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Items: 26

1.

Coadministration of the prostaglandin F2α receptor antagonist preterm labour drug candidate OBE022 with magnesium sulfate, atosiban, nifedipine and betamethasone.

Pohl O, Marchand L, Gotteland JP, Coates S, Täubel J, Lorch U.

Br J Clin Pharmacol. 2019 Jul;85(7):1516-1527. doi: 10.1111/bcp.13925. Epub 2019 May 11.

PMID:
30891820
2.

Efficient Design of Integrated and Adaptively Interlinked Protocols for Early-Phase Drug Development Programs.

Coates S, Pohl O, Gotteland JP, Täubel J, Lorch U.

Ther Innov Regul Sci. 2019 Jan 27:2168479018821087. doi: 10.1177/2168479018821087. [Epub ahead of print]

PMID:
30686046
3.

Practical risk management in early phase clinical trials.

Coates S, Täubel J, Lorch U.

Eur J Clin Pharmacol. 2019 Apr;75(4):483-496. doi: 10.1007/s00228-018-02607-8. Epub 2018 Dec 19.

PMID:
30569285
4.

The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting 2018: Brexit and Other Challenges in Early Phase Drug Development.

Reijntjes S, Albayaty M, Bush J, Cheriyan J, Cromie A, Koch A, Hammond M, Mair S, Scholes P, Lorch U, Stringer S, Taubel J, Hardman TC.

Front Pharmacol. 2018 Nov 19;9:1301. doi: 10.3389/fphar.2018.01301. eCollection 2018. Review.

5.

Pharmacokinetics of Tramadol and Celecoxib in Japanese and Caucasian Subjects Following Administration of Co-Crystal of Tramadol-Celecoxib (CTC): A Randomised, Open-Label Study.

Dooner H, Mundin G, Mersmann S, Bennett C, Lorch U, Encabo M, Escriche M, Encina G, Smith K.

Eur J Drug Metab Pharmacokinet. 2019 Feb;44(1):63-75. doi: 10.1007/s13318-018-0491-9.

6.

A first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition.

Cuvier V, Lorch U, Witte S, Olivier A, Gibot S, Delor I, Garaud JJ, Derive M, Salcedo-Magguilli M.

Br J Clin Pharmacol. 2018 Oct;84(10):2270-2279. doi: 10.1111/bcp.13668. Epub 2018 Jul 20.

7.

Pharmacokinetics, safety and tolerability of OBE022, a selective prostaglandin F2α receptor antagonist tocolytic: A first-in-human trial in healthy postmenopausal women.

Pohl O, Marchand L, Gotteland JP, Coates S, Täubel J, Lorch U.

Br J Clin Pharmacol. 2018 Aug;84(8):1839-1855. doi: 10.1111/bcp.13622. Epub 2018 Jun 5.

8.

Confirmation of the Cardiac Safety of PGF Receptor Antagonist OBE022 in a First-in-Human Study in Healthy Subjects, Using Intensive ECG Assessments.

Täubel J, Lorch U, Coates S, Fernandes S, Foley P, Ferber G, Gotteland JP, Pohl O.

Clin Pharmacol Drug Dev. 2018 Nov;7(8):889-900. doi: 10.1002/cpdd.447. Epub 2018 Feb 28.

9.

Pharmacokinetics of concentrated naloxone nasal spray for opioid overdose reversal: Phase I healthy volunteer study.

McDonald R, Lorch U, Woodward J, Bosse B, Dooner H, Mundin G, Smith K, Strang J.

Addiction. 2018 Mar;113(3):484-493. doi: 10.1111/add.14033. Epub 2017 Nov 16.

10.

Pharmacokinetics and pharmacogenetics of the MEK1/2 inhibitor, selumetinib, in Asian and Western healthy subjects: a pooled analysis.

Dymond AW, Elks C, Martin P, Carlile DJ, Mariani G, Lovick S, Huang Y, Lorch U, Brown H, So K.

Eur J Clin Pharmacol. 2017 Jun;73(6):717-726. doi: 10.1007/s00228-017-2217-3. Epub 2017 Mar 10.

11.

Thorough QT study of the effect of intravenous amisulpride on QTc interval in Caucasian and Japanese healthy subjects.

Täubel J, Ferber G, Fox G, Fernandes S, Lorch U, Camm AJ.

Br J Clin Pharmacol. 2017 Feb;83(2):339-348. doi: 10.1111/bcp.13128. Epub 2016 Oct 21.

12.

Pharmacokinetics, Safety and Cognitive Function Profile of Rupatadine 10, 20 and 40 mg in Healthy Japanese Subjects: A Randomised Placebo-Controlled Trial.

Täubel J, Ferber G, Fernandes S, Lorch U, Santamaría E, Izquierdo I.

PLoS One. 2016 Sep 15;11(9):e0163020. doi: 10.1371/journal.pone.0163020. eCollection 2016.

13.

Pharmacokinetics and Pharmacodynamics of Lomitapide in Japanese Subjects.

Taubel J, Sumeray M, Lorch U, McLean A.

J Atheroscler Thromb. 2016 May 2;23(5):606-20. doi: 10.5551/jat.30452. Epub 2015 Dec 18.

14.

The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study.

Ferber G, Lorch U, Täubel J.

Biomed Res Int. 2015;2015:293564. doi: 10.1155/2015/293564. Epub 2015 Oct 5.

16.

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines.

Lorch U, O'Kane M, Taubel J.

BMC Med Res Methodol. 2014 Jun 30;14:84. doi: 10.1186/1471-2288-14-84.

17.

Analyzing the relationship of QT interval and exposure to nitazoxanide, a prospective candidate for influenza antiviral therapy--A formal TQT study.

Täubel J, Lorch U, Rossignol JF, Ferber G, Camm AJ.

J Clin Pharmacol. 2014 Sep;54(9):987-94. doi: 10.1002/jcph.300. Epub 2014 Apr 15.

PMID:
24691901
18.

Thorough QT study of the effect of oral moxifloxacin on QTc interval in the fed and fasted state in healthy Japanese and Caucasian subjects.

Taubel J, Ferber G, Lorch U, Batchvarov V, Savelieva I, Camm AJ.

Br J Clin Pharmacol. 2014 Jan;77(1):170-9. doi: 10.1111/bcp.12168.

19.

Insulin at normal physiological levels does not prolong QT(c) interval in thorough QT studies performed in healthy volunteers.

Taubel J, Lorch U, Ferber G, Singh J, Batchvarov VN, Savelieva I, Camm AJ.

Br J Clin Pharmacol. 2013 Feb;75(2):392-403. doi: 10.1111/j.1365-2125.2012.04376.x.

20.

Repeated supratherapeutic dosing of strontium ranelate over 15 days does not prolong QT(c) interval in healthy volunteers.

Taubel J, Naseem A, Wang D, Arezina R, Lorch U, Camm AJ.

Br J Clin Pharmacol. 2012 Aug;74(2):296-303. doi: 10.1111/j.1365-2125.2012.04190.x.

21.

The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings.

Lorch U, Berelowitz K, Ozen C, Naseem A, Akuffo E, Taubel J.

Eur J Clin Pharmacol. 2012 May;68(5):543-51. doi: 10.1007/s00228-011-1176-3. Epub 2011 Nov 25.

PMID:
22116461
22.

Bupivacaine extended release liposome injection does not prolong QTc interval in a thorough QT/QTc study in healthy volunteers.

Naseem A, Harada T, Wang D, Arezina R, Lorch U, Onel E, Camm AJ, Taubel J.

J Clin Pharmacol. 2012 Sep;52(9):1441-7. doi: 10.1177/0091270011419853. Epub 2011 Nov 4. No abstract available.

PMID:
22058388
23.

Levofloxacin can be used effectively as a positive control in thorough QT/QTc studies in healthy volunteers.

Taubel J, Naseem A, Harada T, Wang D, Arezina R, Lorch U, Camm AJ.

Br J Clin Pharmacol. 2010 Apr;69(4):391-400. doi: 10.1111/j.1365-2125.2009.03595.x.

24.

Similar rivastigmine pharmacokinetics and pharmacodynamics in Japanese and white healthy participants following the application of novel rivastigmine patch.

Lefèvre G, Büche M, Sedek G, Maton S, Enz A, Lorch U, Sagan C, Appel-Dingemanse S.

J Clin Pharmacol. 2009 Apr;49(4):430-43. doi: 10.1177/0091270008330161. Epub 2009 Feb 26.

PMID:
19246725
25.

Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects.

Dixon R, Job S, Oliver R, Tompson D, Wright JG, Maltby K, Lorch U, Taubel J.

Br J Clin Pharmacol. 2008 Sep;66(3):396-404. doi: 10.1111/j.1365-2125.2008.03250.x. Epub 2008 Jul 23.

26.

The suppression of gastro-oesophageal reflux by alginates.

Dettmar PW, Hampson FC, Taubel J, Lorch U, Johnstone LM, Sykes J, Berry PJ.

Int J Clin Pract. 2007 Oct;61(10):1654-62. Epub 2007 Aug 6.

PMID:
17681004

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