Zobrazeno 1 - 10
of 20
pro vyhledávání: '"Gordon W. Pledger"'
Autor:
Qing Liu, Gordon W Pledger
Publikováno v:
Journal of the American Statistical Association. 100:493-502
For late-stage clinical development, we propose combining phase 2 and 3 trials via a two-stage adaptive design. In the first stage, short-term safety and efficacy are examined, after which low doses that lack efficacy and high doses that cause safety
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a3486a86667e689911a2c2bb0c41eac
http://www.ingentaconnect.com/content/asa/jasa/2005/00000100/00000470/art00012
http://www.ingentaconnect.com/content/asa/jasa/2005/00000100/00000470/art00012
Publikováno v:
Sequential Analysis. 23:317-331
Under a group sequential design, the conditional power at an interim analysis represents the probability of success in the future given the past data. Because an adequate overall power is not a guarantee of an adequate conditional power, many authors
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::062bd090c0aa4b3d808cbfc6324e9f7d
https://doi.org/10.1081/sqa-200027049
https://doi.org/10.1081/sqa-200027049
Publikováno v:
Epilepsia. 41:440-446
Summary: Purpose: There is controversy between clinicians and statisticians on the appropriateness of the number needed to treat (NNT) as a summary statistic to report the effectiveness of a treatment. We examine the two viewpoints and make proposals
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::db3837217c211317cdf8f7c9713a896d
https://doi.org/10.1111/j.1528-1157.2000.tb00186.x
https://doi.org/10.1111/j.1528-1157.2000.tb00186.x
Publikováno v:
Epilepsia. 38:294-300
Purpose: Evaluation of topiramate (TPM) as monotherapy in patients with uncontrolled partial onset seizures. Methods: A total of 48 patients were evaluated in a double-blind, parallel-group trial. During a 56-day baseline period, patients had at leas
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bbcd79eee8cd701f6440638890b66171
https://doi.org/10.1111/j.1528-1157.1997.tb01120.x
https://doi.org/10.1111/j.1528-1157.1997.tb01120.x
Autor:
R. Fincham, Rezaul Karim, Michael Privitera, Gordon W. Pledger, Lynn D. Kramer, R. Reife, J. Penry
Publikováno v:
Neurology. 46:1678-1683
We conducted a multicenter, double-blind, randomized, parallel, placebo-controlled trial in 190 patients to evaluate the safety and efficacy of three dosages of topiramate (600, 800, and 1,000 mg/day) as adjunctive therapy for patients with refractor
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0d9ae9f3a14375221425ab9b0c43a797
https://doi.org/10.1212/wnl.46.6.1678
https://doi.org/10.1212/wnl.46.6.1678
Publikováno v:
Epilepsia. 34:1075-1084
Antiepileptic drug (AED) development has been generally difficult owing to many factors: regulatory requirements for demonstration of efficacy and safety, subject availability, traditional trial designs, and physicians' beliefs about epilepsy and its
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::73f241457af1033959c20a0fcd9b6521
https://doi.org/10.1111/j.1528-1157.1993.tb02136.x
https://doi.org/10.1111/j.1528-1157.1993.tb02136.x
Autor:
Gordon W. Pledger, David M. Treiman
Publikováno v:
Controlled Clinical Trials. 12:768-779
Flunerizine (FLN) is a potential antiepileptic drug whose pharmacokinetic properties include a long half-life (2–7 weeks) and high interpatient variability in volume of distribution and clearance. The National Institutes of Health (NIH) is sponsori
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7626c43b2b117f2b8a0d1eadefea5537
https://doi.org/10.1016/0197-2456(91)90040-s
https://doi.org/10.1016/0197-2456(91)90040-s
Publikováno v:
Epilepsia. 41(S1)
Summary: Purpose: Six double-blind, placebo-controlled trials were conducted with topiramate (TPM) initiated as adjunctive therapy in adults with treatment-resistant partial-onset seizures with or without secondary generalization. Methods: Because pr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b76409fd2dd966e2720f1e3b9c7990f
https://pubmed.ncbi.nlm.nih.gov/10768304
https://pubmed.ncbi.nlm.nih.gov/10768304
Autor:
M. Weber, R. Reife, Elinor Ben-Menachem, C. Viteri, Gordon W. Pledger, M. Sharief, Rezaul Karim
Publikováno v:
Epilepsy research. 25(3)
The efficacy and safety of topiramate 400 mg/day as adjunctive therapy to traditional antieleptic drugs for partial onset seizures with or without secondary generalization were assessed in a double-blind, parallel-group, placebo-controlled trial. For
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f550a45c153276a037023c5e892518bf
https://pubmed.ncbi.nlm.nih.gov/8956919
https://pubmed.ncbi.nlm.nih.gov/8956919
Autor:
Simon Shorvon, Patrick Chauvel, J. Chodkiewicz, Gordon W. Pledger, Olaf Henriksen, Rezaul Karim, Carlo Alberto Tassinari, Mogens Dam, Roberto Michelucci, R. Reife
Publikováno v:
Scopus-Elsevier
Purpose: We wished to evaluate adjunctive therapy for partial-onset seizures with topiramate (TPM) for efficacy and safety in a double-blind, placebo-controlled, randomized, parallel-group study.Methods: Sixty outpatients with epilepsy (47 men and 13
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3717480c3c16c7816f9e778721787c21
https://pubmed.ncbi.nlm.nih.gov/8764816
https://pubmed.ncbi.nlm.nih.gov/8764816