A Preliminary Study on Statistical Evaluation of Genetically Modified Products
Date Issued
2007
Date
2007
Author(s)
Yang, Kong-Chung
DOI
en-US
Abstract
Genetic modified (GM) products are defined as the genetic modified plants (crops) and their derived feed or food. The cultivated area of GM crops has increased from 1.7 million hectares in 1996 to 100 million hectares in 2006. There are already 11 GM crops on the market including corn, soybean, cotton, canola, rice, squash, papaya, sugar beet, potato and tomato. In addition, in 2006, there are 96 commercial GM products for member states of Organization of Economic and Cooperation Development (OECD). The current worldwide market for GM products is US $6.2 billions with a double digit growth rate and the GM products also account about 25% of commercial seed market. Therefore, trend of GM products seems irreversible. As a result, the current focus is the effective management and adequate regulations to ensure that GM products are safe to grow and to consume.
In this preliminary study, we will first review the regulations of GM products of the U.S.A., European Union (EU), Japan and Taiwan. Then we introduce the concept of substantial equivalence for approval of GM products which is defined as the no meaningful difference between the GM products and their conventional counterpart. This implies that the GM products are equivalent to the conventional counterpart with respect to phenotypic, agronomic, and compositional parameters, in other word, the entire biochemical profiles.
Not until recently, the principle of average bioequivalence (ABE) for approval of generic drugs is applied to evaluation of substantial equivalence for approval of GM products. However, generic drugs are intended to be used in a small population of patients with one or two active ingredients to compare. On the other hand, GM products are to be consumed by a much larger population of healthy people with up to 100 nutritional, safeties, and other characteristics under investigation. Therefore, in this research, we conduct a preliminary study on feasibility and issues concerning about the application of tolerance intervals to evaluation of substantial equivalence for GM products. The issues considered are the probability content of the tolerance interval, determination of equivalence limits, design of the study, the sample size, and variability due to season and location. On the other hand, the concept of substantial equivalence also suggests that the biochemical profiles of the GM products fall within the range of natural variation established by the biochemical profiles of the conventional counterpart. This implies that the distribution of the biochemical profiles of the GM products is equivalent to that of the conventional products. This concept is referred to as population bioequivalence (PBE). When the distributions approximately follow a normal distribution, the PBE can be established as showing equivalence in both mean and variance. In our research, we also investigate the possible equivalence limits for both mean and variance. Published data are employed to illustrate the proposed procedures.
Subjects
基因改造產品
實質等同
平均生體相等性
容忍區間
族群生體相等性
Genetically modified products
Substantial equivalence
Average bioequivalence
Tolerance interval
Population bioequivalence
Type
thesis
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