第1階段:方法設計與開發

定義分析目標資料(ATP),證明方法的效能特性符合規定條件,同時思考整個量測方面的不確定因素,為第1階段做準備。藉由「品質源於設計」(QbD)概念深入認識影響方法效能的因素,這樣能幫助您從一開始就確保優異的方法穩定性。

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深入瞭解設計與開發

Videos / Webinars
Developing impurities analytical methods with a quality by design approach
Developing impurities analytical methods with a quality by design approach

The presence of impurities, even at trace levels, may affect the quality, safety and efficacy of drug products. Impurities in a drug substance or drug product can arise from chemical synthesis, degradation, manufacturing, storage conditions, packaging, excipients or contamination. Analytical method development for impurity detection and quantitation is a necessary and often challenging task for pharmaceutical manufacturers. Risk-based approaches such as Analytical Quality by Design (AQbD) and Method Lifecycle Management (MLCM) can be implemented to develop fit-for-purpose and robust methods that improve the control of impurities.

應用手冊/技術簡報
運用Empower 3 CDS軟體加強方法開發階段的決策能力
加強方法開發階段的決策能力

減少變數來源對於MLCM流程至關重要。Empower運算報告讓使用者可以根據指數選擇最好的方法條件,而不是仰賴個人判斷。運算報告可以讓使用者快速找出符合既定標準(ATP)的條件—能消除分析人員在方法開發過程中造成的變數與偏見。本技術簡報介紹Empower 3軟體使用自訂計算與自訂報告運算層析分離處理分數的功能。

Podcast
Podcast Series Episode 7: Data-driven Modeling Approaches to Improve Method Development

Pfizer's Dr. Pankaj Aggarwal discusses the use of data-driven modeling to build quality and robustness into analytical methods.

Videos / Webinars
Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach

Applying Quality-by-Design approaches to analytical method development has many benefits. It emphasizes the identification of the sources of variability and their impact on method performance.

Analytical Quality-by-Design Based Method Development for the Analysis of Formoterol, Budesonide, and Related Compounds Using UHPLC-MS

Analytical methods are required to be developed at different stages of the pharmaceutical product life cycle. Two of the most widely used strategies for method development are: one-factor-at-a-time (OFAT) and analytical quality-by-design approach (AQbD).

Blogs / Articles
Modern Perspectives on Method Development: An Interview with Dr. Fadi Alkhateeb

Dr. Fadi Alkhateeb of Waters Corporation discusses his recent method development work.

What does it mean to develop a good LC method?

With Method Lifecycle Management (MLCM) we focus not only on the quality of the analytical method but also on the quality of the reportable result. The goal is to generate quality data across the life of a method.

App notes / Tech briefs
Automated Peak Tracking Using Mass Detection and Fusion QbD Software

Tracking peaks across different chromatograms in the method development process can be challenging. This is because sample components could shift, switch retention times, or even coeleute under different separation conditions. Many method development protocols rely on ultra violet (UV) spectral data only to track peaks. Despite the potential benefits of such protocols they can still have some limitations.

App notes / Tech briefs
BEH C18 Batch-to-Batch Robustness for the Analysis of Rosuvastatin

The goal of a method development process is to find a well-working and robust method that consistently delivers the expected performance throughout its lifecycle. This process can be very complex and time-consuming, especially if multiple chromatographic parameters need to be explored.

Blogs / Articles
Modern Tools and Risk-Based Method Development Strategies Pave the Way for a New Generation of Analytical Methods

In the pharmaceutical industry there’s a shift and it’s changing the way we think about and develop analytical methods. Change can be uncomfortable, but when the driving forces are to ensure data quality, make better decisions and improve patient outcomes, how can we resist?

影片/網路研討會
運用ACQUITY QDa質譜偵測器在方法開發階段進行UV正交偵測
提升方法理解度/品質的現代技術

Waters的Paula Hong說明如何在方法開發階段運用ACQUITY QDa質譜偵測器進行UV正交偵測。

影片/網路研討會
使用UPLC結合ACQUITY QDa質譜偵測器與AutoBlend Plus技術為不純物分析進行方法開發
提升方法理解度/品質的現代技術

採用ACQUITY QDa質譜偵測器時,無需使用標準品的滯留時間確認訊號峰,因此有助於提高方法開發的效率和穩定性。在這段影片中,我們示範在方法開發中使用定性質譜數據,運用ACQUITY QDa質譜偵測器識別齊拉西酮HCl及相關化合物。

應用手冊/技術簡報
在LC方法開發中執行系統篩檢流程的完整解決方案
兼具穩定性並能夠加快上市速度的系統化方法開發

本白皮書說明一項具有增效作用且精簡的系統化方法開發方式,這項方式會運用UPLC儀器、sub-2-μm管柱化學材料以及Empower 3軟體。

應用手冊/技術簡報
USP方法案例研究第I部分:瞭解樣品製備與移動相穩定性的影響
瞭解方法條件

下面的研究審慎評估阿托伐他汀的USP化驗。為盡可能降低環境條件的影響,一律採用USP第621章容許範圍內的方式控管樣品製備與移動相成分。這些研究讓科學人員能夠調整策略,盡可能避免在諸多跨國實驗室之間轉移USP方法時出現變化。

應用手冊/技術簡報
為藥品穩定性調查開發分析級層析方法
運用AQbD進行方法開發

本應用手冊說明一項案例研究,這項研究採用「品質源於設計」(QbD)方法,開發出能表示穩定性的分析方法,以利監控口服懸液專用阿莫西林粉末的降解情形。內容說明QbD如何運用Fusion QbD軟體選擇係數值組合、建立採集方法,以及評估符合模式的訊號值。