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Tycho H. Heimbach, Ph.D. - Publications

Affiliations: 
2003 University of Michigan, Ann Arbor, Ann Arbor, MI 
Area:
Pharmacy, Pharmaceutical Chemistry
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37 high-probability publications. We are testing a new system for linking publications to authors. You can help! If you notice any inaccuracies, please sign in and mark papers as correct or incorrect matches. If you identify any major omissions or other inaccuracies in the publication list, please let us know.

Year Citation  Score
2024 Mackie C, Arora S, Seo P, Moody R, Rege B, Pepin X, Heimbach T, Tannergren C, Mitra A, Suarez-Sharp S, Borges LN, Kijima S, Kotzagiorgis E, Malamatari M, Veerasingham S, et al. Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. Molecular Pharmaceutics. 21: 2065-2080. PMID 38600804 DOI: 10.1021/acs.molpharmaceut.4c00202  0.302
2024 Wu F, Mousa Y, Jereb R, Batchelor H, Chakraborty S, Heimbach T, Stier E, Kesisoglou F, Kollipara S, Zhang L, Zhao L. Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products. The Aaps Journal. 26: 19. PMID 38267737 DOI: 10.1208/s12248-024-00886-x  0.353
2023 Tsakalozou E, Mohamed MF, Polak S, Heimbach T. Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary. The Aaps Journal. 25: 96. PMID 37783902 DOI: 10.1208/s12248-023-00862-x  0.396
2023 Bauer A, Berben P, Chakravarthi SS, Chattorraj S, Garg A, Gourdon B, Heimbach T, Huang Y, Morrison C, Mundhra D, Palaparthy R, Saha P, Siemons M, Shaik NA, Shi Y, et al. Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium "Long-Acting Injectables" Working Group. Pharmaceutical Research. PMID 36811809 DOI: 10.1007/s11095-022-03391-y  0.322
2022 Wu F, Mousa Y, Raines K, Bode C, Tsang YC, Cristofoletti R, Zhang H, Heimbach T, Fang L, Kesisoglou F, Mitra A, Polli J, Kim MJ, Fan J, Zolnik BS, et al. Regulatory Utility of Physiologically Based Pharmacokinetic Modeling to Support Alternative Bioequivalence Approaches and Risk Assessment: A Workshop Summary Report. Cpt: Pharmacometrics & Systems Pharmacology. PMID 36530026 DOI: 10.1002/psp4.12907  0.333
2022 Wu D, Sanghavi M, Kollipara S, Ahmed T, Saini AK, Heimbach T. Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs. Pharmaceutical Research. PMID 35840856 DOI: 10.1007/s11095-022-03319-6  0.379
2022 Lin W, Chen Y, Unadkat JD, Zhang X, Wu D, Heimbach T. Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective. Pharmaceutical Research. PMID 35552967 DOI: 10.1007/s11095-022-03274-2  0.449
2022 Aburub A, Chen Y, Chung J, Gao P, Good D, Hansmann S, Hawley M, Heimbach T, Hingle M, Kesisoglou F, Li R, Rose J, Tisaert C. An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow. The Aaps Journal. 24: 49. PMID 35348922 DOI: 10.1208/s12248-022-00699-w  0.313
2022 Laisney M, Heimbach T, Mueller-Zsigmondy M, Blumenstein L, Costa R, Ji Y. Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption. Journal of Pharmaceutical Sciences. 111: 274-284. PMID 34678270 DOI: 10.1016/j.xphs.2021.10.017  0.326
2021 Heimbach T, Kesisoglou F, Novakovic J, Tistaert C, Mueller-Zsigmondy M, Kollipara S, Ahmed T, Mitra A, Suarez-Sharp S. Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms Using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies. Journal of Pharmaceutical Sciences. PMID 34551349 DOI: 10.1016/j.xphs.2021.09.017  0.331
2020 Jogiraju VK, Heimbach T, Toderika Y, Taft DR. Physiologically based pharmacokinetic modeling of altered tizanidine systemic exposure by CYP1A2 modulation: Impact of drug-drug interactions and cigarette consumption. Drug Metabolism and Pharmacokinetics. 37: 100375. PMID 33561738 DOI: 10.1016/j.dmpk.2020.100375  0.361
2020 Mitra A, Suarez-Sharp S, Pepin XJ, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, et al. Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to support Drug Product Quality: A Workshop Summary Report. Journal of Pharmaceutical Sciences. PMID 33152375 DOI: 10.1016/j.xphs.2020.10.059  0.361
2020 Gajewska M, Blumenstein L, Kourentas A, Mueller-Zsigmondy M, Lorenzo S, Sinn A, Velinova M, Heimbach T. Physiologically Based Pharmacokinetic Modeling of Oral Absorption, pH, and Food Effect in Healthy Volunteers to Drive Alpelisib Formulation Selection. The Aaps Journal. 22: 134. PMID 33070288 DOI: 10.1208/s12248-020-00511-7  0.354
2020 Riedmaier AE, DeMent K, Huckle J, Bransford P, Stillhart C, Lloyd R, Alluri R, Basu S, Chen Y, Dhamankar V, Dodd S, Kulkarni P, Olivares-Morales A, Peng CC, Pepin X, ... ... Heimbach T, et al. Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective. The Aaps Journal. 22: 123. PMID 32981010 DOI: 10.1208/s12248-020-00508-2  0.307
2020 Siriwannakij N, Heimbach T, Serajuddin ATM. Aqueous Dissolution and Dispersion Behavior of Polyvinylpyrrolidone Vinyl Acetate-based Amorphous Solid Dispersion of Ritonavir Prepared by Hot-Melt Extrusion with and without Added Surfactants. Journal of Pharmaceutical Sciences. 110: 1480-1494. PMID 32827493 DOI: 10.1016/j.xphs.2020.08.007  0.455
2020 Ahmad A, Pepin X, Aarons L, Wang Y, Darwich AS, Wood JM, Tannergren C, Karlsson E, Patterson C, Thörn H, Ruston L, Mattinson A, Carlert S, Berg S, Murphy D, ... ... Heimbach T, et al. IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 4: Prediction accuracy and software comparisons with improved data and modelling strategies. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V. PMID 32805361 DOI: 10.1016/J.Ejpb.2020.08.006  0.351
2020 Jamei M, Abrahamsson B, Brown J, Bevernage J, Bolger MB, Heimbach T, Karlsson E, Kotzagiorgis E, Lindahl A, McAllister M, Mullin JM, Pepin X, Tistaert C, Turner DB, Kesisoglou F. Current status and future opportunities for incorporation of dissolution data in pbpk modeling for pharmaceutical development and regulatory applications: orbito consortium commentary. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V. PMID 32781025 DOI: 10.1016/j.ejpb.2020.08.005  0.378
2020 Samant TS, Huth F, Umehara K, Schiller H, Dhuria SV, Elmeliegy M, Miller M, Chakraborty A, Heimbach T, He H, Ji Y. Ribociclib Drug-Drug Interactions - Clinical Evaluations and PBPK Modeling to Guide Drug Labeling. Clinical Pharmacology and Therapeutics. PMID 32557601 DOI: 10.1002/cpt.1950  0.327
2020 Suarez-Sharp S, Lindahl A, Heimbach T, Rostami-Hodjegan A, Bolger MB, Ray Chaudhuri S, Hens B. Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives. Pharmaceutical Research. 37: 95. PMID 32405699 DOI: 10.1007/s11095-020-02814-y  0.387
2019 Mitra A, Parrott N, Miller N, Lloyd R, Tistaert C, Heimbach T, Ji Y, Kesisoglou F. Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs using Physiologically based Biopharmaceutics Modeling: Industry Case Studies. Journal of Pharmaceutical Sciences. PMID 31778721 DOI: 10.1016/j.xphs.2019.11.017  0.424
2019 Umehara K, Huth F, Jin Y, Schiller H, Aslanis V, Heimbach T, He H. Drug-drug interaction (DDI) assessments of ruxolitinib, a dual substrate of CYP3A4 and CYP2C9, using a verified physiologically based pharmacokinetic (PBPK) model to support regulatory submissions. Drug Metabolism and Personalized Therapy. PMID 31145690 DOI: 10.1515/dmpt-2018-0042  0.362
2019 Heimbach T, Suarez-Sharp S, Kakhi M, Holmstock N, Olivares-Morales A, Pepin X, Sjögren E, Tsakalozou E, Seo P, Li M, Zhang X, Lin HP, Montague T, Mitra A, Morris D, et al. Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report. The Aaps Journal. 21: 29. PMID 30746576 DOI: 10.1208/s12248-019-0298-x  0.38
2018 Dodd S, Kollipara S, Sanchez-Felix M, Kim H, Meng Q, Beato S, Heimbach T. Prediction of ARA/PPI Drug-Drug Interactions at the Drug Discovery and Development Interface. Journal of Pharmaceutical Sciences. PMID 30385285 DOI: 10.1016/j.xphs.2018.10.032  0.418
2018 Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, Kotzagiorgis E, Li M, Nordmark A, Bandi N, Sjögren E, Babiskin A, Heimbach T, Kijima S, Mandula H, et al. Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report. The Aaps Journal. 20: 93. PMID 30151612 DOI: 10.1208/S12248-018-0252-3  0.421
2018 Abend A, Heimbach T, Cohen M, Kesisoglou F, Pepin X, Suarez-Sharp S. Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report. The Aaps Journal. 20: 60. PMID 29633092 DOI: 10.1208/s12248-018-0213-x  0.387
2018 Umehara KI, Huth F, Won CS, Heimbach T, He H. Verification of a physiologically-based pharmacokinetic model of ritonavir to estimate drug-drug interaction potential of CYP3A4 substrates. Biopharmaceutics & Drug Disposition. PMID 29451681 DOI: 10.1002/bdd.2122  0.441
2017 Wu F, Heimbach T, Hatsis P, Tang HM, Dugyala R, Yue Q, Wang T, He H. Integrated TK-TD modeling for drug-induced concurrent tachycardia and QT changes in beagle dogs. Journal of Pharmacokinetics and Pharmacodynamics. PMID 28643108 DOI: 10.1007/s10928-017-9532-2  0.411
2017 He H, Tran P, Gu H, Tedesco V, Zhang J, Lin W, Gatlik E, Klein K, Heimbach T. Midostaurin, a Novel Protein Kinase Inhibitor for the Treatment of Acute Myelogenous Leukemia: Insights from Human Absorption, Metabolism and Excretion Studies of a BDDCS II Drug. Drug Metabolism and Disposition: the Biological Fate of Chemicals. PMID 28270565 DOI: 10.1124/dmd.116.072744  0.364
2017 Lin W, Ji T, Einolf H, Ayalasomayajula S, Lin TH, Hanna I, Heimbach T, Breen C, Jarugula V, He H. Evaluation of drug-drug interaction potential between sacubitril/valsartan (LCZ696) and statins using a physiologically-based pharmacokinetic model. Journal of Pharmaceutical Sciences. PMID 28089685 DOI: 10.1016/J.Xphs.2017.01.007  0.385
2016 Kesisoglou F, Chung J, van Asperen J, Heimbach T. Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development-Industry Case Studies. Journal of Pharmaceutical Sciences. PMID 26886317 DOI: 10.1016/j.xphs.2015.11.034  0.433
2014 Becker D, Zhang J, Heimbach T, Penland RC, Wanke C, Shimizu J, Kulmatycki K. Novel orally swallowable IntelliCap(®) device to quantify regional drug absorption in human GI tract using diltiazem as model drug. Aaps Pharmscitech. 15: 1490-7. PMID 25023947 DOI: 10.1208/S12249-014-0172-1  0.457
2014 Xia B, Barve A, Heimbach T, Zhang T, Gu H, Wang L, Einolf H, Alexander N, Hanna I, Ke J, Mangold JB, He H, Sunkara G. Physiologically based pharmacokinetic modeling for assessing the clinical drug-drug interaction of alisporivir. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation For Pharmaceutical Sciences. 63: 103-12. PMID 25008118 DOI: 10.1016/J.Ejps.2014.06.021  0.437
2008 Rautio J, Kumpulainen H, Heimbach T, Oliyai R, Oh D, Järvinen T, Savolainen J. Prodrugs: design and clinical applications. Nature Reviews. Drug Discovery. 7: 255-70. PMID 18219308 DOI: 10.1038/nrd2468  0.453
2006 Kaddoumi A, Fleisher D, Heimbach T, Li LY, Cole S. Factors influencing regional differences in intestinal absorption of UK-343,664 in rat: possible role in dose-dependent pharmacokinetics. Journal of Pharmaceutical Sciences. 95: 435-45. PMID 16381015 DOI: 10.1002/Jps.20527  0.341
2003 Heimbach T, Oh DM, Li LY, Rodríguez-Hornedo N, Garcia G, Fleisher D. Enzyme-mediated precipitation of parent drugs from their phosphate prodrugs. International Journal of Pharmaceutics. 261: 81-92. PMID 12878397 DOI: 10.1016/S0378-5173(03)00287-4  0.526
2003 Heimbach T, Oh DM, Li LY, Forsberg M, Savolainen J, Leppänen J, Matsunaga Y, Flynn G, Fleisher D. Absorption rate limit considerations for oral phosphate prodrugs Pharmaceutical Research. 20: 848-856. PMID 12817887 DOI: 10.1023/A:1023827017224  0.414
2002 Li LY, Amidon GL, Kim JS, Heimbach T, Kesisoglou F, Topliss JT, Fleisher D. Intestinal metabolism promotes regional differences in apical uptake of indinavir: coupled effect of P-glycoprotein and cytochrome P450 3A on indinavir membrane permeability in rat. The Journal of Pharmacology and Experimental Therapeutics. 301: 586-93. PMID 11961060 DOI: 10.1124/Jpet.301.2.586  0.325
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