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Items: 1 to 20 of 44

1.

Inhaled Corticosteroids and LABAs - Removal of the FDA's Boxed Warning.

Seymour SM, Lim R, Xia C, Andraca-Carrera E, Chowdhury BA.

N Engl J Med. 2018 Jun 28;378(26):2461-2463. doi: 10.1056/NEJMp1716858. No abstract available.

2.

The U.S. Food and Drug Administration's Experience with Ivacaftor in Cystic Fibrosis. Establishing Efficacy Using In Vitro Data in Lieu of a Clinical Trial.

Durmowicz AG, Lim R, Rogers H, Rosebraugh CJ, Chowdhury BA.

Ann Am Thorac Soc. 2018 Jan;15(1):1-2. doi: 10.1513/AnnalsATS.201708-668PS.

PMID:
29020455
3.

Exposure-Response Modeling and Power Analysis of Components of ACR Response Criteria in Rheumatoid Arthritis (Part 2: Continuous Model).

Li L, Zhang Y, Ma L, Ji P, Yim S, Chowdhury BA, Doddapaneni S, Liu J, Wang Y, Sahajwalla C.

J Clin Pharmacol. 2017 Sep;57(9):1107-1125. doi: 10.1002/jcph.967.

PMID:
28817201
4.

Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis.

Paterniti MO, Bi Y, Rekić D, Wang Y, Karimi-Shah BA, Chowdhury BA.

Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

PMID:
28388260
5.

Tiotropium Respimat Is Effective for the Treatment of Asthma at a Dose Lower Than That for Chronic Obstructive Pulmonary Disease.

Chin SJ, Durmowicz AG, Chowdhury BA.

Ann Am Thorac Soc. 2016 Feb;13(2):173-9. doi: 10.1513/AnnalsATS.201510-712PS.

PMID:
26650145
6.

Forced vital capacity in idiopathic pulmonary fibrosis--FDA review of pirfenidone and nintedanib.

Karimi-Shah BA, Chowdhury BA.

N Engl J Med. 2015 Mar 26;372(13):1189-91. doi: 10.1056/NEJMp1500526. No abstract available.

PMID:
25806913
7.

International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences.

Lu D, Lee SL, Lionberger RA, Choi S, Adams W, Caramenico HN, Chowdhury BA, Conner DP, Katial R, Limb S, Peters JR, Yu L, Seymour S, Li BV.

AAPS J. 2015 May;17(3):546-57. doi: 10.1208/s12248-015-9733-9. Epub 2015 Mar 11. Review.

8.

Response.

Durmowicz AG, Witzmann KA, Rosebraugh CJ, Chowdhury BA.

Chest. 2013 Oct;144(4):1418-1419. doi: 10.1378/chest.13-1517. No abstract available.

PMID:
24081359
9.

Change in sweat chloride as a clinical end point in cystic fibrosis clinical trials: the ivacaftor experience.

Durmowicz AG, Witzmann KA, Rosebraugh CJ, Chowdhury BA.

Chest. 2013 Jan;143(1):14-18. doi: 10.1378/chest.12-1430.

PMID:
23276841
10.

Dosing regimen determination for juvenile idiopathic arthritis: a review of studies during drug development.

Ji P, Chowdhury BA, Yim S, Sahajwalla CG.

J Pharm Sci. 2012 Aug;101(8):2621-34. doi: 10.1002/jps.23184. Epub 2012 May 31. Review.

PMID:
22653876
11.

Limitations of model based dose selection for indacaterol in patients with chronic obstructive pulmonary disease.

Wang Y, Lee JY, Michele T, Chowdhury BA, Gobburu JV.

Int J Clin Pharmacol Ther. 2012 Sep;50(9):622-30. doi: 10.5414/CP201758.

PMID:
22578206
12.

The risks and benefits of indacaterol--the FDA's review.

Chowdhury BA, Seymour SM, Michele TM, Durmowicz AG, Liu D, Rosebraugh CJ.

N Engl J Med. 2011 Dec 15;365(24):2247-9. doi: 10.1056/NEJMp1109621. No abstract available.

13.

Assessing the safety of adding LABAs to inhaled corticosteroids for treating asthma.

Chowdhury BA, Seymour SM, Levenson MS.

N Engl J Med. 2011 Jun 30;364(26):2473-5. doi: 10.1056/NEJMp1104375. No abstract available.

PMID:
21714647
14.

The FDA and safe use of long-acting beta-agonists in the treatment of asthma.

Chowdhury BA, Dal Pan G.

N Engl J Med. 2010 Apr 1;362(13):1169-71. doi: 10.1056/NEJMp1002074. Epub 2010 Feb 24. No abstract available.

15.

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.

Adams WP, Ahrens RC, Chen ML, Christopher D, Chowdhury BA, Conner DP, Dalby R, Fitzgerald K, Hendeles L, Hickey AJ, Hochhaus G, Laube BL, Lucas P, Lee SL, Lyapustina S, Li B, O'Connor D, Parikh N, Parkins DA, Peri P, Pitcairn GR, Riebe M, Roy P, Shah T, Singh GJ, Sharp SS, Suman JD, Weda M, Woodcock J, Yu L.

J Aerosol Med Pulm Drug Deliv. 2010 Feb;23(1):1-29. doi: 10.1089/jamp.2009.0803.

PMID:
20131983
16.

An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice.

Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations.

Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.

PMID:
19535666
17.

In vitro considerations to support bioequivalence of locally acting drugs in dry powder inhalers for lung diseases.

Lee SL, Adams WP, Li BV, Conner DP, Chowdhury BA, Yu LX.

AAPS J. 2009 Sep;11(3):414-23. doi: 10.1208/s12248-009-9121-4. Epub 2009 Jun 3. Review. Erratum in: AAPS J. 2011 Mar;13(1):141.

18.

Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma.

Limb SL, Starke PR, Lee CE, Chowdhury BA.

J Allergy Clin Immunol. 2007 Dec;120(6):1378-81. Epub 2007 Oct 22. Review. Erratum in: J Allergy Clin Immunol. 2008 Jan;121(1):178.

PMID:
17936893
19.

Immunotherapy with a ragweed vaccine.

Seymour SM, Chowdhury BA.

N Engl J Med. 2007 Jan 4;356(1):86; author reply 87. No abstract available.

PMID:
17202461
20.

Antibiotics and asthma treatment.

Chowdhury BA.

J Allergy Clin Immunol. 2007 Jan;119(1):251; author reply 251-2. Epub 2006 Sep 25. No abstract available.

PMID:
17137863

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