Sentence examples for validation guidelines from inspiring English sources

This method has been validated to meet FDA validation guidelines.

Many commercially available assays have been already approved by FDA or have been clinically validated in accordance with international approved validation guidelines.

The proposed method was validated according to the ICH Q2 (R1) method validation guidelines.

This fact indicates that the previous TLC-densitometric methods presented in cited previous papers were not validated in term of specificity accordance to validation guidelines [ 33, 34].

It will be necessary to further validate these findings with additional independent cohorts of samples to meet accepted international validation guidelines [ 55].

In this chapter, traditional method validation guidelines and the associated method characteristics are discussed.

An alternative approach, set by the European Medicine Agency (EMA) Guidelines on Process Validation (Guideline on process validation for finished products – information and data to be provided in regulatory submissions & EMA/CHMP/CVMP/QWP/749073/2016.

The advantages of the CoSYPS Path Food screening strategy and the validation guideline are discussed.

Assay validation to meet the acceptance criteria was performed according to the bioanalytical method validation guideline (European Medicines Agency Guideline on Bioanalytical Method Validation, July 21 , 2011.

The limit of quantification was set at 10 ng/mL, according to the bioanalytical validation guideline published by the FDA, acceptable precision and accuracy results were achieved.

The selected parameters were used to develop linear and nonlinear models, and the prediction capability and robustness of the proposed models were studied using internal and external validation methods according to the QSAR method validations guidelines [ 29] and references [ 30– 30].