American Pharmaceutical Review: A Russell Publishing Publication

Spring 2002

Articles

• A Statistical Approach for the Evaluation of Parameters Affecting Preformulation Studies of Pharmaceuticals by Differential Scanning Calorimetry

  Alan T. Riga, Ph.D.(ab), Shouvik Roy(a), Kenneth S. Alexander, Ph.D.(a) College of Pharmacy, Pharmacy Practice Department, University of Toledo, Ohio(b) Department of Clinical Pharmacy, Cleveland State University, Ohio

• Characterization of Pharmaceutical Solids Using Various Particle Sizing Techniques

  Yuzhuo Li, Xiaojing Shi, and John Westbrook, Center for Advanced Materials Processing (CAMP), Department of Chemistry, Clarkson University, Potsdam, NY

• Developing Consensus-Based Guidances for Orally Inhaled and Nasal Drug Products (The Work of the ITFG/IPAC-RS Collaboration)

  Gordon F. Hansen (a), Carole Evans (b), and Mary Devlin Capizzi (c)(a) Boehringer Ingelheim Pharmaceuticals Inc., (b) Magellan Laboratories Inc.,(c) Gardner, Carton & Douglas - the Health Law Dept and the Pharmaceutical Practice Group

• Electronic Signatures: Systems or Applications?

  R.D. McDowall, Ph.D., McDowall Consulting, Bromley, Kent, UK

• HPLC coupled with tandem mass spectrometry (MS/MS) is well established

  Francis P. Barletta, R.Ph., M.S., MBA

• Investigating Out of Specifications (OOS) Dissolution Results: A Systematic Approach

  Peter Scott, AstraZeneca L.P.: QA Analytical Services-Method Services, Westborough, MA

• Maintaining Aseptic Validation Status by the Effective Use of People (A Look at practical approaches that you will not find in the guidelines)

  Nigel Holcombe, AstraZeneca, Newark, DE

• Masking Science and Technology Applied to Compacted Oral Solid Dosage - Part 1

  Joseph P. Reo, Ph.D. and Jennifer K. Fredrickson, Pharmacia Corporation

• Near-Infrared Spectroscopy for In-Process Moisture Determination of a Potent Active Pharmaceutical Ingredient

  Robert M. Leasure and Michael K. Gangwer, Pharmacia Corporation, Portage, MI

• Process Variability or Process Capability

  Ronald W. Miller, Ph.D. and Dr. David Unger,Bristol-Myers Squibb Global Pharmaceutical Technology & Development

• Raman Spectroscopy — A Powerful Tool for Non-Routine Analysis of Pharmaceuticals

  Adina L. Enculescu and Jeffrey R. Steiginga

• Regulatory Relief for the Use of Analytical Testing Laboratories in the Pharmaceutical Industries

  John R. Markus, Senior Consultant, AAC Consulting Group, Inc.

• The Implications of 21CFR Part 11 for Clinical Research

  Marta Haley Fields, Amgen

• The Resurgence of Column Switching Techniques to Facilitate Rapid LC/MS/MS Based Bioanalysis in Drug Discovery

  Bradley L. Ackermann, Anthony T. Murphy and Michael J. Berna

• Transferring the Lyophilization Process from One Freeze-Dryer to Another

  Dr. Thomas A. Jennings, Phase-Technologies