1968-1993 年美国食品和药物管理局的生物药剂学历史。
A history of biopharmaceutics in the Food and Drug Administration 1968-1993.
出版信息
AAPS J. 2010 Mar;12(1):44-50. doi: 10.1208/s12248-009-9154-8. Epub 2009 Nov 20.
Abstract
The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions it was to have, and the implementation of that authority are described. The determination of bioequivalence, the bioavailability decision rules, pharmacokinetics, and drug metabolism are explained. The reason for the development of the Scale-Up and Post Approval Regulations and how they were developed are also explained.
摘要
回顾了生物药剂学的历史，从其起源于药物局临床研究司开始。描述了创建生物药剂学司的原因、食品和药物管理局对其将要履行的职能的认证以及该职能的实施。解释了生物等效性的确定、生物利用度决策规则、药代动力学和药物代谢。还解释了制定扩大规模和批准后法规的原因以及如何制定这些法规。
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Scaleup of oral extended-release dosage forms.口服缓释剂型的放大生产
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An evaluation of the absorption characteristics of different chloramphenicol preparations in normal human subjects.不同氯霉素制剂在正常人体受试者中的吸收特性评估。
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Bioavailability of digoxin.地高辛的生物利用度。
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Variation in biologic availability of digoxin from four preparations.四种制剂中地高辛生物利用度的差异。
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Assessment of the biologic availability of tetracycline products in man.四环素类产品在人体中的生物利用度评估。
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Equivalence lack in digoxin plasma levels.地高辛血浆水平缺乏等效性。
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