Sentence examples for method transfer and from inspiring English sources
The life cycle of an analytical method consists of design, development, validation (including instrumental qualification, continuous method performance verification and method transfer) and finally retirement of the method.
The FDA accuracy criterion (±15%) without an allowance for imprecision may be used for method transfer and may result in a large numbers of method transfers being judged unacceptable when the method is valid under both conditions.
In addition, topics such as characterization and analysis of biopharmaceutical proteins, solid-state studies, degradation studies, novel dosage forms, preformulation and early-phase method development, in-process control testing, validation of analytical test methods, stability studies, analytical method transfer, and the importance of pharmaceutical analysis documentation are discussed.
Joint conclusion reveals the need for improved education in method transfer and adaptions of the design methods to user-specific needs and paved the way for a series of experiments with various treatments of study participants regarding different personalized adaptions in design methods.
Change of manufacturing site where PAT transfer may be challenging due to instrument availability, need for equipment retrofit, method transfer, and cost.
Finally, HPLC to UHPLC method transfer is discussed and progress in two-dimensional ultra-high-pressure LC is highlighted.
Robust HPLC separations lead to fewer analysis failures and better method transfer as well as providing an assurance of quality.
The observed relative RT of the original and transferred methods are not statistically different and thus the method transfer is successfully achieved thanks to the robust optimization strategy.
and the manual method of transfer and lift.
We could show that the different data gathering methods "benefit transfer" and "expert-based assessment" have a considerable impact on the evaluation outcomes.
The origin and chemical nature of potential migrants, the methods of transfer, and principles involved in development of safety criteria for their regulation are discussed.
