Generating Robust and Informative Nonclinical

best practices drug development hollow fiber system in vitro infection models mouse infection models optimal design pharmacokinetics/pharmacodynamics progression and decision criteria validation workshop summary

Journal

Antimicrobial agents and chemotherapy
ISSN: 1098-6596
Titre abrégé: Antimicrob Agents Chemother
Pays: United States
ID NLM: 0315061

Informations de publication

Date de publication:
05 2019
Historique:
pubmed: 6 3 2019
medline: 31 3 2020
entrez: 6 3 2019
Statut: epublish

Résumé

In June 2017, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, organized a workshop entitled "Pharmacokinetics-Pharmacodynamics (PK/PD) for Development of Therapeutics against Bacterial Pathogens." The aims were to discuss details of various PK/PD models and identify sound practices for deriving and utilizing PK/PD relationships to design optimal dosage regimens for patients. Workshop participants encompassed individuals from academia, industry, and government, including the United States Food and Drug Administration. This and the accompanying review on clinical PK/PD summarize the workshop discussions and recommendations. Nonclinical PK/PD models play a critical role in designing human dosage regimens and are essential tools for drug development. These include

Identifiants

pubmed: 30833428
pii: AAC.02307-18
doi: 10.1128/AAC.02307-18
pmc: PMC6496039
pii:
doi:

Substances chimiques

Anti-Bacterial Agents 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2019 Bulitta et al.

Références

Antimicrob Agents Chemother. 2018 Mar 27;62(4):
pubmed: 29339388
J Pharmacokinet Biopharm. 1981 Oct;9(5):635-51
pubmed: 7334463
J Pharmacokinet Pharmacodyn. 2005 Aug;32(3-4):441-57
pubmed: 16284917
Antimicrob Agents Chemother. 2018 May 25;62(6):
pubmed: 29581114
J Pharm Sci. 1998 Oct;87(10):1177-83
pubmed: 9758673
Antimicrob Agents Chemother. 2012 Jul;56(7):3712-9
pubmed: 22526313
J Antimicrob Chemother. 2012 Sep;67(9):2182-90
pubmed: 22685161
Antimicrob Agents Chemother. 2010 Sep;54(9):3783-9
pubmed: 20585118
Pharm Stat. 2009 Jul-Sep;8(3):239-52
pubmed: 19009585
Antimicrob Agents Chemother. 2009 Jun;53(6):2266-73
pubmed: 19289521
Antimicrob Agents Chemother. 1997 Apr;41(4):733-8
pubmed: 9087479
Antimicrob Agents Chemother. 2009 May;53(5):2074-81
pubmed: 19223648
AAPS J. 2011 Jun;13(2):201-11
pubmed: 21369876
J Infect Dis. 2007 Jun 15;195(12):1818-27
pubmed: 17492598
Anal Bioanal Chem. 2010 Sep;398(1):53-66
pubmed: 20454782
PLoS One. 2014 Jul 08;9(7):e101311
pubmed: 25003557
Antimicrob Agents Chemother. 1988 Nov;32(11):1705-9
pubmed: 3252752
Antimicrob Agents Chemother. 2014;58(4):2113-8
pubmed: 24468780
Antimicrob Agents Chemother. 2018 Aug 27;62(9):
pubmed: 29967017
Antimicrob Agents Chemother. 2011 Dec;55(12):5685-95
pubmed: 21911563
Annu Rev Pharmacol Toxicol. 2008;48:303-32
pubmed: 17914927
J Infect Dis. 2014 Oct 15;210(8):1319-24
pubmed: 24760199
J Antimicrob Chemother. 2016 May;71(5):1279-90
pubmed: 26850719
Antimicrob Agents Chemother. 2016 Mar 25;60(4):2075-80
pubmed: 26787689
Antimicrob Agents Chemother. 2005 Mar;49(3):908-15
pubmed: 15728883
Antimicrob Agents Chemother. 1996 Nov;40(11):2478-82
pubmed: 8913449
Antimicrob Agents Chemother. 2019 Apr 25;63(5):
pubmed: 30833427
Paediatr Anaesth. 2015 Mar;25(3):222-30
pubmed: 25580772
Antimicrob Agents Chemother. 2018 Mar 27;62(4):
pubmed: 29437610
J Antimicrob Chemother. 2013 May;68(5):1130-8
pubmed: 23361641
J Infect Dis. 1982 Nov;146(5):691-7
pubmed: 6813385
Clin Infect Dis. 2007 Sep 15;45(6):753-60
pubmed: 17712761
Antimicrob Agents Chemother. 2015 Dec 07;60(2):1029-34
pubmed: 26643340
Nat Rev Microbiol. 2004 Apr;2(4):289-300
pubmed: 15031728
Clin Pharmacokinet. 2009;48(2):89-124
pubmed: 19271782
J Pharmacokinet Biopharm. 1988 Jun;16(3):303-9
pubmed: 3221328
Antimicrob Agents Chemother. 2009 Dec;53(12):5181-4
pubmed: 19805569
Antimicrob Agents Chemother. 2015 Apr;59(4):2315-27
pubmed: 25645838
Antimicrob Agents Chemother. 2010 May;54(5):2051-62
pubmed: 20211900
Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S103-10
pubmed: 20597657
Antimicrob Agents Chemother. 2009 Sep;53(9):3894-901
pubmed: 19596879
Expert Rev Anti Infect Ther. 2017 Jun;15(6):519-526
pubmed: 28375030
Antimicrob Agents Chemother. 2013 Dec;57(12):5924-30
pubmed: 24041895
Antimicrob Agents Chemother. 2011 Jun;55(6):2693-5
pubmed: 21422203
J Clin Invest. 2003 Jul;112(2):275-85
pubmed: 12865415
mBio. 2010 Aug 10;1(3):
pubmed: 20802826
Antimicrob Agents Chemother. 2012 Jan;56(1):179-88
pubmed: 22037853
J Biopharm Stat. 2005;15(1):53-73
pubmed: 15702605
Antimicrob Agents Chemother. 2015 Dec 28;60(3):1600-7
pubmed: 26711755
Antimicrob Agents Chemother. 2001 Jan;45(1):13-22
pubmed: 11120938
J Pharmacokinet Pharmacodyn. 2007 Dec;34(6):727-51
pubmed: 17906920
J Clin Pharmacol. 1994 Oct;34(10):967-74
pubmed: 7836547
Antimicrob Agents Chemother. 2012 May;56(5):2237-40
pubmed: 22330927
Antimicrob Agents Chemother. 2018 May 25;62(6):
pubmed: 29712652
PLoS Biol. 2010 Jun 29;8(6):e1000412
pubmed: 20613859
J Antimicrob Chemother. 2015 May;70(5):1434-42
pubmed: 25712313
J Antimicrob Chemother. 2010 Feb;65(2):186-201
pubmed: 20026612
AAPS J. 2007 Mar 02;9(1):E60-83
pubmed: 17408237
Antimicrob Agents Chemother. 2008 Oct;52(10):3694-700
pubmed: 18644952
Clin Infect Dis. 2007 Jan 1;44(1):79-86
pubmed: 17143821
Antimicrob Agents Chemother. 2006 Jun;50(6):1953-8
pubmed: 16723551
J Infect Dis. 1990 Apr;161(4):755-60
pubmed: 2138654
J Pharm Sci. 1998 Mar;87(3):372-8
pubmed: 9523992
Antimicrob Agents Chemother. 2011 Jul;55(7):3406-12
pubmed: 21576431
Antimicrob Agents Chemother. 2012 Jan;56(1):258-70
pubmed: 22024819
Infect Immun. 1974 Dec;10(6):1256-9
pubmed: 4611923
J Antimicrob Chemother. 2016 May;71(5):1270-8
pubmed: 26846209
Antimicrob Agents Chemother. 2009 Jan;53(1):46-56
pubmed: 18852268
J Pharm Sci. 2008 Sep;97(9):4108-17
pubmed: 18314887
Antimicrob Agents Chemother. 1978 Apr;13(4):570-6
pubmed: 352258
Antimicrob Agents Chemother. 2017 Aug 24;61(9):
pubmed: 28630178
Antimicrob Agents Chemother. 2006 Sep;50(9):2946-50
pubmed: 16940086
J Infect Dis. 2009 Jan 15;199(2):219-26
pubmed: 19049435
Antimicrob Agents Chemother. 2017 Oct 24;61(11):
pubmed: 28807913
Antimicrob Agents Chemother. 1992 Jul;36(7):1427-31
pubmed: 1510438
Antimicrob Agents Chemother. 2007 Feb;51(2):744-7
pubmed: 17116679
Antimicrob Agents Chemother. 2017 Nov 22;61(12):
pubmed: 28893782
Antimicrob Agents Chemother. 2011 Sep;55(9):4277-82
pubmed: 21670191
Antimicrob Agents Chemother. 2016 Jun 20;60(7):3921-33
pubmed: 27067324
Int J Antimicrob Agents. 2016 Dec;48(6):719-724
pubmed: 27773498
Antimicrob Agents Chemother. 2009 Aug;53(8):3294-301
pubmed: 19451287
Antimicrob Agents Chemother. 2016 Dec 27;61(1):
pubmed: 27821448
Antimicrob Agents Chemother. 2015 Apr;59(4):2286-98
pubmed: 25645842
Antimicrob Agents Chemother. 2005 Dec;49(12):5099-106
pubmed: 16304178
Curr Opin Pharmacol. 2017 Oct;36:94-99
pubmed: 28964956
Antimicrob Agents Chemother. 2017 Dec 21;62(1):
pubmed: 29038277
Antimicrob Agents Chemother. 1994 Jun;38(6):1386-91
pubmed: 8092842
Antimicrob Agents Chemother. 2008 Jul;52(7):2486-96
pubmed: 18458134
Scand J Infect Dis Suppl. 1990;74:63-70
pubmed: 2097720
AAPS J. 2011 Jun;13(2):212-26
pubmed: 21374103
AAPS J. 2016 Sep;18(5):1233-1243
pubmed: 27306546
J Pharm Sci. 2018 Feb;107(2):739-744
pubmed: 28927988
Antimicrob Agents Chemother. 2010 Nov;54(11):4879-86
pubmed: 20713673
Antimicrob Agents Chemother. 2011 Nov;55(11):5300-5
pubmed: 21911576
Diagn Microbiol Infect Dis. 2011 May;70(1):101-11
pubmed: 21513848
J Pharmacokinet Biopharm. 1980 Dec;8(6):553-71
pubmed: 7229908
Antimicrob Agents Chemother. 2012 Jan;56(1):231-42
pubmed: 22005996
Clin Pharmacokinet. 2011 Oct;50(10):637-64
pubmed: 21895037
J Infect Dis. 2004 Nov 1;190(9):1642-51
pubmed: 15478070
Antimicrob Agents Chemother. 2018 Nov 26;62(12):
pubmed: 30249700
Antimicrob Agents Chemother. 2010 Jun;54(6):2646-54
pubmed: 20368395
J Antimicrob Chemother. 2016 Nov;71(11):3157-3167
pubmed: 27521357
Antimicrob Agents Chemother. 2018 Nov 26;62(12):
pubmed: 30249693
Antimicrob Agents Chemother. 2004 Jun;48(6):2061-8
pubmed: 15155200
Antimicrob Agents Chemother. 2011 Apr;55(4):1606-10
pubmed: 21300830
Antimicrob Agents Chemother. 2013 May;57(5):2343-51
pubmed: 23478962
Pharm Res. 1995 Jan;12(1):124-8
pubmed: 7724473
Clin Pharmacokinet. 2008;47(6):373-81
pubmed: 18479172
J Antimicrob Chemother. 1985 Jan;15 Suppl A:125-30
pubmed: 3980323
Antimicrob Agents Chemother. 2002 Feb;46(2):586-9
pubmed: 11796385
Antimicrob Agents Chemother. 2015 Jan;59(1):381-8
pubmed: 25367905
Clin Infect Dis. 1998 Jan;26(1):1-10; quiz 11-2
pubmed: 9455502
Antimicrob Agents Chemother. 2010 Oct;54(10):4368-72
pubmed: 20516275
Clin Microbiol Rev. 2010 Oct;23(4):858-83
pubmed: 20930076
J Antimicrob Chemother. 2017 Jan;72(1):153-165
pubmed: 27634916
Antimicrob Agents Chemother. 2014;58(4):2334-43
pubmed: 24514086
Clin Infect Dis. 2012 Apr;54 Suppl 3:S220-8
pubmed: 22431852
Antimicrob Agents Chemother. 2005 Jan;49(1):209-19
pubmed: 15616298
Rev Infect Dis. 1979 Mar-Apr;1(2):291-301
pubmed: 232936
Antimicrob Agents Chemother. 2007 Jul;51(7):2621-4
pubmed: 17470659
mBio. 2015 Nov 03;6(6):e01741-15
pubmed: 26530386
Antimicrob Agents Chemother. 2005 Jul;49(7):2735-45
pubmed: 15980344
J Med Chem. 2008 May 22;51(10):2871-8
pubmed: 18260614
Antimicrob Agents Chemother. 2013 Jan;57(1):508-16
pubmed: 23147722
Antimicrob Agents Chemother. 2012 Feb;56(2):708-14
pubmed: 22123680
Antimicrob Agents Chemother. 2008 Jun;52(6):1945-51
pubmed: 17485507
Clin Infect Dis. 2011 Jun;52 Suppl 7:S513-9
pubmed: 21546628
Prog Drug Res. 1987;31:349-81
pubmed: 3326034
Curr Pharm Biotechnol. 2011 Dec;12(12):2044-61
pubmed: 21554212
Eur J Pharm Sci. 2012 Jan 23;45(1-2):90-100
pubmed: 22094306
Antimicrob Agents Chemother. 2002 Aug;46(8):2327-32
pubmed: 12121900
Clin Pharmacol Ther. 1988 Aug;44(2):232-8
pubmed: 3293877
J Lab Clin Med. 1982 Nov;100(5):671-81
pubmed: 6813409
Antimicrob Agents Chemother. 2015 Oct 19;60(1):180-9
pubmed: 26482300
Clin Pharmacol Ther. 2010 Aug;88(2):166-82
pubmed: 20613720
Antimicrob Agents Chemother. 2013 Jan;57(1):498-507
pubmed: 23147726
Antimicrob Agents Chemother. 2007 Aug;51(8):2661-7
pubmed: 17517837
Int J Antimicrob Agents. 2002 Apr;19(4):261-8
pubmed: 11978497
J Antimicrob Chemother. 2013 May;68(5):1104-10
pubmed: 23341128
J Antimicrob Chemother. 1995 Jan;35(1):149-54
pubmed: 7768762
Stat Med. 1995 May 15-30;14(9-10):1009-24
pubmed: 7569497
Antimicrob Agents Chemother. 2009 Aug;53(8):3325-30
pubmed: 19364849
Clin Pharmacol Ther. 1989 Jun;45(6):635-41
pubmed: 2659235
Antimicrob Agents Chemother. 2013 Mar;57(3):1434-41
pubmed: 23295932

Auteurs

Jürgen B Bulitta (JB)

Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA jbulitta@cop.ufl.edu Jennifer.L.Hoover@gsk.com.

William W Hope (WW)

Centre for Antimicrobial Pharmacodynamics, Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.

Ann E Eakin (AE)

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.

Tina Guina (T)

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.

Vincent H Tam (VH)

College of Pharmacy, University of Houston, Houston, Texas, USA.

Arnold Louie (A)

Institute for Therapeutic Innovation and Department of Medicine, College of Medicine, University of Florida, Orlando, Florida, USA.

George L Drusano (GL)

Institute for Therapeutic Innovation and Department of Medicine, College of Medicine, University of Florida, Orlando, Florida, USA.

Jennifer L Hoover (JL)

Antibacterial Discovery Performance Unit, GlaxoSmithKline, Collegeville, Pennsylvania, USA jbulitta@cop.ufl.edu Jennifer.L.Hoover@gsk.com.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH