Chinese Journal of Pharmaceuticals, Volume. 56, Issue 7, 956(2025)

Concerns about Quality Study and Specification of Oral Suspensions

SHEN Jili, WANG Zhidong, FU Meng, and ZHANG Xinfang*
Author Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022
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    References(16)

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    [12] [12] ICH. M9: Biopharmaceutics classification system-based biowaivers and Q & As on biopharmaceutics classification system-based biowaivers [EB/OL]. (2019-11-20) [2025-03-10]. https://www.ich.org/page/multidisciplinaryguidelines.

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    [16] [16] FDA. Specific product guidance: methylphenidate hydrochloride_draft_oral suspension [EB/OL]. [2025-03-10]. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate%20Hydrochloride_draft_Oral%20suspER_RLD%20202100_RC12-14.pdf.

    [18] [18] WHO. QAS_Dissolution_test_for_solid_oral_dosage_forms[EB/OL]. (2020-06)[2025-03-10]. https://www.who.int/docs/default-source/medicines/norms-and-standards/current-projects/qas20-837-dissolution-test-for-solid-oral-dosage-forms.pdf.

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    SHEN Jili, WANG Zhidong, FU Meng, ZHANG Xinfang. Concerns about Quality Study and Specification of Oral Suspensions[J]. Chinese Journal of Pharmaceuticals, 2025, 56(7): 956

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    Paper Information

    Category:

    Received: Mar. 10, 2025

    Accepted: Aug. 26, 2025

    Published Online: Aug. 26, 2025

    The Author Email: ZHANG Xinfang (zhangxf@cde.org.cn)

    DOI:10.16522/j.cnki.cjph.2025.07.016

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