Write Your Science Right・研究を世界に届ける文章力
第10回 Analytical Method Validation in Research: How to Avoid Irreproducible Results and Retractions
In building a research career, especially in the hard sciences and engineering-related fields, before actual research can be conducted, a strategy is needed for data collection, and this strategy forms the research methods. This is important to ensure that the results obtained are repeatable, reproducible, and can be validated using standard methods. Since most research involves some form of analytical method, most of it ultimately relies on collecting usable and valid analytical data.
Analytical Method Validation
Analytical method validation (AMV) is the process of coming up with a final, optimized method that meets the standard requirements of a universally accepted organization. AMV considers many criteria like repeatability, reproducibility, robustness, ruggedness, system suitability, limits of detection, and limits of quantitation, and can vary across industries and research fields.
Several organizations exist that provide criteria to determine what is a validated method, and numerous books, journals, review papers, magazines, and websites are devoted to discussions on AMV. Typically, the resources that guide AMV tend to focus on pharmaceutical fields. However, AMV can guide research in every field unofficially. Indeed, researchers should be aware of these basic, fundamental guidelines in order to conduct an AMV of their own methods before submitting a manuscript to a journal, even if scientific journals don’t strictly require them for manuscript submissions.
Here are a few of the basic guidelines for conducting AMV by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
1. Repeatability and reproducibility
表紙
機構模型
工部大学校の「機械学」教育機器(機械遺産第100号)
回転斜板
年代未詳/フォイト社製/ベルリン(独)/真鍮、鉄、ガラス、木製台座/
H220, W320, D145(mm)/東京大学総合研究博物館所蔵
ハンドルに「GUSTAV VOIGT BERLIN. S. W.」の刻字あり。工科大学もしくは工学部の備品番号「工キ學ニ四九八」の木札付。本模型の年代は未詳であるが、東京大学総合研究博物館には工部大学校を示すプレート付きのものを含め、近代的な機械学教育のために明治期以降に導入された機構模型が現存する。
上野則宏撮影/東京大学総合研究博物館写真提供/インターメディアテク展示・収蔵
[東京大学総合研究博物館]