristofoletti, R., Patel, N. K., & Dressman, J. (2016) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2016.10.008 · Cited by 50 · see citing works

Development of a Unified Dissolution and Precipitation Model and Its Use for the Prediction of Oral Drug Absorption

Jakubiak, P., Wagner, B., Grimm, H. P., Petrig-Schaffland, J., Schuler, F., & Alvarez‐Sánchez, R. (2015) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.5b00808 · Cited by 49 · see citing works

Clinical Drug–Drug Interactions Through Cytochrome P450 3A (CYP3A) for the Selective ALK Inhibitor Alectinib

Morcos, P. N., Cleary, Y., Guerini, E., Dall, G., Bogman, K., Petris, L. D., Viteri, S., Bordogna, W., Yu, L. J., Martin‐Facklam, M., et al. (2016) · Clinical Pharmacology in Drug Development · doi:10.1002/cpdd.298 · Cited by 49 · see citing works

The Effects of Omeprazole on Intragastric pH, Intestinal Motility, and Gastric Emptying Rate

Rasmussen, L. (1999) · Scandinavian Journal of Gastroenterology · doi:10.1080/003655299750025868 · Cited by 45 · see citing works

Quantitative prediction of formulation-specific food effects and their population variability from in vitro data with the physiologically-based ADAM model: A case study using the BCS/BDDCS Class II drug nifedipine

Patel, N. K., Polak, S., Jamei, M., Rostami‐Hodjegan, A., & Turner, D. B. (2013) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2013.09.006 · Cited by 44 · see citing works

Physiologically Based Absorption Modelling to Predict the Impact of Drug Properties on Pharmacokinetics of Bitopertin

Parrott, N. J., Hainzl, D., Scheubel, E., et al. (2014) · The AAPS Journal · doi:10.1208/s12248-014-9639-y · Cited by 31 · see citing works

Utility of Physiologically Based Modeling and Preclinical In Vitro/In Vivo Data to Mitigate Positive Food Effect in a BCS Class 2 Compound

Xia, B., Heimbach, T., Lin, T., Li, S., Zhang, H., Sheng, J., & He, H. (2013) · AAPS PharmSciTech · doi:10.1208/s12249-013-0018-2 · Cited by 29 · see citing works

The impact of reduced gastric acid secretion on dissolution of salts of weak bases in the fasted upper gastrointestinal lumen: Data in biorelevant media and in human aspirates

Litou, C., Vertzoni, M., Xu, W., et al. (2017) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2017.02.009 · Cited by 29 · see citing works

Lymphocyte Transformation and Delayed Hypersensitivity in Crohn's Disease

Röpke, C. (1972) · Scandinavian Journal of Gastroenterology · doi:10.3109/00365527209180975 · Cited by 28 · see citing works

Time effects of food intake on the pharmacokinetics and pharmacodynamics of quazepam

Yasui‐Furukori, N., Takahata, T., Kondo, T., Mihara, K., Kaneko, S., & Tateishi, T. (2003) · British Journal of Clinical Pharmacology · doi:10.1046/j.1365-2125.2003.01775.x · Cited by 16 · see citing works

Antitumor activity of alectinib (CH5424802/RO5424802) for ALK-rearranged NSCLC with or without prior crizotinib treatment in bioequivalence study.

Nakagawa, K., Hida, T., Seto, T., et al. (2014) · Journal of Clinical Oncology · doi:10.1200/jco.2014.32.15_suppl.8103 · Cited by 12 · see citing works

Physiologically Based Pharmacokinetic Modelling for First-In-Human Predictions: An Updated Model Building Strategy Illustrated with Challenging Industry Case Studies

Miller, N. A., Reddy, M. B., Heikkinen, A. T., Lukacova, V., & Parrott, N. (2019) · Clinical Pharmacokinetics · doi:10.1007/s40262-019-00741-9 · Cited by 142 · see citing works

Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective

Lin, W., Chen, Y., Unadkat, J. D., Zhang, X., Wu, D., & Heimbach, T. (2022) · Pharmaceutical Research · doi:10.1007/s11095-022-03274-2 · Cited by 137 · see citing works

Drug-Drug Interactions With a Pharmacokinetic Basis

Cheng, L., Chang, T., & Wong, H. (2021) · Reference Module in Biomedical Sciences · doi:10.1016/b978-0-12-820472-6.00179-1 · Cited by 3 · see citing works

The influence of serum lipoproteins on the pharmacokinetics and pharmacodynamics of lipophilic drugs and drug carriers.

Wasan, K. M., & Lopez‐Berestein, G. (1993) · PubMed · Cited by 23 · see citing works

A physiologically based pharmacokinetic model linking plasma protein binding interactions with drug disposition

Buur, J. L., Baynes, R. E., Smith, G., et al. (2008) · Research in Veterinary Science · doi:10.1016/j.rvsc.2008.07.003 · Cited by 28 · see citing works

Pharmacokinetics of flurbiprofen

Kaiser, D. G., Brooks, C. D., & Lomen, P. L. (1986) · The American Journal of Medicine · doi:10.1016/0002-9343(86)90104-x · Cited by 32 · see citing works

Pharmacokinetic and pharmacodynamic aspects of site-specific drug delivery

Boddy, A. V., & Aarons, L. J. (1989) · Advanced Drug Delivery Reviews · doi:10.1016/0169-409x(89)90008-2 · Cited by 11 · see citing works