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Aspect of In vitro - In vivo Correlation for Analyzing Complex Dissolution Profile of Atorvastatin

첫 페이지 보기
  • 발행기관
    선문효정학술연구회 바로가기
  • 간행물
    선문효정학술연구회 학술대회 프로시딩 바로가기
  • 통권
    Proceedings of THE 2nd INTERNATIONAL CONFERENCE OF HYOJEONG ACADEMY 2023 (2023.08)바로가기
  • 페이지
    pp.110-110
  • 저자
    Yunjae Hwang, Kiwon Nam, Jaehong Min
  • 언어
    영어(ENG)
  • URL
    https://www.earticle.net/Article/A489249

원문정보

초록

영어
Although generic drugs are designed to contain identical amounts of active pharmaceutical ingredient (API) as the original drugs, it is difficult to achieve bioequivalence (BE) during the development of generic drug. Especially, in vitro dissolution test occasionally appears complex dissolution profile which is tricky to proceed to perform formulation study. Herein, we deeply analyzed the complex dissolution profile of atorvastatin to achieve BE of generic drug. In this context, we interpreted stability of atorvastatin and impurity H in working solution of various pH. After the identification of stable pH range, we calculated relative reaction factor (RRF) value for proper validation process. Our research not only suggest adequate validation and dissolution test are required for generic development, also suggest an aspect of in vitro-in vivo correlation by accurate and precise in vitro analyzing.

목차

Abstracts
Results
Conclusion
References

저자

  • Yunjae Hwang [ IIhwa Co. Ltd. Central Research Institute, Gangdong-gu, Seoul 05288, Korea ]
  • Kiwon Nam [ IIhwa Co. Ltd. Central Research Institute, Gangdong-gu, Seoul 05288, Korea ]
  • Jaehong Min [ IIhwa Co. Ltd. Central Research Institute, Gangdong-gu, Seoul 05288, Korea ]

참고문헌

자료제공 : 네이버학술정보

간행물 정보

발행기관

  • 발행기관명
    선문효정학술연구회 [Sun Moon Hyojeong Academy Society]
  • 설립연도
    2023
  • 분야
    복합학>학제간연구
  • 소개
    Journal of Hyojeong Academia aims to serve as a global platform where researchers and scholars of various disciplines can contribute ideas for our sustainable global community of Co‐existence, Co‐prosperity, and Co‐righteousness. The journal is a multidisciplinary, open‐access, internationally peer‐reviewed academic journal, and it invites all areas of research conducted in the spirit of post materialism including studies centering on God, studies unifying religions and sciences, and studies on all aspects of Co‐existence, Co‐prosperity, and Co‐righteousness.

간행물

  • 간행물명
    선문효정학술연구회 학술대회 프로시딩
  • 간기
    반년간
  • 수록기간
    2023~2026
  • 십진분류
    KDC 238 DDC 289

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