American Pharmaceutical Review: A Russell Publishing Publication

Spring 2003

Articles

• CBER Electronic Submissions - The Vision

  Michael B. Fauntleroy ,Food and Drug Administration, Center for Biologics Evaluation and Research

• Characterization and Analysis of Pharmaceuticals I. Multiple and In-Tandem Thermal Analytical Techniques

  Alan Riga(a,c) Rui Macêdo(b),Ken Alexander(c) and Gene C. Pan(d)a. Department of Chemistry, Cleveland State University

• Chemometric Models Using Diamond Attenuated Total Reflectance IR and Raman Spectroscopy to Characterize and Quantitate Polymorphs in Pharmaceuticals

  Teresa Head and Jim Rydzak, GlaxoSmithKline

• Cost Effective Part 11 Compliance for Laboratory Information Management Systems

  Sandy Weinberg, Ph.D., Linnaeus Chair of Biomedical Entrepreneurship, Muhlenberg College

• Critical Overview of the Proposed Particle Size Analysis Tests

  Harry G. Brittain, Ph.D. and Gregory Amidon, Ph.D.,Center for Pharmaceutical Physics and Pharmacia Corporation

• Dissolution Assay Development for In Vitro-In Vivo Correlations

  Brian R. Rohrs, Ph.D.,Pharmacia Corporation

• Filtration Issues in Pharmaceutical Manufacturing: Bacterial and Viral Retention

  Paul Stinavage, Ph.D.,Food and Drug Administration, Center for Drug Evaluation and Research

• GMP Roll Out and Implementation of Near Infrared Spectrophotometry for Pharmaceutical Testing

  Gary E. Ritchie, Principal Scientist, Saeed Hashemi, Scientist,Purdue Pharma LP, International Research & Development (U.S.)

• Inspection and Maintenance of Compression Tooling

  William Supplee , McNeil Consumer Healthcare

• Integration of High Throughput Screening Methodologies and Manual Processes for Solid Form Selection

  Richard A. Storey, Ph.D., Robert Docherty, Ph.D., & Paul D. Higginson,Pharmaceutical Sciences, Pfizer Global R&D, Sandwich, Kent, UK

• Investigations into Anomalies Arising in the Preparation of Biological Standards in Ampoules and Steps for Process Optimization

  Paul Matejtschuk(1*), Michelle Andersen(1), Roland Fleck(2), Colin Longstaff(3), Peter Phillips(1), Standards(1), Cell Biology & Imaging(2) and Haematology(3) Divisions, National Institute for Biological Standards & Control

• Liquid Filling in Hard Gelatin Capsules: Formulation and Processing Consideration

  Navnit Shah, Ph.D., Wantanee Phuapradit, Ph.D. and Hashim Ahmed, Ph.D., Hoffmann-La Roche Inc.

• Process Analytical Technology (PAT) Part 2

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

• Receptor Phosphorylation in a Cell-Based Assay as a Screen for Receptor Modulators

  Lisa K. Minor, Ph.D.,Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

• Risk Factors in Aseptic Processing

  Richard L. Friedman & Stephen C. Mahoney, Food and Drug Administration, Center for Drug Evaluation and Research