Standardization of uniformity of dosage unit for oral dosage forms

  • Kang, Shin-Jung (Department of Drug Evaluation, Korea Food and Drug Administration) ;
  • Yun, Mi-Ok (Department of Drug Evaluation, Korea Food and Drug Administratio) ;
  • Choi, Hyun-Cheol (Department of Drug Evaluation, Korea Food and Drug Administratio) ;
  • Kim, Ho-Jeong (Department of Drug Evaluation, Korea Food and Drug Administratio) ;
  • Kim, Ji-Sun (Department of Drug Evaluation, Korea Food and Drug Administratio) ;
  • Kim, Gil-Su (Department of Drug Evaluation, Korea Food and Drug Administration)
  • Published : 2002.10.01

Abstract

To secure the safety of drugs without compromising drug efficacy, it can not be more important to administer the exact intended amount of active ingredients to patients. Even if the correct amount of drugs are taken in the correct manner, drug can be overdosed or less-dosed without intention unless the content uniformity of the unit dose were secured. Especially, it can be a serious problem when it comes to drugs with narrow therapeutic windows or a strong pharmacological activity at a small dose. (omitted)

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