Generic Drug Product Development Bioequivalence Issues
نویسندگان
چکیده
منابع مشابه
Scientific Issues in Botanical Drug Product Development
In recent years, as more and more innovative drug products are going off patents, the search for new medicines such as botanical drug products that can treat critical and/or life-threatening diseases has become the center of attention of many pharmaceutical companies and research organizations such as the United States National Institutes of Health (NIH). A botanical drug product is often recog...
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In this study, an open, double-blind, randomized, two-period, two-group crossover design was conducted in 14 healthy volunteers to study the bioequivalence of a fixed-dose generic product. After administration of test or reference products to each volunteer, both active ingredients were determined simultaneously in plasma samples using a developed and validated HPLC-UV method, and pharmacokinet...
متن کاملBioequivalence of generic drugs.
Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy o...
متن کاملAllometric issues in drug development.
The concept of correlating pharmacokinetic parameters with body weight from different animal species has become a useful tool in drug development. The allometric approach is based on the power function, where the body weight of the species is plotted against the pharmacokinetic parameter(s) of interest. Clearance, volume of distribution, and elimination half-life are the three most frequently e...
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ژورنال
عنوان ژورنال: Journal of Pharmacy & Pharmaceutical Sciences
سال: 2008
ISSN: 1482-1826,1482-1826
DOI: 10.18433/j3001b