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Parathyroid hormone (1-34)-coated microneedle patch system: clinical pharmacokinetics and pharmacodynamics for treatment of osteoporosis.
Daddona PE, Matriano JA, Mandema J, Maa YF. Daddona PE, et al. Among authors: mandema j. Pharm Res. 2011 Jan;28(1):159-65. doi: 10.1007/s11095-010-0192-9. Epub 2010 Jun 22. Pharm Res. 2011. PMID: 20567999 Clinical Trial.
The use of clinical trial simulation to support dose selection: application to development of a new treatment for chronic neuropathic pain.
Lockwood PA, Cook JA, Ewy WE, Mandema JW. Lockwood PA, et al. Pharm Res. 2003 Nov;20(11):1752-9. doi: 10.1023/b:pham.0000003371.32474.ee. Pharm Res. 2003. PMID: 14661918
Time course of bone mineral density changes with denosumab compared with other drugs in postmenopausal osteoporosis: a dose-response-based meta-analysis.
Mandema JW, Zheng J, Libanati C, Perez Ruixo JJ. Mandema JW, et al. J Clin Endocrinol Metab. 2014 Oct;99(10):3746-55. doi: 10.1210/jc.2013-3795. Epub 2014 Jun 10. J Clin Endocrinol Metab. 2014. PMID: 24915115
Prediction of clinical irrelevance of PK differences in atorvastatin using PK/PD models derived from literature-based meta-analyses.
Vargo R, Adewale A, Behm MO, Mandema J, Kerbusch T. Vargo R, et al. Among authors: mandema j. Clin Pharmacol Ther. 2014 Jul;96(1):101-9. doi: 10.1038/clpt.2014.66. Epub 2014 Mar 28. Clin Pharmacol Ther. 2014. PMID: 24682029 Free PMC article.
Quantitative Evaluations of Time-Course and Treatment Effects of Systemic Agents for Psoriasis: A Model-Based Meta-Analysis.
Checchio T, Ahadieh S, Gupta P, Mandema J, Puig L, Wolk R, Valdez H, Tan H, Krishnaswami S, Tallman A, Kaur M, Ito K. Checchio T, et al. Among authors: mandema j. Clin Pharmacol Ther. 2017 Dec;102(6):1006-1016. doi: 10.1002/cpt.732. Epub 2017 Jun 21. Clin Pharmacol Ther. 2017. PMID: 28480503 Free PMC article. Review.
Short-Term Efficacy Reliably Predicts Long-Term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-Based Meta-Analysis.
Wang Y, Zhu R, Xiao J, Davis JC Jr, Mandema JW, Jin JY, Tang MT. Wang Y, et al. Among authors: mandema jw. J Clin Pharmacol. 2016 Jul;56(7):835-44. doi: 10.1002/jcph.668. Epub 2015 Dec 31. J Clin Pharmacol. 2016. PMID: 26517752 Free PMC article.
Similar relationship between the time course of bone mineral density improvement and vertebral fracture risk reduction with denosumab treatment in postmenopausal osteoporosis and prostate cancer patients on androgen deprivation therapy.
Pérez Ruixo JJ, Zheng J, Mandema JW. Pérez Ruixo JJ, et al. Among authors: mandema jw. J Clin Pharmacol. 2014 May;54(5):503-12. doi: 10.1002/jcph.228. Epub 2013 Nov 30. J Clin Pharmacol. 2014. PMID: 24214315 Clinical Trial.
Model-based drug development: a rational approach to efficiently accelerate drug development.
Milligan PA, Brown MJ, Marchant B, Martin SW, van der Graaf PH, Benson N, Nucci G, Nichols DJ, Boyd RA, Mandema JW, Krishnaswami S, Zwillich S, Gruben D, Anziano RJ, Stock TC, Lalonde RL. Milligan PA, et al. Among authors: mandema jw. Clin Pharmacol Ther. 2013 Jun;93(6):502-14. doi: 10.1038/clpt.2013.54. Epub 2013 Mar 14. Clin Pharmacol Ther. 2013. PMID: 23588322
Model-based development of gemcabene, a new lipid-altering agent.
Mandema JW, Hermann D, Wang W, Sheiner T, Milad M, Bakker-Arkema R, Hartman D. Mandema JW, et al. AAPS J. 2005 Oct 7;7(3):E513-22. doi: 10.1208/aapsj070352. AAPS J. 2005. PMID: 16353929 Free PMC article. Review.
Modeling the onset and offset of dental pain relief by ibuprofen.
Li H, Mandema J, Wada R, Jayawardena S, Desjardins P, Doyle G, Kellstein D. Li H, et al. Among authors: mandema j. J Clin Pharmacol. 2012 Jan;52(1):89-101. doi: 10.1177/0091270010389470. Epub 2011 Mar 7. J Clin Pharmacol. 2012. PMID: 21383341 Clinical Trial.
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