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Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both.
Woodcock J, LaVange LM. Woodcock J, et al. Among authors: lavange lm. N Engl J Med. 2017 Jul 6;377(1):62-70. doi: 10.1056/NEJMra1510062. N Engl J Med. 2017. PMID: 28679092 No abstract available.
Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.
Amur S, LaVange L, Zineh I, Buckman-Garner S, Woodcock J. Amur S, et al. Clin Pharmacol Ther. 2015 Jul;98(1):34-46. doi: 10.1002/cpt.136. Epub 2015 Jun 6. Clin Pharmacol Ther. 2015. PMID: 25868461 Review.
Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products.
Gamalo MA, Tiwari RC, LaVange LM. Gamalo MA, et al. Among authors: lavange lm. Pharm Stat. 2014 Jan-Feb;13(1):25-40. doi: 10.1002/pst.1588. Epub 2013 Aug 5. Pharm Stat. 2014. PMID: 23913880
A regulatory perspective on missing data in the aftermath of the NRC report.
LaVange LM, Permutt T. LaVange LM, et al. Stat Med. 2016 Jul 30;35(17):2853-64. doi: 10.1002/sim.6840. Epub 2015 Dec 17. Stat Med. 2016. PMID: 26677837
Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.
Schuck RN, Woodcock J, Zineh I, Stein P, Jarow J, Temple R, Permutt T, LaVange L, Beaver JA, Charlab R, Blumenthal GM, Dorff SE, Leptak C, Lemery S, Rogers H, Chowdhury B, Litwack ED, Pacanowski M. Schuck RN, et al. Clin Pharmacol Ther. 2018 Aug;104(2):282-289. doi: 10.1002/cpt.1041. Epub 2018 Feb 23. Clin Pharmacol Ther. 2018. PMID: 29473145 Free PMC article. Review.
Real-World Evidence - What Is It and What Can It Tell Us?
Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Sherman RE, et al. N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216. N Engl J Med. 2016. PMID: 27959688 No abstract available.
Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data.
Jarow JP, LaVange L, Woodcock J. Jarow JP, et al. JAMA. 2017 Aug 22;318(8):703-704. doi: 10.1001/jama.2017.9991. JAMA. 2017. PMID: 28715550 No abstract available.
Flexible shrinkage estimation of subgroup effects through Dirichlet process priors.
Gamalo-Siebers M, Tiwari R, LaVange L. Gamalo-Siebers M, et al. J Biopharm Stat. 2016;26(6):1040-1055. doi: 10.1080/10543406.2016.1226327. Epub 2016 Aug 22. J Biopharm Stat. 2016. PMID: 27548701
An overview of statistical issues and methods of meta-analysis.
Schmid JE, Koch GG, LaVange LM. Schmid JE, et al. Among authors: lavange lm. J Biopharm Stat. 1991;1(1):103-20. doi: 10.1080/10543409108835008. J Biopharm Stat. 1991. PMID: 1844682 Review.
Applying sample survey methods to clinical trials data.
LaVange LM, Koch GG, Schwartz TA. LaVange LM, et al. Stat Med. 2001 Sep 15-30;20(17-18):2609-23. doi: 10.1002/sim.732. Stat Med. 2001. PMID: 11523072
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