American Pharmaceutical Review: A Russell Publishing Publication

September/October 2004

Articles

• Advanced Aseptic Processing and Packaging by Blow-Fill-Seal Technology

  Anders Löfgren, Ph.D., AstraZeneca, Research and Development, Södertälje, Sweden

• Application of FT - Raman and FT - IR Spectroscopy in Pharmaceutical Development

  Sabine Pfeffer - Hennig & Miriam Bellus, Novartis Pharma AG

• CBER's Electronic Submission Program and Document Management System

  Joseph Montgomery, FDA Center for Biologic Evaluation, Research & Review (CBER)

• Crystal Structure Determination: Pushing Back the Boundaries with Laboratory XRPD and Global Optimization

  K. Shankland, Ph.D.¹, A.J. Florence, Ph.D.², N. Shankland, Ph.D.², W.I.F. David¹, A. Johnston, Ph.D.², A.J. Markvardsen, Ph.D.¹, G. Steele,Ph.D.³, S.D. Cosgrove,Ph.D.³

• Dissolution Testing for Solid Oral Drug Products: Theoretical Considerations

  Hua Zhang, Ph.D.¹ and Lawrence X. Yu, Ph.D.², ¹AstraZeneca Pharmaceuticals LP, ²Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs

• Factors Affecting NIR Chemical Images of Solid Dosage Forms

  Fred LaPlant, Ph.D., Analytical Research and Development Pfizer Inc.

• Improving Vaccine Stability, Potency, and Delivery

  Li Shi, Ph.D., Robert K. Evans, Ph.D., and Carl J. Burke, Ph.D., Vaccine Pharmaceutical Research, Pharmaceutical R&D, Merck Research Laboratories

• Leveraging the Use of Modern Mass Spectrometry Instrumentation in Small Molecule Drug Development

  Brent L. Kleintop, Ph.D., Haiying Zhang, Ph.D., and Ken L. Ray, Ph.D., Bristol-Myers Squibb Pharmaceutical Research Institute

• Lyophilizer Qualification: Some Practical Advice

  Thorsten Fischer, ZLB Behring GmbH (formerly Aventis Behring GmbH), Department Facility Qualification

• Nasal and Pulmonary Delivery of Deslorelin, a Peptide Drug

  Sneha Sundaram¹, Sirisha Bontha¹, Kavitha Koushik², and Uday B. Kompella¹ , ¹Department of Pharmaceutical Sciences, University of Nebraska Medical Center, ²Barr Laboratories, Inc.

• NMR-Based Metabonomics in Toxicology Research and Toxicity Testing

  Richard D. Beger, Laura K. Schnackenberg, and Yvonne P. Dragan, Division of Systems Toxicology, Food and Drug Administration

• Overview of Aseptic Fill/Finish Manufacturing

  Douglas Stockdale, President, Stockdale Associates, Inc.

• Quality System for Handling and Managing Special Security Substances

  John R. Kim and Rafik H. Bishara, Ph.D., Eli Lilly and Company

• Relative Filter Pore and Microorganism Sizes: The Conflict Between Science and Marketing – A Pictorial Review

  James Agalloco, Agalloco & Associates, Theodore H. Meltzer, Capitola Consultancy

• Rotor-stator Milling of APIs - Empirical Scale-up Parameters and Theoretical Relationships Between the Morphology and Breakage of Crystals

  Ivan Lee, Ph.D., Narayan Variankaval, Ph.D., Christopher Lindemann & Cindy Starbuck, Ph.D., Merck & Co., Chemical Engineering R&D and Analytical Research