Articles

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  • From the Editor: Into the Light

    Drug manufacturing can only advance if drugmakers, regulators, academics and vendors join forces to mine and interpret new data.

    12/08/2006
  • Tech Transfer: Don't Fumble the Hand Off

    Technology transfer was once taken for granted as something that would “get done anyway.” Now it’s an indicator of manufacturing excellence and a core competency for drug innovators.

    Angelo De Palma, Ph.D., Contributing Editor
    12/08/2006
  • Dissolution Testing in the 21st Century

    The Hot Topic session on dissolution testing at the recent AAPS Annual Meeting put PAT expert Ajaz Hussain on the hot seat in a debate over the applicability of a "testing tablet" to determining the stability of a solid dosage form.

    Bill Swichtenberg, Senior Editor
    12/06/2006
  • On-demand Data Access and Analytics Enable Decisions for Process Excellence

    Critical to any PAT effort is having a single point of easy, on-demand access to all relevant data, in a context that’s meaningful to diverse groups of users. But data must be presented in a way that facilitates the identification and understanding of cause-and-effect relationships. Justin Neway, CSO and EVP of Aegis Analytics, talks about the issues and what they mean for PAT-related IT.

    Justin O. Neway, Ph.D., EVP and Chief Science Officer, Aegis Analytical Corp.
    12/06/2006
  • [The Problem with] Not Having a Personal Life Plan

    A business consultant and professional motivator, John McKee asserts that women face significant obstacles to professional growth and urges men in management to help women surmount those obstacles. In this excerpt from his book, "21 Ways Women in Management Shoot Themselves in the Foot," McKee discusses the reasons for and benefits of outlining a life plan.

    John M. McKee, BusinessSuccessCoach.net and Four Windows - No Walls Consulting, LLC
    12/05/2006
  • PAT in Perspective: Safe? Yes. Effective? Not So Much.

    PAT expert Emil Ciurczak points out that a repository of methods and standard practices, terms, units, etc. is critical to understanding (and thus controlling) the process of producing good, predictable, and reproducible solid dosage forms.

    Emil W. Ciurczak, Cadrai Technology Group
    12/05/2006
  • A Closer Look at Form-Fill-Seal Technology

    Cost efficiencies are driving increased use of FFS in liquid parenteral drug packaging, but attention to process parameters, testing and validation is critical

    Rakesh P. Patel, Gayatri C. Patel, Nikunjana A. Patel, Dr. Madhabhai M. Patel and Rishad Jivani, S.K. Patel College of Pharmaceutical Education and Research, Ganpat University, Gujarat, India
    11/25/2006
  • Macher and Nickerson on Benchmarking Pharma and FDA

    Georgetown Professor Jeffrey Macher and Washington University Professor Jackson Nickerson discuss their extensive benchmarking project, which analyzed FDA regulation, in particular cGMP inspections, as well as industry manufacturing performance.

    Agnes Shanley, Editor in Chief
    11/20/2006
  • Analyze This!

    The 450-page Pharmaceutical Manufacturing benchmarking study released in October offers a gold mine of information on how to improve, for those industry professionals and regulators brave enough to dive into the data. In this feature, Jeff Macher and Jackson Nickerson discuss challenges they faced, study results, a major caveat and future plans.

    Agnes Shanley, Editor in Chief
    11/20/2006
  • Talecris Makes Manufacturing Professionals Industry Ambassadors

    GSK has sent its sales reps out to improve the industry's image, but last August, Talecris Biotherapeutics allowed its manufacturing and development staff to become industry spokespeople. Could this be the wave of the future for pharma?

    Agnes Shanley, Editor in Chief
    11/13/2006
  • Ten Steps to Process Improvement, Part 1

    Six Sigma can, and should, become a way of life for mid-level manufacturing executives, directors and managers.

    Ronald D. Snee, Ph.D., Principal, Tunnell Consulting, Inc.
    11/13/2006
  • Take Our New Survey on FDA-Pharma Manufacturer Relations

    We invite you to share your views on how the FDA's move to risk- and science-based regulation is changing plant inspections, interactions with the Agency, and drug manufacturing in general. Ten respondents, selected at random, will earn $50 Starbucks gift cards.

    11/13/2006
  • Running with (and from) the Wolf Pack

    This interview with Dr. Peter Rost examines his career before and after Pharmacia and Pfizer, and his new writing career

    Ed Silverman and Agnes Shanley
    11/02/2006
  • Transcript: Peter Rost Talks Turkey with Ed Silverman

    This article contains the full transcription of Ed Silverman's interview with Peter Rost (the briefer, edited interview is available for download as a Windows Media video).

    Ed Silverman and Agnes Shanley
    11/02/2006
  • Drug Delivery: The "Great Equalizer"

    Critical to improving performance and extending patent life, drug delivery is the only area where the small often trump megapharmas

    Angelo De Palma, Ph.D., Contributing Editor
    10/19/2006
  • Visualizing the Dynamics of Fluid-Bed Dryers

    A team at the University of Saskatchewan is applying tomography to the study of fluid bed dryers in a bid to make proper operation of the equipment easier and clearer.

    10/19/2006
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