Bjerrum OJ - Search Results

1

Body of evidence and approaches applied in the clinical development programme of fixed-dose combinations in the European Union from 2010 to 2016.

Nøhr-Nielsen A, De Bruin ML, Thomsen M, Pipper CB, Lange T, Bjerrum OJ, Lund TM. Nøhr-Nielsen A, et al. Among authors: bjerrum oj. Br J Clin Pharmacol. 2019 Aug;85(8):1829-1840. doi: 10.1111/bcp.13986. Epub 2019 Jun 17. Br J Clin Pharmacol. 2019. PMID: 31077427 Free PMC article.

2

Demonstrating Contribution of Components of Fixed-Dose Drug Combinations Through Longitudinal Exposure-Response Analysis.

Nøhr-Nielsen A, Lange T, Forman JL, Papathanasiou T, Foster DJR, Upton RN, Bjerrum OJ, Lund TM. Nøhr-Nielsen A, et al. Among authors: bjerrum oj. AAPS J. 2020 Jan 27;22(2):32. doi: 10.1208/s12248-020-0414-y. AAPS J. 2020. PMID: 31989328

3

How first-time-in-human studies are being performed: a survey of phase I dose-escalation trials in healthy volunteers published between 1995 and 2004.

Buoen C, Bjerrum OJ, Thomsen MS. Buoen C, et al. Among authors: bjerrum oj. J Clin Pharmacol. 2005 Oct;45(10):1123-36. doi: 10.1177/0091270005279943. J Clin Pharmacol. 2005. PMID: 16172177

4

An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009-2014: A Focus on Benefit-Risk and Clinical Development Conditions.

Sawicki-Wrzask D, Thomsen M, Bjerrum OJ. Sawicki-Wrzask D, et al. Among authors: bjerrum oj. Ther Innov Regul Sci. 2015 Jul;49(4):553-559. doi: 10.1177/2168479014567322. Ther Innov Regul Sci. 2015. PMID: 30222435

5

Analysis of the Authorized Target Populations for Fixed Dose Combination Products Between 2000 and 2017 Reveals Discrepancies Between EMA's and FDA's Views on Initial Dual-Therapy.

Bjerrum OJ, Eichendorff S, Alkis NB. Bjerrum OJ, et al. Ther Innov Regul Sci. 2020 Mar;54(2):297-302. doi: 10.1007/s43441-019-00057-7. Epub 2020 Jan 6. Ther Innov Regul Sci. 2020. PMID: 32072578

6

The Wider Use of Fixed-Dose Combinations Emphasizes the Need for a Global Approach to Regulatory Guideline Development.

Gautam Y, Bjerrum OJ, Schmiegelow M. Gautam Y, et al. Among authors: bjerrum oj. Ther Innov Regul Sci. 2015 Jan;49(1):197-204. doi: 10.1177/2168479014543699. Ther Innov Regul Sci. 2015. PMID: 30222451

7

New safe medicines faster: A proposal for a key action within the European union's 6th framework programme.

Bjerrum OJ. Bjerrum OJ. Pharmacol Toxicol. 2000;86 Suppl 1:23-6. Pharmacol Toxicol. 2000. PMID: 10905750

8

Medicines combinations options and regulatory hurdles.

Bjerrum OJ, Gautam Y, Bjerrum EJ, Schmiegelow M, Boonen HC. Bjerrum OJ, et al. Among authors: bjerrum ej. Eur J Pharm Sci. 2013 Jul 16;49(4):659-63. doi: 10.1016/j.ejps.2013.04.028. Epub 2013 May 3. Eur J Pharm Sci. 2013. PMID: 23643740 No abstract available.

9

Identifying Off-Label Prescriptions Through Data Mining in Danish Community Pharmacy Servers: An Exploratory Study on Desmopressin, Diclofenac, Fucidin, Mirtazapine and Quetiapine.

Andrulyte M, Bjerrum OJ. Andrulyte M, et al. Among authors: bjerrum oj. Basic Clin Pharmacol Toxicol. 2018 Aug;123(2):155-160. doi: 10.1111/bcpt.13009. Epub 2018 Apr 25. Basic Clin Pharmacol Toxicol. 2018. PMID: 29575543 Free article.

10

Differential effects of repeated low dose treatment with the cannabinoid agonist WIN 55,212-2 in experimental models of bone cancer pain and neuropathic pain.

Hald A, Ding M, Egerod K, Hansen RR, Konradsen D, Jørgensen SG, Atalay B, Nasser A, Bjerrum OJ, Heegaard AM. Hald A, et al. Among authors: bjerrum oj. Pharmacol Biochem Behav. 2008 Nov;91(1):38-46. doi: 10.1016/j.pbb.2008.04.021. Epub 2008 Jun 20. Pharmacol Biochem Behav. 2008. PMID: 18611408

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