Pharmacy & Therapeutics - October 2008 - (Page PP16) PRODUCT PROFILER: Granisetron Transdermal Delivery System Table 7 Equivalence Tests between Transdermal Granisetron and Placebo for Irritation Scores Parameter Mean cumulative irritation (MCI) score Total cumulative irritation (TCI) score From Study 392MD/26/C, p 44.15 Granisetron TDS Mean SD Mean SD 0.64 0.54 1.92 1.63 Placebo 1.00 0.67 3.00 2.00 Non-inferiority Test (P) P < 0.0001 P 90% 119 (59.20) 168 (83.58) 159 (79.10) 139 (69.15) 187 (93.50) 181 (90.50) Patch Adhered 75%–90% 71 (35.32) 31 (15.42) 34 (16.92) 55 (27.36) 12 (6.00) 16 (8.00) Patch Adhered 50%–74% 11 (5.47) 2 (1.00) 7 (3.48) 7 (3.48) 1 (0.50) 3 (1.50) Patch Adhered <50% 0 (0.00) 0 (0.00) 1 (0.50) 0 (0.00) 0 (0.00) 0 (0.00) Day 8 Total 201 201 201 201 200 (*) 200 (*) Granisetron 15 22 8 Placebo 15 22 (*) = one missing piece of data at Day 15 and Day 22 for the placebo patch. From Study 392M/26/C, p 45.15 Table 9 Subjective Symptoms during the Induction Phase on Days of Patch Removal Granisetron Days n (%) Pruritus Stinging Burning Others 8 94 (46.77) 20 (9.95) 6 (2.99) 0 (0.00) 15 96 (47.76) 16 (7.96) 6 (2.99) 0 (0.00) 22 81 (40.30) 12 (5.97) 2 (1.00) 0 (0.00) 8 100 (49.75) 16 (7.96) 7 (3.48) 0 (0.00) Placebo Days 15 88 (44.00) 12 (6.00) 6 (3.00) 0 (0.00) 22 88 (44.00) 11 (5.50) 5 (2.50) 0 (0.00) From Study 392M/26/C, p 45.15 study. The most frequently reported AEs—headache (28.8%) and constipation (32.2%)—were anticipated because of the product’s characteristics. Five percent of AEs, thought to be related to the study products, 16 were severe; the rest of the AEs were categorized as mild (41.9%) to moderate (53.1%) in nature. In the induction phase, the patches were applied for three consecutive weeks to the same skin area, but in
Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - October 2008 Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso® Pharmacy & Therapeutics - October 2008 Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page Cover1) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page Welcome) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 555) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 556) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 557) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 558) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 559) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 560) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 561) Pharmacy & Therapeutics - October 2008 - Contents (Page 562) Pharmacy & Therapeutics - October 2008 - Contents (Page 563) Pharmacy & Therapeutics - October 2008 - Contents (Page 564) Pharmacy & Therapeutics - October 2008 - Contents (Page 565) Pharmacy & Therapeutics - October 2008 - Editorial (Page 566) Pharmacy & Therapeutics - October 2008 - Medication Errors (Page 567) Pharmacy & Therapeutics - October 2008 - Medication Errors (Page 568) Pharmacy & Therapeutics - October 2008 - Prescription: Washington (Page 569) Pharmacy & Therapeutics - October 2008 - New Drugs/Drug News/ New Medical Devices (Page 570) Pharmacy & Therapeutics - October 2008 - New Drugs/Drug News/ New Medical Devices (Page 571) Pharmacy & Therapeutics - October 2008 - New Drugs/Drug News/ New Medical Devices (Page 572) Pharmacy & Therapeutics - October 2008 - New Drugs/Drug News/ New Medical Devices (Page 573) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 574) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 575) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 576) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 577) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 578) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 579) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 580) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 581) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 582) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 583) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 584) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 585) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 586) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 587) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 588) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 589) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 590) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 591) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 592) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 593) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 594) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 595) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 596) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 597) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 598) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 599) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 600) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 601) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 602) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 603) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 604) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 605) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 606) Pharmacy & Therapeutics - October 2008 - Why Is Health Care Regulation So Complex? (Page 607) Pharmacy & Therapeutics - October 2008 - Why Is Health Care Regulation So Complex? (Page 608) Pharmacy & Therapeutics - October 2008 - The Next President’s Prescription for Action on Drugs (Page 609) Pharmacy & Therapeutics - October 2008 - The Next President’s Prescription for Action on Drugs (Page 610) Pharmacy & Therapeutics - October 2008 - Trends in Managing Multiple Sclerosis (Page 611) Pharmacy & Therapeutics - October 2008 - Trends in Managing Multiple Sclerosis (Page 612) Pharmacy & Therapeutics - October 2008 - Trends in Managing Multiple Sclerosis (Page 613) Pharmacy & Therapeutics - October 2008 - Trends in Managing Multiple Sclerosis (Page 614) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PPCover1) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PPCover2) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP1) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP2) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP3) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP4) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP5) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP6) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP7) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP8) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP9) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP10) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP11) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP12) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP13) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP14) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP15) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP16) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP17) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP18) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP19) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP20) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP21) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP22) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP23) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP24) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP25) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP26) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP27) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP28) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP29) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page Cover4)
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