Analytical Method Performance Evaluation (AMPE)A Software Tool for Analytical Method Validation

Analytical Method Validation for Biopharmaceuticals

Analytical Method Validation

In pharmaceutical industries, the validation of analytical methods is used to demonstrate that the method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good ...

Tributyltin in Crustacean Tissues: Analytical Performance and Validation of Method

O ermitão Clibanarius vittatus é um organismo típico de regiões intertidais estuarinas sendo considerado um possível bioindicador da presença de tributilestanho (TBT) nesses ambientes. Por esta razão, este estudo apresenta o desempenho analítico e a validação do método para quantificação de TBT em tecidos de C. vittatus por cromatografia gasosa com detector fotométrico de chama pulsante (GC-PFP...

Evaluation and Application of Best Practice in Analytical Method Validation

Analytical Method Validation: An Updated Review

The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in a marketing approval. The objective of this paper is to review the method development, optimize and validation of the method for the drug product from the developmental stage of the formulation to commercial batch of the product. Method d...