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Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials

BACKGROUND: In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated its efficacy guideline for good clinical practice and introduced quality tolerance limits (QTLs) as a quality control in clinical trials. Previously, TransCelerate pro...

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Detalles Bibliográficos
Autores principales:	Makowski, Marcin, Bhagat, Ruma, Chevalier, Soazig, Gilbert, Steven A., Görtz, Dagmar R., Kozińska, Marta, Nadolny, Patrick, Suprin, Melissa, Turri, Sabine
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2021
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8492573/ https://www.ncbi.nlm.nih.gov/pubmed/34453269 http://dx.doi.org/10.1007/s43441-021-00335-3

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