Research Papers

This database includes peer-reviewed publications authored by TB Alliance staff. Use the tags on the left to filter by subject, or search for a particular author or term using the search bar.

Tag: Clinical Development

Displaying 48 papers

Multidrug-resistant tuberculosis

Publication: D'Ambrosio L, Centis R, Migliori GB. Multidrug-resistant tuberculosis. N Engl J Med. 2012 Nov 29;367(22):2154; author reply 2155-6. doi: 10.1056/NEJMc1210001#SA1.

11/2012

Tags: Advocacy, Clinical Development, Editorials, Trial Design

Moxifloxacin for tuberculosis

Publication: Mendel C, Springsklee M. Moxifloxacin for tuberculosis. Lancet Infect Dis. 2012 Mar;12(3):176-7; author reply 177-8. doi: 10.1016/S1473-3099(11)70351-6.

3/2012

Tags: Advocacy, Clinical Development, Drug-Sensitivity Testing, Editorials, MDR-TB, Moxifloxacin, Policy, Regimen Change

New Drugs for the Treatment of Tuberculosis: Needs, Challenges, Promise, and Prospects for the Future

Publication: Lienhardt C, Raviglione M, Spigelman M, et. al. New drugs for the treatment of tuberculosis: needs, challenges, promise, and prospects for the future. J Infect Dis. 2012 May 15;205 Suppl 2:S241-9. doi: 10.1093/infdis/jis034.

3/2012

Tags: Advocacy, Childhood TB, Clinical Development, Drug Discovery, Drug-Sensitivity Testing, Editorials, Global Pipeline, MDR-TB, Moxifloxacin, Pharmacodynamics, Pharmacokinetics, Policy, Preclinical Models, Pretomanid/PA-824, Regimen Change, TB Market, TB-HIV, Trial Design

Phase II dose-ranging trial of the early bactericidal activity of PA-824

Publication: Diacon AH, Dawson R, du Bois J, et. al. Phase II dose-ranging trial of the early bactericidal activity of PA-824. Antimicrob Agents Chemother. 2012 Jun;56(6):3027-31. doi: 10.1128/AAC.06125-11

3/2012

Tags: Clinical Development, Clinical Trial Results, Pharmacokinetics, Pretomanid/PA-824

Drugs for neglected diseases: part II

Publication: Kaneko T. Drugs for neglected diseases: part II. Future Med Chem. 2011 Sep;3(11):1329-30. doi: 10.4155/fmc.11.104.

9/2011

Tags: Advocacy, Clinical Development, Drug Discovery, Editorials, Global Pipeline, TB Burden

14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial.

Publication: Diacon AH, Dawson R, von Groote-Bidlingmaier F, et. al. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. Lancet. 2012 Sep 15;380(9846):986-93. doi: 10.1016/S0140-6736(12)61080-0.

9/2011

Tags: Bedaquiline (TMC-207), Clinical Development, Clinical Trial Results, MDR-TB, Moxifloxacin, NC-001, PaMZ, Pretomanid/PA-824, Pyrazinamide

Drugs for neglected diseases: part I

Publication: Kaneko T. Drugs for neglected diseases: part I. Future Med Chem. 2011 Aug;3(10):1235-7. doi: 10.4155/fmc.11.103.

8/2011

Tags: Advocacy, Clinical Development, Drug Discovery, Editorials, Global Pipeline, TB Burden, TB-HIV

Drugs in development for tuberculosis

Publication: Ginsberg AM, Drugs in development for tuberculosis. Drugs. 2010 Dec 3;70(17):2201-14. doi: 10.2165/11538170-000000000-00000.

12/2010

Tags: Advocacy, Bedaquiline (TMC-207), Clinical Development, Editorials, Global Pipeline, Pretomanid/PA-824, Rifapentine, TB Burden

Current development and future prospects in chemotherapy of tuberculosis

Publication: Nuermberger EL, Spigelman MK, Yew WW. Current development and future prospects in chemotherapy of tuberculosis. Respirology. 2010 Jul;15(5):764-78. doi: 10.1111/j.1440-1843.2010.01775.x.

7/2010

Tags: Bedaquiline (TMC-207), Clinical Development, Drug Discovery, Editorials, Global Pipeline, Moxifloxacin, Pretomanid/PA-824, TB Market

New initiative speeds tuberculosis drug development: novel drug regimens become possible in years, not decades

Publication: Spigelman M, Woosley R, Gheuens J. New initiative speeds tuberculosis drug development: novel drug regimens become possible in years, not decades. Int J Tuberc Lung Dis. 2010 Jun;14(6):663-4. http://www.ingentaconnect.com/content/iuatld/ijtld/2010/0000001

6/2010

Tags: Advocacy, Clinical Development, Editorials, MDR-TB, TB Drug Market, TB Market, Trial Design

Global tuberculosis drug development pipeline: the need and the reality

Publication: Ma Z, Lienhardt C, McIlleron H, Nunn AJ, Wang X. Global tuberculosis drug development pipeline: the need and the reality. Lancet. 2010 Jun 12;375(9731):2100-9. doi: 10.1016/S0140-6736(10)60359-9.

5/2010

Tags: Advocacy, Bedaquiline (TMC-207), Biomarkers, Childhood TB, Clinical Development, Editorials, Global Pipeline, MDR-TB, Moxifloxacin, Policy, Pretomanid/PA-824, Rifapentine, Sutezolid, Trial Design

Early Bactericidal Activity and Pharmacokinetics of PA-824 in Smear-Positive Tuberculosis Patients (AAC01354-09)

Publication: Diacon AH, Dawson R, Hanekom M, et. al. Early bactericidal activity and pharmacokinetics of PA-824 in smear-positive tuberculosis patients. Antimicrob Agents Chemother. 2010 Aug;54(8):3402-7. doi: 10.1128/AAC.01354-09.

5/2010

Tags: Clinical Development, Clinical Trial Results, Moxifloxacin, NC-001, PaMZ, Pretomanid/PA-824, Pyrazinamide

Tuberculosis drug development: Progress, challenges, and the road ahead

Publication: Ginsberg AM. Tuberculosis drug development: progress, challenges, and the road ahead. Tuberculosis (Edinb). 2010 May;90(3):162-7. doi: 10.1016/j.tube.2010.03.003.

4/2010

Tags: Advocacy, Clinical Development, Editorials, Global Pipeline, MDR-TB, Policy

Toward an Optimized Therapy for Tuberculosis? Drugs in Clinical Trials and in Preclinical Development

Publication: Ma Z, Lienhardt C. Toward an optimized therapy for tuberculosis? Drugs in clinical trials and in preclinical development. Clin Chest Med. 2009 Dec;30(4):755-68, ix. doi: 10.1016/j.ccm.2009.08.011.

12/2009

Tags: Advocacy, Clinical Development, Drug Discovery, Editorials, Global Pipeline, MDR-TB, TB-HIV

Assessment of global capacity to conduct tuberculosis drug development trials- do we have what it takes

Publication: van Niekerk C, Ginsberg A. Assessment of global capacity to conduct tuberculosis drug development trials: do we have what it takes? Int J Tuberc Lung Dis. 2009 Nov;13(11):1367-72. http://www.ingentaconnect.com/content/iuatld/ijtld/2009/00000013/00000011/a

11/2009

Tags: Advocacy, Clinical Development, Policy

Assessment of the Effects of the Nitroimidazo-Oxazine PA-824 on

Publication: Ginsberg AM, Laurenzi MW, Rouse DJ, Whitney KD, Spigelman MK. Assessment of the effects of the nitroimidazo-oxazine PA-824 on renal function in healthy subjects. Antimicrob Agents Chemother. 2009 Sep;53(9):3726-33. doi: 10.1128/AAC.00112-09

6/2009

Tags: Advocacy, Clinical Development, Clinical Trial Results, Pretomanid/PA-824

Safety, Tolerability, and Pharmacokinetics of PA-824 in Healthy Subjects

Publication: Ginsberg AM, Laurenzi MW, Rouse DJ, Whitney KD, Spigelman, MK. Safety, tolerability, and pharmacokinetics of PA-824 in healthy subjects. Antimicrob Agents Chemother. 2009 Sep;53(9):3720-5. doi: 10.1128/AAC.00106-09.

6/2009

Tags: Clinical Development, Clinical Trial Results, Pharmacodynamics, Pretomanid/PA-824

Emerging Drugs for Active Tuberculosis

Publication: Ginsberg AM. Emerging drugs for active tuberculosis. Semin Respir Crit Care Med. 2008 Oct;29(5):552-9. doi: 10.1055/s-0028-1085706.

10/2008

Tags: Bedaquiline (TMC-207), Clinical Development, Drug Discovery, Editorials, Global Pipeline, Pretomanid/PA-824, Rifapentine

Handbook of anti-tuberculosis agents

Publication: Handbook of Anti-Tuberculosis Agents. Tuberculosis (Edinb). 2008 Mar;88(2):85-6. doi: 10.1016/S1472-9792(08)70002-7.

3/2008

Tags: Clinical Development, Clofazamine, Global Pipeline, HRZE, Linezolid, Moxifloxacin, Pharmacodynamics, Pharmacokinetics, Pyrazinamide, Rifapentine, Sutezolid

The ethics of non-inferiority trials

Publication: Nunn AJ, Meredith SK, Spigelman MK, Ginsberg AM, Gillespie SH. The ethics of non-inferiority trials. Lancet. 2008 Mar 15;371(9616):895; author reply 896-7. doi: 10.1016/S0140-6736(08)60404-3.

3/2008

Tags: Advocacy, Clinical Development, Clinical Trial Results, Editorials, Policy, Trial Design

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