Global Research and Development, Abbott Laboratories, 200 Abbott Park Road, Abbott Park, Illinois 60064-6198, USA.
Appl Spectrosc. 2010 May;64(5):537-42. doi: 10.1366/000370210791211655.
With the changing development paradigms in the pharmaceutical industry, laboratories are challenged to release materials for clinical studies with rapid turnaround times. To minimize cost demands, many businesses are looking to develop ways of using early Good Manufacturing Practice (GMP) materials of active pharmaceutical ingredients (API) for Good Laboratory Practice (GLP) toxicology studies. To make this happen, the analytical laboratory releases the material by one of three scenarios: (1) holding the GLP release until full GMP testing is ready, (2) issuing a separate lot number for a portion of the GMP material and releasing the material for GLP use, or (3) releasing the lot of material for GLP using alternate (equivalent) method(s) not specified for GMP release testing. Many companies are finding the third scenario to be advantageous in terms of cost and efficiency through the use of quantitative nuclear magnetic resonance (q-NMR). The use of q-NMR has proved to be a single-point replacement for routine early development testing that previously combined elements of identity testing, chromatographic assay, moisture analysis, residual solvent analysis, and elemental analysis. This study highlights that q-NMR can be validated to meet current regulatory analytical method guidelines for routine pharmaceutical analysis.
随着制药行业发展模式的变化，实验室面临着在短时间内发布用于临床研究的材料的挑战。为了降低成本需求，许多企业都在寻求利用活性药物成分 (API) 的早期良好生产规范 (GMP) 材料进行良好实验室规范 (GLP) 毒理学研究的方法。为了实现这一目标，分析实验室通过以下三种方案之一发布材料：(1) 在完成全面 GMP 测试之前保留 GLP 放行，(2) 为 GMP 材料的一部分分配单独的批号并放行用于 GLP 使用的材料，或 (3) 使用未指定用于 GMP 放行测试的替代 (等效) 方法对该批材料进行 GLP 放行。许多公司发现，通过使用定量核磁共振 (q-NMR)，第三种方案在成本和效率方面具有优势。q-NMR 的使用已被证明是对以前结合身份测试、色谱分析、水分分析、残留溶剂分析和元素分析等元素的早期开发测试的单点替代方法。本研究强调，q-NMR 可以经过验证，以满足常规药物分析的当前监管分析方法指南的要求。
