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  • Comparative Dissolution Profile CDP Between Generic Product and Comparator Product With Gastro-Resistance Formulation Jun 2016 PDF

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    lhthang1990
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    The document discusses two options for comparing the dissolution profiles of a generic drug product and its comparator with a gastro-resistant formulation. The first option is to conduct dissolution testing according to EMA guidelines, which involves 2 hours in pH 1.2 or pH 4.5 media followed by 45 minutes in pH 6.8 media. The second option is to test dissolution in three separate pH buffers (pH 1.2, 4.5 and 6.8) as outlined in ASEAN's bioequivalence study guidelines.

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    The document discusses two options for comparing the dissolution profiles of a generic drug product and its comparator with a gastro-resistant formulation. The first option is to conduct dissolution testing according to EMA guidelines, which involves 2 hours in pH 1.2 or pH 4.5 media followed by 45 minutes in pH 6.8 media. The second option is to test dissolution in three separate pH buffers (pH 1.2, 4.5 and 6.8) as outlined in ASEAN's bioequivalence study guidelines.

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    27 views1 page

    Comparative Dissolution Profile CDP Between Generic Product and Comparator Product With Gastro-Resistance Formulation Jun 2016 PDF

    Uploaded by

    lhthang1990
    The document discusses two options for comparing the dissolution profiles of a generic drug product and its comparator with a gastro-resistant formulation. The first option is to conduct dissolution testing according to EMA guidelines, which involves 2 hours in pH 1.2 or pH 4.5 media followed by 45 minutes in pH 6.8 media. The second option is to test dissolution in three separate pH buffers (pH 1.2, 4.5 and 6.8) as outlined in ASEAN's bioequivalence study guidelines.

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    © All Rights Reserved
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    of 1

    Comparative Dissolution Profile (CDP) between Generic Product and Comparator Product with

    Gastro-Resistance Formulation

    As agreed upon in ‘Mesyuarat Jawatankuasa Kajian Bioekuivalens Kebangsaan 1/2016’, 16 June 2016:

    There are two (2) options in comparing the dissolution profiles of generic product and comparator
    product with gastro-resistance formulation:-

    (i) According to European Medicines Agency (EMA) Questions & Answers: Positions on Specific
    Questions Addressed to the Pharmacokinetic Working Party (PKWP), 26 June 2015, the in-vitro
    dissolution test should be conducted following the conditions as below:

    a. 2 hours in pH1.2 media followed by 45 minutes in pH6.8 media


    b. 2 hours in pH4.5 media followed by 45 minutes in pH 6.8 media

    (ii) According to ASEAN Guideline for the Conduct of Bioequivalence Studies, March 2015, the in-vitro
    dissolution test should be conducted in three different buffers (pH 1.2, 4.5 and 6.8).

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