Reynolds K - Search Results

1

FDA Public Workshop Summary-Coccidioidomycosis (Valley Fever): Considerations for Development of Antifungal Drugs.

O'Shaughnessy E, Yasinskaya Y, Dixon C, Higgins K, Moore J, Reynolds K, Ampel NM, Angulo D, Blair JE, Catanzaro A, Galgiani JN, Garvey E, Johnson R, Larwood DJ, Lewis G, Purdie R, Rex JH, Shubitz LF, Stevens DA, Page SJ, Shukla SJ, Farley JJ, Nambiar S. O'Shaughnessy E, et al. Among authors: reynolds k. Clin Infect Dis. 2022 Jun 10;74(11):2061-2066. doi: 10.1093/cid/ciab904. Clin Infect Dis. 2022. PMID: 34651656

2

Connecting Hydroxychloroquine In Vitro Antiviral Activity to In Vivo Concentration for Prediction of Antiviral Effect: A Critical Step in Treating Patients With Coronavirus Disease 2019.

Fan J, Zhang X, Liu J, Yang Y, Zheng N, Liu Q, Bergman K, Reynolds K, Huang SM, Zhu H, Wang Y. Fan J, et al. Among authors: reynolds k. Clin Infect Dis. 2020 Dec 15;71(12):3232-3236. doi: 10.1093/cid/ciaa623. Clin Infect Dis. 2020. PMID: 32435791 Free PMC article.

3

A Regulatory Review Approach for Evaluation of Micafungin for Treatment of Neonatal Candidiasis.

Taormina G, Gopinath R, Moore J, Yasinskaya Y, Colangelo P, Reynolds K, Nambiar S. Taormina G, et al. Among authors: reynolds k. Clin Infect Dis. 2021 Dec 16;73(12):2335-2340. doi: 10.1093/cid/ciab025. Clin Infect Dis. 2021. PMID: 33458754

4

Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria.

Kitabi E, Bensman TJ, Earp JC, Chilukuri DM, Smith H, Ball L, O'Shaughnessy E, Yasinskaya Y, Colangelo PM, Reynolds KS. Kitabi E, et al. Clin Infect Dis. 2021 Sep 7;73(5):903-906. doi: 10.1093/cid/ciab149. Clin Infect Dis. 2021. PMID: 33605994

5

Reply to White et al.

Kitabi E, Bensman TJ, Earp JC, Chilukuri DM, Smith H, Ball L, O'Shaughnessy E, Yasinskaya Y, Reynolds KS. Kitabi E, et al. Clin Infect Dis. 2022 Aug 25;75(2):359. doi: 10.1093/cid/ciac025. Clin Infect Dis. 2022. PMID: 35023546 No abstract available.

6

Cefiderocol Dosing for Patients Receiving Continuous Renal Replacement Therapy.

Wei X, Naseer S, Weinstein EA, Iarikov D, Nambiar S, Reynolds KS, Jang SH. Wei X, et al. Clin Pharmacol Ther. 2022 Nov;112(5):1004-1007. doi: 10.1002/cpt.2703. Epub 2022 Jul 21. Clin Pharmacol Ther. 2022. PMID: 35792715

7

FDA evaluations using in vitro metabolism to predict and interpret in vivo metabolic drug-drug interactions: impact on labeling.

Davit B, Reynolds K, Yuan R, Ajayi F, Conner D, Fadiran E, Gillespie B, Sahajwalla C, Huang SM, Lesko LJ. Davit B, et al. Among authors: reynolds k. J Clin Pharmacol. 1999 Sep;39(9):899-910. doi: 10.1177/00912709922008515. J Clin Pharmacol. 1999. PMID: 10471980

8

Are literature references sufficient for dose recommendations? An FDA case study of efavirenz and rifampin.

DiGiacinto JL, Chan-Tack KM, Robertson SM, Reynolds KS, Struble KA. DiGiacinto JL, et al. J Clin Pharmacol. 2008 Apr;48(4):518-23. doi: 10.1177/0091270008315308. Epub 2008 Feb 26. J Clin Pharmacol. 2008. PMID: 18303126 Review.

9

Transporters in Drug Development: Scientific and Regulatory Considerations.

Zhang L, Huang SM, Reynolds K, Madabushi R, Zineh I. Zhang L, et al. Among authors: reynolds k. Clin Pharmacol Ther. 2018 Nov;104(5):793-796. doi: 10.1002/cpt.1214. Epub 2018 Sep 30. Clin Pharmacol Ther. 2018. PMID: 30270426

10

Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.

Sahre MD, Milligan L, Madabushi R, Graham RA, Reynolds KS, Terzic A, Benjamin J, Burckart GJ, Huang SM, Schuck R, Thompson AM, Zineh I. Sahre MD, et al. Clin Pharmacol Ther. 2021 Aug;110(2):285-288. doi: 10.1002/cpt.2151. Epub 2021 Feb 16. Clin Pharmacol Ther. 2021. PMID: 33411946

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