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FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms

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Author information

Authors and Affiliations

  1. FIP Dissolution Working Group, Aventis Pharma AG, D-65926, Frankfurt am Main, Germany

    Martin Siewert & Martin Siewert (Contributor)

  2. JW Goethe University, Frankfurt, Germany

    Jennifer Dressman, Jennifer Dressman (Contributor) & Christian Leuner (Contributor)

  3. Eli Lilly and Company, Indianapolis, IN

    Cynthia K. Brown & Cynthia Brown (Contributor)

  4. Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD

    Vinod P. Shah, Dennis Bashaw (Contributor), Ajaz Hussain (Contributor), Kofi Kumi (Contributor), Patrick Marroum (Contributor), Larry Ouderkirk (Contributor), Vinod Shah (Contributor) & Ramana Uppoor (Contributor)

  5. Université d Auvergne, Clermont-Ferrand Cedex, France

    Jean-Marc Aiache (Contributor)

  6. Division of Drugs, National Institute of Health Sciences, Tokyo, Japan

    Nobuo Aoyagi (Contributor)

  7. US Pharmacopeia, Rockville, MD

    William Brown (Contributor) & Roger Williams (Contributor)

  8. University of Connecticut, Storrs Mansfield, CT

    Diane Burgess (Contributor)

  9. Pfizer, Inc, La Jolla, CA

    John Crison (Contributor)

  10. University of Kentucky, Lexington, KY

    Patrick DeLuca (Contributor) & Thomas Foster (Contributor)

  11. Novartis Pharma, Basel, Switzerland

    Ruzica Djerki (Contributor) & Martin Mueller-Zsigmondy (Contributor)

  12. AstraZeneca, Sodertalje, Sweden

    Kirsti Gjellan (Contributor)

  13. V.A. Gray Consulting, Inc, Hockessin, DE

    Vivian Gray (Contributor)

  14. AAI International, Charleston, SC

    Tom Ingallinera (Contributor)

  15. CIMA Laboratories, Inc, Minneapolis, MN

    James Klancke (Contributor)

  16. Laboratory and Quality Services, Eschborn, Germany

    Johannes Kraemer (Contributor)

  17. University of Copenhagen, Denmark

    Henning Kristensen (Contributor)

  18. Bundesinstitut für Arzneimittel, Bonn, Germany

    Jobst Limberg (Contributor)

  19. Aventis Pharmaceuticals, Bridgewater, NJ

    Petra Loos (Contributor)

  20. Pfizer, Groton, CT

    Lenny Margulis (Contributor)

  21. Zentrallaboratorium Deutscher Apotheker, Eschborn, Germany

    Helga Moeller (Contributor)

  22. Kiel University, Kiel, Germany

    Bernd Mueller (Contributor)

  23. Alza Corporation, Mountain View, CA

    Ngozi Okafo (Contributor)

  24. DPT Laboratories, Ltd, San Antonio, TX

    Shravan Parsi (Contributor)

  25. Health Protection Branch, Ottawa, Canada

    Saeed Qureshi (Contributor)

  26. University of Wisconsin, WI

    Joseph Robinson (Contributor)

Authors
  1. Martin Siewert
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  2. Jennifer Dressman
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  3. Cynthia K. Brown
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  4. Vinod P. Shah
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  5. Jean-Marc Aiache
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  6. Nobuo Aoyagi
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  7. Dennis Bashaw
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  8. Cynthia Brown
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  9. William Brown
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  10. Diane Burgess
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  11. John Crison
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  12. Patrick DeLuca
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  13. Ruzica Djerki
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  14. Jennifer Dressman
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  15. Thomas Foster
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  16. Kirsti Gjellan
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  17. Vivian Gray
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  18. Ajaz Hussain
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  19. Tom Ingallinera
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  20. James Klancke
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  21. Johannes Kraemer
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  22. Henning Kristensen
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  23. Kofi Kumi
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  24. Christian Leuner
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  25. Jobst Limberg
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  26. Petra Loos
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  27. Lenny Margulis
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  28. Patrick Marroum
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  29. Helga Moeller
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  30. Bernd Mueller
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  31. Martin Mueller-Zsigmondy
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  32. Ngozi Okafo
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  33. Larry Ouderkirk
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  34. Shravan Parsi
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  35. Saeed Qureshi
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  36. Joseph Robinson
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  37. Vinod Shah
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  38. Martin Siewert
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  39. Ramana Uppoor
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  40. Roger Williams
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Additional information

This article represents the scientific opinion of many experts and, in particular, is derived from a series of workshops held under the auspices of the Federation International Pharmaceutique (FIP) and cosponsored by the Royal Pharmaceutical Society (UK), the Bundesverband der Pharmazeutischen Industrie (BPI), Colloquium Pharmaceuticum (Germany), the American Association of Pharmaceutical Scientists (AAPS, US), and the US Food and Drug Administration. It is now presented as an FIP and AAPS position paper to support activities, programs, and decisions in the scientific, technical, and regulatory community. Even though it is a “final” position paper at this stage, the authors expect further progress to be made rapidly in the relevant areas. Thus, comments and additional contributions are welcome and may be considered for a revision of the position paper in due course.

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Siewert, M., Dressman, J., Brown, C.K. et al. FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSciTech 4, 7 (2003). https://doi.org/10.1208/pt040107

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  • DOI: https://doi.org/10.1208/pt040107

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