Sample preparation composite and replicate strategy case studies for assay of solid oral drug products.
J Pharm Biomed Anal
; 146: 59-67, 2017 Nov 30.
Article
en En
| MEDLINE
| ID: mdl-28850864
ABSTRACT
Drug product assay is one of several tests required for new drug products to ensure the quality of the product at release and throughout the life cycle of the product. Drug product assay testing is typically performed by preparing a composite sample of multiple dosage units to obtain an assay value representative of the batch. In some cases replicate composite samples may be prepared and the reportable assay value is the average value of all the replicates. In previously published work by Harrington et al. (2014) [5], a sample preparation composite and replicate strategy for assay was developed to provide a systematic approach which accounts for variability due to the analytical method and dosage form with a standard error of the potency assay criteria based on compendia and regulatory requirements. In this work, this sample preparation composite and replicate strategy for assay is applied to several case studies to demonstrate the utility of this approach and its application at various stages of pharmaceutical drug product development.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Preparaciones Farmacéuticas
Límite:
Humans
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
2017
Tipo del documento:
Article