References
- International Conference on Harmonization (ICH) Guideline. Stability Testing of New Drug Substances and Products. Fed Reg September 22, 1994; 59(183)
- Bulgak A A. Performance Modeling and Analysis of a Pharmaceutical Packaging Line with Discrete Event Simulation. Pharm Technol 1994; 18(3)128–138
- Moran M. Clinical Studies and the Price of Information. Drug Inf J 1992; 26(1)21–29
- Bernstein D F. Investigational Clinical Trial Material Supply Operations in New Product Development. Appl Clin Trials 1993; 2(11)59–69
- Rosette J L. Using Forensic Packaging Science to Improve Pharmaceutical Packaging. Pharm Technol 1997; 21(1)28–38
- Ehrich J A, Berstein D F, Sills K H. Defining the Clinical Supply Process: The Manufacturing, Packaging, and Labeling Protocol. Pharm Technol 1995; 19(3)98–112
- Kumagai A. Good Clinical Practice in Japan. Appl Clin Trials 1994; 3(1)50–54
- Dupin-Spriet T. Clinical Trial Supplies: An Overview of the Proceedings of the Paris, France 1991 DIA Workshop. Drug Inf J 1993; 27(1)109–117
- Labbe E. Clinical Trials in Japan: Overcoming Obstacles. Appl Clin Trials 1995; 4(1)22–23
- Plezia M A. R&D Package Engineering. McNeil Consumer Products Company, Fort Washington, PA 1996, Private Communication to D. M. Dolfini
- Grady T. Prescription Drug Distribution Act. Presentation to the FDA Advisory Stability Committee, Silver Springs, MD 1993
- Galloway-Ludwig S, Garvey C, May D. Investigational Materials Sample Retention Guide. Pharm Engineering 1995; 15(4)44–45
- Fed Reg July 21, 1995; 60(140)16, CFR Part 1700
- Forcino H. Child Resistant Closures: Do Yours Pass the Test. Pharmaceutical & Medical Packaging News 1996; 4(6)41–44
- Bernstein D F, Tiano F J. Preparation, Packaging, and Labeling of Investigational Clinical Supplies. J Clin Res Pharmacoepidemiol 1992; 6: 183–193
- Case History. HPDE Bottle Shields Lescol from Light and Moisture. Pharmaceutical & Medical Packaging News 1995; 3(11)66
- Reiterer F. Blister Packaging for the Pharmaceutical Industry. Pharm Technol 1991; 15(3)74–80
- Jenkins W A, Osborn K R. Packing Drugs and Pharmaceuticals. Technomic Publishing Co., Lancaster, PA 1993; 91
- FDA, Center for Drug Evaluation and Research. Guidelines on General Principles of Process Validation. 1987; 4
- Larson M. Validation Presents New Challenges. Pharmaceutical & Medical packaging News 1994; 2(1)33–36
- Newcorn D. Glaxo-Wellcome Counts Its Savings. Packaging World 1996; 3(9)67–71
- Fed Reg August 28, 1995; 60(182)21, CFR Parts 210 and 211
- Bernstein D. Commonsense Approaches to the Preparation of Investigational Clinical Trial Materials Using the Concepts of Global BMPs, Part II. Pharm Technol 1997; 21(4)56–70
- Beagley K G. Trends in Labeling Today. Pharmaceutical & Medical Packaging News 1996; 4(7)29–32
- Forcinio H. Blister Packaging Enjoys Healthy Growth: Study Shows Format Can Be Cost-Effective. Pharm Technol 1994; 18(11)32–36
- Product Review, Plastic Film Heat Sealing. Packaging May, 1991; 51–52
- Product Spotlight, Carded Blister Machinery. Packaging 1990; 65–66
- Product Breakthroughs, Making The Most Of Horizonal Form-Fill-Seal. Packaging April, 1991; 44–46
- Kelsey R J. Horizontal Pouch Packaging. Food & Drug Packaging January, 1991; 8–14
- Kelsey R J. Basic Principles Of Form-Fill-Seal Pouching. Food & Drug Packaging 1989; 10–15
- Jenkins W A, Osborn K R. Packaging Drugs and Pharmaceuticals. Technomic Publishing Co, Lancaster, PA 1993; 164
- Kelsey R J. The Status Of Leak Detection. Food & Drug Packaging 1990; 8–21
- Sahai H, Khurshid A, Ageel M I. Clinical Trials: An Overview. Appl Clin Trials 1996; 5(12)30–48
- FDA. Code Of Regulations, Current Drug Good Manufacturing Practices for Finished Pharmaceuticals. CFR, 21(211.25)
- Weigand J L, D'Apollo R, Banker J, Capalbo L M, Tiano F J. Clinical Trail Materials Training Guide. International Society for Pharmaceutical Engineering. 1996