This post is an excerpt from ‘Current Challenges and Advancements in Residue Analytical Methods‘. Pragmatism in Method Design There are many components necessary to undertaking analytical chemistry work and method design. One of the most important of these is to approach each analytical obstacle with pragmatism. Being pragmatic is “dealing with things sensibly and realistically […]
This post is an excerpt from ‘Current Challenges and Advancements in Residue Analytical Methods‘.
Pragmatism in Method Design
There are many components necessary to undertaking analytical chemistry work and method design. One of the most important of these is to approach each analytical obstacle with pragmatism. Being pragmatic is “dealing with things sensibly and realistically in a way that is based on practical rather than theoretical considerations.” It is essential to approach method development and design with pragmatism because analytical chemists are faced with the task of solving difficult problems. Whether chemists are just starting their careers or have a considerable amount of experience, there are a large number of tools and information at their disposal. Theoretically supported decisions are routinely made during method development and are understood through the lens of well-known chemistry concepts. Practicality, however, largely depends on the experience of the chemist surrounding the specific type of analytical challenge. Because each novel problem may require a unique approach, the amount of background practice with each problem type may be lacking. As a result, oftentimes chemists over rely on the theoretical underpinnings of their experience and use the most complex solutions to solve troublesome problems. Instead, the most elegant solution to a difficult problem is often the most concise, the most direct, the simplest.
What Is Method Design versus Development?
Method development can be considered as the steps taken to generate a preliminary method. Although the discussion here focuses on method development and design through the scope of development of residue analytical methods (specifically for small molecules), these concepts are applicable to a wide scope of different types of method development. The resulting preliminary residue analytical method produced from method development may already meet many analytical acceptance criteria typically assessed during method validation. However, addressing elements of method design adds a different set of acceptance criteria, taking into consideration the practicality of the method. This addition of extra criteria shifts the focus to encompass not only a standard that defines the acceptance of the data (e.g., accuracy and precision) but also the suitability or acceptance of the method of obtaining the data (e.g., sample throughput).
The pharmaceutical industry has a well-developed set of method validation acceptance criteria. An exhaustive amount of regulatory guidelines have been put forth to ensure the generation of accurate and precise data to support the safe use of pharmaceuticals. This is both beneficial and prohibitory. From the agrochemical perspective, thorough guidelines addressing each individual aspect of method validation criteria are helpful, because the goal is to produce the best data possible and support the safe use of pesticides. However, if the agrochemical industry guidelines for residue analytical methods were as exhaustive as the pharmaceutical guidelines, the agility now possible in method development and design would likely be diminished. In addition, pharmaceutical method development and design largely focus on a small subset of matrix types, whereas agrochemical methods may cover matrix types from head lettuce to tobacco, and laminate flooring to insects as food. Due to the wide abundance of guidelines for the pharmaceutical industry, and the resulting discussion in literature, many of the ideas discussed herein are shared from pharmaceutical industry discussions. Just as the concepts of small molecule analysis can be applied to bioanalytical method validation and protein analysis, concepts from the pharmaceutical industry can be related for use in method development and design.
Editors: Elisabeth A. Schoenau, Tao Geng, Ryan Hill, Norma L. Houston, Manasi Saha, Xiao Zhou
Publication Date (Web): March 28, 2019
Copyright ©2019 American Chemical Society
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