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

Author:

Siewert Martin,Dressman Jennifer,Brown Cynthia K.,Shah Vinod P.,Aiache Jean-Marc,Aoyagi Nobuo,Bashaw Dennis,Brown Cynthia,Brown William,Burgess Diane,Crison John,DeLuca Patrick,Djerki Ruzica,Dressman Jennifer,Foster Thomas,Gjellan Kirsti,Gray Vivian,Hussain Ajaz,Ingallinera Tom,Klancke James,Kraemer Johannes,Kristensen Henning,Kumi Kofi,Leuner Christian,Limberg Jobst,Loos Petra,Margulis Lenny,Marroum Patrick,Moeller Helga,Mueller Bernd,Mueller-Zsigmondy Martin,Okafo Ngozi,Ouderkirk Larry,Parsi Shravan,Qureshi Saeed,Robinson Joseph,Shah Vinod,Siewert Martin,Uppoor Ramana,Williams Roger

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference22 articles.

1. FIP guidelines for dissolution testing of solid oral products [Duplicate publication of FIP guidelines for dissolution testing of solid oral products. Pharm Ind. 1997;59:760–766]. Dissolut Technol. 1997;4:5–14.

2. FDA guidance for Industry: dissolution testing of immediate release solid oral dosage forms, August 1997; extended release solid oral dosage forms: development, evaluation and application of in vitro/in vivo correlations, September 1997.

3. USP 24/NF 19, 〈1088〉 2000:2051.

4. FDA Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations. October 2000.

5. Shah VP, Tymes NW, Skelly JP. In vitro release profile of clonidine transdermal therapeutic systems and scopolamine patches. Pharm Res. 1989;6:346–351.

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