In silico prediction of bioequivalence of Isosorbide Mononitrate tablets with different dissolution profiles using PBPK modeling and simulation

Author:

Zhang Fan,Zhou Yinping,Wu Ni,Jia Ranran,Liu Aijing,Liu Bo,Zhou ZhouORCID,Hu Haitang,Han Zhihui,Ye Xiang,Ding Ying,He Qing,Wang Hongyun

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference39 articles.

1. Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs;Kortejärvi;Journal of pharmaceutical sciences,2010

2. Food and Drug Administration (FDA). Guidance for Industry: Waiver on In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. 2017 [cited 2020 Jun 20]. Available from: https://www.fda.gov/media/70963/download.

3. European Medicine Agency (EMA). Guideline on the investigation of bioequivalence. 2010 [cited 2020 Jun 20]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf.

4. World Health Organization (WHO). Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 6). 2015 [cited 2020 Jun 20]. Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/trs1003_annex6.pdf?ua=1.

5. Brazilian Health Surveillance Agency (ANVISA). The publication of the list of pharmaceuticals applied for bio-protection based on the biopharmaceutical class system (SCB). 2014 [cited 2020 Jun 20]. Available from: http://portal.anvisa.gov.br/documents/33836/349509/IN%2B07%2B2014.pdf/0996340b-24e54855-8bfd-0756765e422e?version=1.0.

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