Biopharmaceutical characterization of sotalol-containing oral immediate release drug products

Author:

Alt Axel,Potthast Henrike,Moessinger Juergen,Sickmüller Barbara,Oeser Helga

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference26 articles.

1. FDA Guidance for Industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms containing certain active moieties/active ingredients based on a Biopharmaceutics Classification System, CDER/FDA, August 2000.

2. EC CPMC Working Party on Quality of Medicinal Products, Note for Guidance on the Investigation of Bioavailability and Bioequivalence, CPMP/EWP/QWP/1401/98, January 2002.

3. BfArM Announcement for the authorisation of medicinal products according to § 21 of the German Drug Law (Bioavailability and Bioequivalence) as of December 18, 2002, Banz. (Bundesanzeiger, German Official Journal): No. 58 of March, 25.

4. Quantitative structure-retention and retention-activity relationships of β-blocking agents by micellar liquid chromatography;Detroyer;J. Chromatogr.,2001

5. European Pharmacopoeia, fourth ed,2002

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