Analytical Target Profile (ATP) and Method Operable Design Region (MODR)

Author:

Mahr Amanda Guiraldelli,Lourenço Felipe Rebello,Borman Phil,Weitzel Jane,Roussel Jean-Marc

Publisher

Springer International Publishing

Reference40 articles.

1. Guiraldelli A, Weitzel J (2022) Evolution of analytical procedure validation concepts: part I – analytical procedure life cycle and compendial approaches. Pharm Technol

2. USP (2022) USP general chapter <1220> analytical procedure lifecycle

3. Separovic L, Simabukuro RS, Couto AR et al (2021) Measurement uncertainty and conformity assessment applied to drug and medicine analyses – a review. Crit Rev Anal Chem. https://doi.org/10.1080/10408347.2021.1940086

4. Separovic L, Lourenço FR (2020) Frequentist approach for estimation of false decision risks in conformity assessment based on measurement uncertainty of liquid chromatography analytical procedures. J Pharm Biomed Anal

5. Williams A, Magnusson B (eds) (2021) Eurachem/CITAC guide: use of uncertainty information in compliance assessment, 1st edn

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