title: Toward an Evidence-Based Nonclinical Road Map for Evaluating the Efficacy of New Tuberculosis (TB) Drug Regimens: Proceedings of a Critical Path to TB Drug Regimens-National Institute of Allergy and Infectious Diseases In Vivo Pharmacology Workshop for TB Drug Development.
abstract: Novel tuberculosis (TB) drug regimens are urgently needed, and their development will be enabled by improved preclinical approaches that more effectively inform and ensure safe selection of clinical candidates and drug combination/regimens. An evidence-based approach for the assessment of nonclinical models supporting TB drug development has been proposed by a joint partnership between the National Institute of Allergy and Infectious Diseases (NIAID) and the Critical Path to TB Drug Regimens (CPTR) Consortium.
authors.affiliation: Center for Tuberculosis Research, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Nuermberger
authors.affiliation: National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Sizemore
authors.affiliation: Critical Path Institute, Tucson, Arizona, USA.
authors.forename: Klaus
authors.initials: K
authors.lastname: Romero
authors.affiliation: Critical Path Institute, Tucson, Arizona, USA dhanna@c-path.org.
authors.forename: Debra
authors.initials: D
authors.lastname: Hanna
mesh_terms: D000818:Animals; D000995:Antitubercular Agents / Q000494:pharmacology*; D017322:Clinical Trials, Phase II as Topic; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D004359:Drug Therapy, Combination; D019317:Evidence-Based Medicine / Q000379:methods; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000187:drug effects; D054579:National Institute of Allergy and Infectious Diseases (U.S.); D014376:Tuberculosis / Q000188:drug therapy* / Q000382:microbiology; D014481:United States
chemical_list: D000995:Antitubercular Agents
references.citation: Dis Model Mech. 2015 Jun;8(6):603-10
references.pmid: 26035868
references.citation: J Infect Dis. 2015 Jun 15;211 Suppl 3:S96-S106
references.pmid: 26009618
references.citation: Clin Infect Dis. 2015 Aug 15;61 Suppl 1:S18-24
references.pmid: 26224768
references.citation: Clin Infect Dis. 2015 Aug 15;61 Suppl 1:S25-31
references.pmid: 26224769
references.citation: MBio. 2015;6(6):e01741-15
references.pmid: 26530386
references.citation: Am J Respir Crit Care Med. 2010 Jan 15;181(2):174-80
references.pmid: 19875686
references.citation: J Antimicrob Chemother. 2010 Apr;65(4):729-34
references.pmid: 20123722
references.citation: MBio. 2010;1(3). pii: e00139-10. doi: 10.1128/mBio.00139-10
references.pmid: 20802826
references.citation: Antimicrob Agents Chemother. 2012 Jun;56(6):3181-95
references.pmid: 22470120
references.citation: J Antimicrob Chemother. 2012 Aug;67(8):1948-60
references.pmid: 22635525
references.citation: Infect Immun. 2013 Aug;81(8):2909-19
references.pmid: 23716617
references.citation: Nat Rev Microbiol. 2014 Mar;12(3):159-67
references.pmid: 24487820
references.citation: PLoS One. 2014;9(7):e101311
references.pmid: 25003557
references.citation: J Infect Dis. 2015 Jun 15;211 Suppl 3:S83-95
references.pmid: 26009617
references.citation: Clin Infect Dis. 2015 Aug 15;61 Suppl 1:S10-7
references.pmid: 26224767