지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
오류제보하기
Objectives : To introduce to TKM scientific dose conversion methods of human to animal or animal to human for new drug investigations.
Methods : We searched guidelines of the FDA and KFDA, and compared them with references for drug-dose conversion from various databases such as PubMed and Google. Then, we analyzed the potential issues and problems related to dose conversion in safety documentation of new herbal drugs based on our experiences during Investigational New Drug (IND) applications of TKM.
Results : Dose conversion from human to animal or animal to human must be appropriately translated during new drug development. From time to time, investigators have some difficulty in determining the appropriate dose, because of misunderstandings of dose conversion, especially when they estimate starting dose in clinical or animal studies to investigate efficacy, toxicology and mechanisms. Therefore, education of appropriate dose calculation is crucial for investigators. The animal dose should not be extrapolated to humans by a simple conversion method based only on body weight, because many studies suggest the normalization method is based mainly on body surface area (BSA). In general, the body surface area seems to have good correlation among species with several parameters including oxygen utilization, caloric expenditure, basal metabolism, blood volume and circulating plasma protein. Likewise, a safety factor should be taken into consideration when deciding high dose in animal toxicology study.
Conclusion : Herein, we explain the significance of dose conversion based on body surface area and starting dose estimation for clinical trials with safety factor.
Methods : We searched guidelines of the FDA and KFDA, and compared them with references for drug-dose conversion from various databases such as PubMed and Google. Then, we analyzed the potential issues and problems related to dose conversion in safety documentation of new herbal drugs based on our experiences during Investigational New Drug (IND) applications of TKM.
Results : Dose conversion from human to animal or animal to human must be appropriately translated during new drug development. From time to time, investigators have some difficulty in determining the appropriate dose, because of misunderstandings of dose conversion, especially when they estimate starting dose in clinical or animal studies to investigate efficacy, toxicology and mechanisms. Therefore, education of appropriate dose calculation is crucial for investigators. The animal dose should not be extrapolated to humans by a simple conversion method based only on body weight, because many studies suggest the normalization method is based mainly on body surface area (BSA). In general, the body surface area seems to have good correlation among species with several parameters including oxygen utilization, caloric expenditure, basal metabolism, blood volume and circulating plasma protein. Likewise, a safety factor should be taken into consideration when deciding high dose in animal toxicology study.
Conclusion : Herein, we explain the significance of dose conversion based on body surface area and starting dose estimation for clinical trials with safety factor.
목차
Introduction
Materials and Methods
Results and Discussion
Conclusion
Acknowledgment
References
참고문헌 (13)
참고문헌 신청
1. [학술지(정기간행물)] - Satoh N / 2005 / A randomized double blind placebo-controlled clinical trial of Hochuekkito, a traditional herbal medicine, in the treatment of elderly patients with weakness N of one and responder restricted design / Phytomedicine 12 : 549 ~ 554
2. [기타자료] - Matsumoto T / 2008 / Hochuekkito, a Kampo (Traditional Japanese Herbal) Medicine, and its Polysaccharide Portion Stimulate G-CSF Secretion from Intestinal Epithelial Cells / Evid Based Complement Alternat Med.
3. [학술지(정기간행물)] - Tajima S / 2007 / Preventive effect of hochu-ekki-to, a Japanese herbal medicine, on bleomycin-induced lung injury in mice / Respirology 12 : 814 ~ 822
4. [단행본] - Gad SC / 1998 / Acute Toxicology: Principles and Methods. 2nd rev. rev. ed / Academic Press
5. [학술지(정기간행물)] - Dreyer G / 1910 / The blood volume of mammals as determined by experiments upon rabbits, guinea pigs and mice and its relationship to the body weight and to the body surface area expressed as a formula / Phil. Trans. Royal Soc 201 : 1330 ~ 1360
2. [기타자료] - Matsumoto T / 2008 / Hochuekkito, a Kampo (Traditional Japanese Herbal) Medicine, and its Polysaccharide Portion Stimulate G-CSF Secretion from Intestinal Epithelial Cells / Evid Based Complement Alternat Med.
3. [학술지(정기간행물)] - Tajima S / 2007 / Preventive effect of hochu-ekki-to, a Japanese herbal medicine, on bleomycin-induced lung injury in mice / Respirology 12 : 814 ~ 822
4. [단행본] - Gad SC / 1998 / Acute Toxicology: Principles and Methods. 2nd rev. rev. ed / Academic Press
5. [학술지(정기간행물)] - Dreyer G / 1910 / The blood volume of mammals as determined by experiments upon rabbits, guinea pigs and mice and its relationship to the body weight and to the body surface area expressed as a formula / Phil. Trans. Royal Soc 201 : 1330 ~ 1360
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UCI(KEPA) : I410-ECN-0101-2014-519-000262392