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Items: 37

1.

Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report.

Abend A, Heimbach T, Cohen M, Kesisoglou F, Pepin X, Suarez-Sharp S.

AAPS J. 2018 Apr 9;20(3):60. doi: 10.1208/s12248-018-0213-x.

PMID:
29633092
2.

Verification of a physiologically based pharmacokinetic model of ritonavir to estimate drug-drug interaction potential of CYP3A4 substrates.

Umehara KI, Huth F, Won CS, Heimbach T, He H.

Biopharm Drug Dispos. 2018 Mar;39(3):152-163. doi: 10.1002/bdd.2122.

PMID:
29451681
3.

Estimation of fractions metabolized by hepatic CYP enzymes using a concept of inter-system extrapolation factors (ISEFs) - a comparison with the chemical inhibition method.

Umehara KI, Huth F, Gu H, Schiller H, Heimbach T, He H.

Drug Metab Pers Ther. 2017 Dec 20;32(4):191-200. doi: 10.1515/dmpt-2017-0024.

PMID:
29176011
4.

Discovery and Evaluation of Clinical Candidate IDH305, a Brain Penetrant Mutant IDH1 Inhibitor.

Cho YS, Levell JR, Liu G, Caferro T, Sutton J, Shafer CM, Costales A, Manning JR, Zhao Q, Sendzik M, Shultz M, Chenail G, Dooley J, Villalba B, Farsidjani A, Chen J, Kulathila R, Xie X, Dodd S, Gould T, Liang G, Heimbach T, Slocum K, Firestone B, Pu M, Pagliarini R, Growney JD.

ACS Med Chem Lett. 2017 Sep 18;8(10):1116-1121. doi: 10.1021/acsmedchemlett.7b00342. eCollection 2017 Oct 12.

PMID:
29057061
5.

Integrated TK-TD modeling for drug-induced concurrent tachycardia and QT changes in beagle dogs.

Wu F, Heimbach T, Hatsis P, Tang HM, Dugyala R, Yue Q, Wang T, He H.

J Pharmacokinet Pharmacodyn. 2017 Oct;44(5):449-462. doi: 10.1007/s10928-017-9532-2. Epub 2017 Jun 22.

PMID:
28643108
6.

Food effects in paediatric medicines development for products Co-administered with food.

Batchelor H, Kaukonen AM, Klein S, Davit B, Ju R, Ternik R, Heimbach T, Lin W, Wang J, Storey D.

Int J Pharm. 2018 Feb 5;536(2):530-535. doi: 10.1016/j.ijpharm.2017.05.011. Epub 2017 May 8.

PMID:
28495584
7.

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.

He H, Tran P, Gu H, Tedesco V, Zhang J, Lin W, Gatlik E, Klein K, Heimbach T.

Drug Metab Dispos. 2017 May;45(5):540-555. doi: 10.1124/dmd.116.072744. Epub 2017 Mar 7.

8.

Evaluation of Drug-Drug Interaction Potential Between Sacubitril/Valsartan (LCZ696) and Statins Using a Physiologically Based Pharmacokinetic Model.

Lin W, Ji T, Einolf H, Ayalasomayajula S, Lin TH, Hanna I, Heimbach T, Breen C, Jarugula V, He H.

J Pharm Sci. 2017 May;106(5):1439-1451. doi: 10.1016/j.xphs.2017.01.007. Epub 2017 Jan 13.

PMID:
28089685
9.

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results.

Margolskee A, Darwich AS, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, Carlert S, Hammarberg M, Hilgendorf C, Johansson P, Karlsson E, Murphy D, Tannergren C, Thörn H, Yasin M, Mazuir F, Nicolas O, Ramusovic S, Xu C, Pathak SM, Korjamo T, Laru J, Malkki J, Pappinen S, Tuunainen J, Dressman J, Hansmann S, Kostewicz E, He H, Heimbach T, Wu F, Hoft C, Laplanche L, Pang Y, Bolger MB, Huehn E, Lukacova V, Mullin JM, Szeto KX, Costales C, Lin J, McAllister M, Modi S, Rotter C, Varma M, Wong M, Mitra A, Bevernage J, Biewenga J, Van Peer A, Lloyd R, Shardlow C, Langguth P, Mishenzon I, Nguyen MA, Brown J, Lennernäs H, Abrahamsson B.

Eur J Pharm Sci. 2017 Jan 1;96:610-625. doi: 10.1016/j.ejps.2016.10.036. Epub 2016 Nov 2.

PMID:
27816631
10.

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes.

Darwich AS, Margolskee A, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, Carlert S, Hammarberg M, Hilgendorf C, Johansson P, Karlsson E, Murphy D, Tannergren C, Thörn H, Yasin M, Mazuir F, Nicolas O, Ramusovic S, Xu C, Pathak SM, Korjamo T, Laru J, Malkki J, Pappinen S, Tuunainen J, Dressman J, Hansmann S, Kostewicz E, He H, Heimbach T, Wu F, Hoft C, Pang Y, Bolger MB, Huehn E, Lukacova V, Mullin JM, Szeto KX, Costales C, Lin J, McAllister M, Modi S, Rotter C, Varma M, Wong M, Mitra A, Bevernage J, Biewenga J, Van Peer A, Lloyd R, Shardlow C, Langguth P, Mishenzon I, Nguyen MA, Brown J, Lennernäs H, Abrahamsson B.

Eur J Pharm Sci. 2017 Jan 1;96:626-642. doi: 10.1016/j.ejps.2016.09.037. Epub 2016 Sep 28.

PMID:
27693299
11.

Antiviral Nucleotide Incorporation by Recombinant Human Mitochondrial RNA Polymerase Is Predictive of Increased In Vivo Mitochondrial Toxicity Risk.

Fenaux M, Lin X, Yokokawa F, Sweeney Z, Saunders O, Xie L, Lim SP, Uteng M, Uehara K, Warne R, Gang W, Jones C, Yendluri S, Gu H, Mansfield K, Boisclair J, Heimbach T, Catoire A, Bracken K, Weaver M, Moser H, Zhong W.

Antimicrob Agents Chemother. 2016 Nov 21;60(12):7077-7085. Print 2016 Dec.

12.

A Physiologically Based Pharmacokinetic Model to Describe Artemether Pharmacokinetics in Adult and Pediatric Patients.

Lin W, Heimbach T, Jain JP, Awasthi R, Hamed K, Sunkara G, He H.

J Pharm Sci. 2016 Oct;105(10):3205-3213. doi: 10.1016/j.xphs.2016.06.026. Epub 2016 Aug 6.

13.

Clinical Exposure Boost Predictions by Integrating Cytochrome P450 3A4-Humanized Mouse Studies With PBPK Modeling.

Zhang J, Heimbach T, Scheer N, Barve A, Li W, Lin W, He H.

J Pharm Sci. 2016 Apr;105(4):1398-404. doi: 10.1016/j.xphs.2016.01.021.

PMID:
27019957
14.

Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development-Industry Case Studies.

Kesisoglou F, Chung J, van Asperen J, Heimbach T.

J Pharm Sci. 2016 Sep;105(9):2723-2734. doi: 10.1016/j.xphs.2015.11.034. Epub 2016 Jan 23.

PMID:
26886317
15.

Prospective Predictions of Human Pharmacokinetics for Eighteen Compounds.

Zhang T, Heimbach T, Lin W, Zhang J, He H.

J Pharm Sci. 2015 Sep;104(9):2795-806. doi: 10.1002/jps.24373. Epub 2015 Feb 17.

PMID:
25690565
16.

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

Jones HM, Chen Y, Gibson C, Heimbach T, Parrott N, Peters SA, Snoeys J, Upreti VV, Zheng M, Hall SD.

Clin Pharmacol Ther. 2015 Mar;97(3):247-62. doi: 10.1002/cpt.37. Epub 2015 Jan 9. Review.

PMID:
25670209
17.

Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape.

Schuck E, Bohnert T, Chakravarty A, Damian-Iordache V, Gibson C, Hsu CP, Heimbach T, Krishnatry AS, Liederer BM, Lin J, Maurer T, Mettetal JT, Mudra DR, Nijsen MJ, Raybon J, Schroeder P, Schuck V, Suryawanshi S, Su Y, Trapa P, Tsai A, Vakilynejad M, Wang S, Wong H.

AAPS J. 2015 Mar;17(2):462-73. doi: 10.1208/s12248-014-9716-2. Epub 2015 Jan 29.

18.

Novel orally swallowable IntelliCap(®) device to quantify regional drug absorption in human GI tract using diltiazem as model drug.

Becker D, Zhang J, Heimbach T, Penland RC, Wanke C, Shimizu J, Kulmatycki K.

AAPS PharmSciTech. 2014 Dec;15(6):1490-7. doi: 10.1208/s12249-014-0172-1. Epub 2014 Jul 15.

19.

Physiologically based pharmacokinetic modeling for assessing the clinical drug-drug interaction of alisporivir.

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.

Eur J Pharm Sci. 2014 Oct 15;63:103-12. doi: 10.1016/j.ejps.2014.06.021. Epub 2014 Jul 4.

PMID:
25008118
20.

Application of physiologically based absorption modeling to formulation development of a low solubility, low permeability weak base: mechanistic investigation of food effect.

Zhang H, Xia B, Sheng J, Heimbach T, Lin TH, He H, Wang Y, Novick S, Comfort A.

AAPS PharmSciTech. 2014 Apr;15(2):400-6. doi: 10.1208/s12249-014-0075-1. Epub 2014 Jan 17.

21.

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 TH, Li S, Zhang H, Sheng J, He H.

AAPS PharmSciTech. 2013 Sep;14(3):1255-66. doi: 10.1208/s12249-013-0018-2. Epub 2013 Aug 17.

22.

A simplified PBPK modeling approach for prediction of pharmacokinetics of four primarily renally excreted and CYP3A metabolized compounds during pregnancy.

Xia B, Heimbach T, Gollen R, Nanavati C, He H.

AAPS J. 2013 Oct;15(4):1012-24. doi: 10.1208/s12248-013-9505-3. Epub 2013 Jul 9.

23.

Case studies for practical food effect assessments across BCS/BDDCS class compounds using in silico, in vitro, and preclinical in vivo data.

Heimbach T, Xia B, Lin TH, He H.

AAPS J. 2013 Jan;15(1):143-58. doi: 10.1208/s12248-012-9419-5. Epub 2012 Nov 10.

24.

Nilotinib preclinical pharmacokinetics and practical application toward clinical projections of oral absorption and systemic availability.

Xia B, Heimbach T, He H, Lin TH.

Biopharm Drug Dispos. 2012 Dec;33(9):536-49. doi: 10.1002/bdd.1821. Epub 2012 Nov 19.

PMID:
23097199
25.

Novel physiologically based pharmacokinetic modeling of patupilone for human pharmacokinetic predictions.

Xia B, Heimbach T, Lin TH, He H, Wang Y, Tan E.

Cancer Chemother Pharmacol. 2012 Jun;69(6):1567-82. doi: 10.1007/s00280-012-1863-5. Epub 2012 Apr 11.

PMID:
22526410
26.

Pharmacokinetics of dietary cancer chemopreventive compound dibenzoylmethane in rats and the impact of nanoemulsion and genetic knockout of Nrf2 on its disposition.

Lin W, Hong JL, Shen G, Wu RT, Wang Y, Huang MT, Newmark HL, Huang Q, Khor TO, Heimbach T, Kong AN.

Biopharm Drug Dispos. 2011 Mar;32(2):65-75. doi: 10.1002/bdd.734. Epub 2010 Dec 16.

27.

Practical anticipation of human efficacious doses and pharmacokinetics using in vitro and preclinical in vivo data.

Heimbach T, Lakshminarayana SB, Hu W, He H.

AAPS J. 2009 Sep;11(3):602-14. doi: 10.1208/s12248-009-9136-x. Epub 2009 Aug 26.

28.

Prodrugs: design and clinical applications.

Rautio J, Kumpulainen H, Heimbach T, Oliyai R, Oh D, Järvinen T, Savolainen J.

Nat Rev Drug Discov. 2008 Mar;7(3):255-70. doi: 10.1038/nrd2468. Review. Erratum in: Nat Rev Drug Discov. 2008 Mar;7(3):272.

PMID:
18219308
29.

Automated approach to couple solubility with final pH and crystallinity for pharmaceutical discovery compounds.

Seadeek C, Ando H, Bhattachar SN, Heimbach T, Sonnenberg JL, Blackburn AC.

J Pharm Biomed Anal. 2007 Apr 11;43(5):1660-6. Epub 2007 Jan 5.

PMID:
17270379
30.
31.

Validation of a semi-automated human hepatocyte assay for the determination and prediction of intrinsic clearance in discovery.

Reddy A, Heimbach T, Freiwald S, Smith D, Winters R, Michael S, Surendran N, Cai H.

J Pharm Biomed Anal. 2005 Feb 23;37(2):319-26.

PMID:
15708673
32.

Enzyme-mediated precipitation of parent drugs from their phosphate prodrugs.

Heimbach T, Oh DM, Li LY, Rodríguez-Hornedo N, Garcia G, Fleisher D.

Int J Pharm. 2003 Aug 11;261(1-2):81-92.

PMID:
12878397
33.

In-vitro crystallization of indinavir in the presence of ritonavir and as a function of pH.

Li LY, Rodríguez-Hornedo N, Heimbach T, Fleisher D.

J Pharm Pharmacol. 2003 May;55(5):707-11.

PMID:
12831515
34.

Absorption rate limit considerations for oral phosphate prodrugs.

Heimbach T, Oh DM, Li LY, Forsberg M, Savolainen J, Leppänen J, Matsunaga Y, Flynn G, Fleisher D.

Pharm Res. 2003 Jun;20(6):848-56.

35.
36.

Design and synthesis of novel quinoxaline-2,3-dione AMPA/GlyN receptor antagonists: amino acid derivatives.

Nikam SS, Cordon JJ, Ortwine DF, Heimbach TH, Blackburn AC, Vartanian MG, Nelson CB, Schwarz RD, Boxer PA, Rafferty MF.

J Med Chem. 1999 Jun 17;42(12):2266-71.

PMID:
10377233
37.

pKa determinations by using a HPLC equipped with DAD as a flow injection apparatus.

Ando HY, Heimbach T.

J Pharm Biomed Anal. 1997 Sep;16(1):31-7.

PMID:
9447549

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