Tablets & Capsules

TC1014B

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Tablets & Capsules October 2014 13 References 1. Felton LA, Raisch DW. The New Drug Approval Process and Clinical Trial Design. In: Allen LV, editor. Remington: The Science and Practice of Pharmacy. 22nd ed. London: Pharmaceutical Press; 2013. p. 25-36. 2. Felton LA, Wiley CJ. Blinding controlled-release tablets for clinical trials. Drug Dev Ind Pharm. 2003;29(1):9-18. 3. Carney CF, Killeen MJ, Schulteis WM. Comparator drugs for clinical trials. Pharm Eng. 1997;17(2):48-56. 4. Ku MS, Li WY, Dulin W, Donahue F, Hutchison K, et al. Performance qualification of a new hypromellose capsule: Part I. Comparative evaluation of physical, mechanical and processability quality attributes of Vcaps Plus, Quali-V and gelatin capsules. Int J Pharm. 2010;386:30-41. 5. Grillo D, Polla G, Vega D. Conformational poly- morphism on imatinib mesylate: Grinding effects. J Pharm Sci. 2012;101:541-51. 6. Montano K, Moya R, Mergard L, Eden G, Lueddeke F, Hickey J, et al. Intentional logo bridging with aqueous- based polymeric film coatings to blind debossed tablets for use in clinical studies. American Association of Pharmaceutical Scientists; Chicago, IL, 2012. 7. Automated ink-removal system from Race Rock Associates, Green Cove Springs, FL. 8. Haakenson C, Akiyama T, Hallstrom A, Sather MR. Masking drug treatments in the Cardiac Arrhythmia Pilot Study (CAPS). Control Clin Trials. 1996;17:294-303. Linda A. Felton, PhD, is professor and chair of the Department of Pharmaceutical Sciences at the University of New Mexico, MSC09 5360, 1 UNM, Albuquerque, NM 87131. Her research focuses on modified-release drug delivery systems. She holds a joint appointment to the Department of Veteran's Affairs Cooperative Studies Program, where she is responsible for for- mulation development of oral solids for clinical trials. Cody J. Wiley, MS, is a health sciences research tech II in the Depart- ment of Pharmaceutical Sciences at the University of New Mexico. His research focuses on drug product formulation and analytical testing of drug delivery systems. Bruce C. Cathcart, BS, is a partner and mechanical engineer at Race Rock Asso- ciates, 411 Walnut Street, Unit 5714, Green Cove Springs, FL 32043. Tel. 860 572 0122. Website: www.racerock.net. The company designs and manufactures custom equipment for the pharmaceutical and medical device industries.

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