David Bernstein PublicationsSelected publications are available electronically from David Bernstein. The Integration of Chemistry, Manufacturing and Controls (CMC) into Drug Development Avoiding the Common Delays; Bernstein DF: in Expediting Drug and Biologics Development, S. Linberg, Ph.D., ed. published in 2006 Integration of CMC into Drug Development: Eight Rules to Proactively Avoid Common Problems; Bernstein DF: Product and Formulation Quality, Feb/March 2005 (part 1) and June/July 2005 (part 2) Translating Cutting-Edge Academic Science into Biotech Drugs; Bernstein DF, Hamrell M and Pavliv L: Contract Pharma, September 2003 Integrating Drug Supply Issues with Strategic Preclinical and Clinical Development; Bernstein DF, Hamrell M: Drug Information Journal, August 2000. Using Global GMP Regulations and Guidance to Define Best Practices for Clinical Supply Operations (CSO); Bernstein DF: Technical Guide, Institute Validation Technology, June 2000. A Century's Retrospective on Clinical Trial Materials; Tiano F, Carney C, Jeiven M, Bernstein DF: Applied Clinical Trials, February 2000. Clinical Supplies or Clinical Surprise?; Teichman S, Kenley R, Bernstein DF: Applied Clinical Trials, October 1999. Improve Communication with the Clinical Supplies Department to Speed Clinical Studies; Bernstein DF, Hamrell M: Applied Clinical Trials, September 1999. CTM at the Interface of GCP and GMP; Bernstein DF: Applied Clinical Trials, May 1999. CTM's Unique Requirements Affect Production Approaches; Bernstein DF: Applied Clinical Trials, March 1999; also in Pharmaceutical Technology, April 1999. Managing Clinical Trial Materials: Customized Fuel for Drug Development; Bernstein DF: Applied Clinical Trials, January, 1999; also in Pharmaceutical Technology, February 1999. Using Global GMP Regulations and Guidance to Define Best Practices for Clinical Supply Operations (CSO), Part One; Bernstein DF, Keicher P: Journal of cGMP Compliance, January 1999. Part Two; Journal of cGMP Compliance, April 1999. Also published in Pharm Tech Japan, April and May 1999. Dosage Form and Drug Substance Specifications: Proven Strategies for Navigating Through ICH and FDA Guidelines; Bernstein DF: Current Drugs Ltd, December 1998. Statistical Planning and Clinical Supplies; Bernstein DF, Grimes I: Applied Clinical Trials, September 1998. Hints for Selecting Contractors for the Preparation of Clinical Trial Materials (CTM); Bernstein DF: The Biotech Journal, September 1998. The Manufacturing, Packaging and Labeling (MPL) Protocol: Packaging, Labeling and Assembly Operations, Analytical Testing and Ancillary Operations; Bernstein DF, Ehrich JA, Sills KH: Pharmaceutical Engineering, September/October 1997. Common sense approaches to the preparation of investigational clinical trial materials using the concepts of global GMPs, part II; Bernstein DF: Pharmaceutical Technology, April 1997. Common sense approaches to the preparation of investigational clinical trial materials using the concepts of global GMPs, part I; Bernstein DF: Pharmaceutical Technology, March 1997. Defining the clinical supply process: the manufacturing, packaging and labeling protocol; Bernstein DF, Ehrich JA, Sills KH: Pharmaceutical Technology, Volume 19, Number 3, March 1995. Clinical supplies: manufacturing, packaging and labeling protocols; Bernstein DF, Ehrich JA, Sills KH: Applied Clinical Trials, Volume 4, Number 3, March 1995. GMPs in R&D: Good science, good common sense; Bernstein DF: BioPharm, Volume 8, Number 1, January - February, 1995. Investigational clinical trial material supply operations in new product development; Bernstein DF: Applied Clinical Trials, November 1993; also in Pharmaceutical Technology, February 1994; also in Journal of Clinical Research Pharmacoepidemiology, June 1994. Preparation, packaging, and labeling of investigational clinical supplies. Part II: Packaging of investigational clinical supplies; Bernstein DF, Tiano FJ: Journal of Clinical Research Pharmacoepidemiology, June 1992. Preparation, packaging, and labeling of investigational drug supplies. Part I: Preparation of investigational drug supplies; Bernstein DF, Tiano FJ: Journal of Clinical Research Pharmacoepidemiology, May 1991. Effect of vehicle amphiphilicity on the dissolution and bioavailability of a poorly water soluble drug from solid dispersions; Serrajuddin ATM, Sheen PC, Mufson D, Bernstein DF, Augustine MA: Journal Pharmaceutical Sciences, May 1988. Physicochemical basis of increased bioavailability of a poorly water soluble drug following oral administration as organic solutions; Serrajuddin ATM, Sheen PC, Mufson D, Bernstein DF, Augustine MA: Journal of Pharmaceutical Sciences, April 1988. Studies on the light stability of flordipine tablets in amber blister packaging material; Narurkar AN, Sheen PC, Bernstein DF, Augustine MA: Drug Development and Industrial Pharmacy, August 1986. Preformulation study of a poorly water soluble drug, alpha-pentyl-3-(2-quinolinylmethoxy) benzenemethanol: selection of the base for dosage form design; Serrajuddin ATM, Sheen PC, Mufson D, Bernstein DF, Augustine MA: Journal Pharmaceutical Sciences, May 1986. Water migration from soft gelatin capsule shell to fill material and its effect on drug solubility; Serrajuddin ATM, Sheen PC, Bernstein DF, Mufson D: Journal Pharmaceutical Sciences, January 1986. Aspects of wax interactions in the formulations of cosmetic cold creams; Bernstein DF: Journal of the Society of Cosmetic Chemists, January 1982. Effect of formulation variables on the efficacy of pediculicidal topical products; Gerberg E and Bernstein DF: Bull. Biochemistry, September 1979 |
|
