Gnanasakthy A - Search Results

1

Efficacy and tolerability of vigabatrin in children with refractory partial seizures: a single-blind dose-increasing study.

Dalla Bernardina B, Fontana E, Vigevano F, Fusco L, Torelli D, Galeone D, Buti D, Cianchetti C, Gnanasakthy A, Iudice A. Dalla Bernardina B, et al. Among authors: gnanasakthy a. Epilepsia. 1995 Jul;36(7):687-91. doi: 10.1111/j.1528-1157.1995.tb01047.x. Epilepsia. 1995. PMID: 7555986 Clinical Trial.

2

Enoximone in chronic stable angina: a double-blind placebo-controlled cross-over trial.

Dubrey SW, Gnanasakthy A, Stein WK, Song JG, Hardman T, Hynd J, Noble MI. Dubrey SW, et al. Among authors: gnanasakthy a. J Cardiovasc Pharmacol. 1994 Apr;23(4):532-8. doi: 10.1097/00005344-199404000-00003. J Cardiovasc Pharmacol. 1994. PMID: 7516001 Clinical Trial.

3

The Limitations of EQ-5D as a Clinical Outcome Assessment Tool.

Gnanasakthy A, DeMuro CR. Gnanasakthy A, et al. Patient. 2024 May;17(3):215-217. doi: 10.1007/s40271-024-00683-w. Epub 2024 Mar 11. Patient. 2024. PMID: 38466537 No abstract available.

4

Critical Comments by Food and Drug Administration Reviewers on Patient-Reported Outcomes in Food and Drug Administration Regulatory Submissions (2018-2021).

Slota C, Norcross L, Comerford E, Sasane M, Zheng Y, Gnanasakthy A. Slota C, et al. Among authors: gnanasakthy a. Value Health. 2024 Mar 6:S1098-3015(24)00083-4. doi: 10.1016/j.jval.2024.02.011. Online ahead of print. Value Health. 2024. PMID: 38458563

5

Recommendations to address respondent burden associated with patient-reported outcome assessment.

Aiyegbusi OL, Cruz Rivera S, Roydhouse J, Kamudoni P, Alder Y, Anderson N, Baldwin RM, Bhatnagar V, Black J, Bottomley A, Brundage M, Cella D, Collis P, Davies EH, Denniston AK, Efficace F, Gardner A, Gnanasakthy A, Golub RM, Hughes SE, Jeyes F, Kern S, King-Kallimanis BL, Martin A, McMullan C, Mercieca-Bebber R, Monteiro J, Peipert JD, Quijano-Campos JC, Quinten C, Rantell KR, Regnault A, Sasseville M, Schougaard LMV, Sherafat-Kazemzadeh R, Snyder C, Stover AM, Verdi R, Wilson R, Calvert MJ. Aiyegbusi OL, et al. Among authors: gnanasakthy a. Nat Med. 2024 Mar;30(3):650-659. doi: 10.1038/s41591-024-02827-9. Epub 2024 Feb 29. Nat Med. 2024. PMID: 38424214 Review.

6

Assessment of Patient-Reported Outcomes in Industry-Sponsored Phase I Oncology Studies: Considerations for Translating Theory Into Practice.

Gnanasakthy A, Norcross L, Fitzgerald K. Gnanasakthy A, et al. Value Health. 2023 Oct;26(10):1440-1443. doi: 10.1016/j.jval.2023.06.006. Epub 2023 Jun 21. Value Health. 2023. PMID: 37353056

7

A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021).

Gnanasakthy A, Norcross L, Clark M, Fitzgerald K. Gnanasakthy A, et al. JCO Oncol Pract. 2023 May;19(5):e745-e762. doi: 10.1200/OP.22.00774. Epub 2023 Feb 28. JCO Oncol Pract. 2023. PMID: 36854073 Review.

8

A Review of Labeling Based on Patient-Reported Outcome Endpoints for New Oncology Drugs Approved by the European Medicines Agency (2017-2021).

Gnanasakthy A, Levy C, Norcross L, Doward L, Winnette R. Gnanasakthy A, et al. Value Health. 2023 Jun;26(6):893-901. doi: 10.1016/j.jval.2023.01.017. Epub 2023 Feb 4. Value Health. 2023. PMID: 36746305 Review.

9

Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results.

Forsythe E, Haws RM, Argente J, Beales P, Martos-Moreno GÁ, Dollfus H, Chirila C, Gnanasakthy A, Buckley BC, Mallya UG, Clément K, Haqq AM. Forsythe E, et al. Among authors: gnanasakthy a. Orphanet J Rare Dis. 2023 Jan 16;18(1):12. doi: 10.1186/s13023-022-02602-4. Orphanet J Rare Dis. 2023. PMID: 36647077 Free PMC article. Clinical Trial.

10

FDA Guidance on Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments: Old Wine in a New Bottle?

Gnanasakthy A, Qin S, Norcross L. Gnanasakthy A, et al. Patient. 2023 Jan;16(1):3-5. doi: 10.1007/s40271-022-00607-6. Epub 2022 Oct 19. Patient. 2023. PMID: 36260202 No abstract available.

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