Direct spectrofluorimetric methods as alternatives to compendial ones used for the quality control of biopharmaceuticals: development, validation and application
Author:
Affiliation:
1. Oswaldo Cruz Foundation, Brazil
2. Oswaldo Cruz Foundation, Brazil; GlaxoSmithKline, Brazil
Publisher
FapUNIFESP (SciELO)
Link
http://www.scielo.br/scielo.php?script=sci_pdf&pid=S1984-82502024000100301&tlng=en
Reference40 articles.
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2. Resolução nº. 166, de 24 de julho de 2017. Regulamento técnico para Validação de métodos analíticos;Diário Oficial da União,2017
3. Critical approach to synchronous spectrofluorimetry;Andrade-Eiroa A;I. TrAC Trends Anal Chem,2010
4. Poly(hydrophobic amino acid)-Based Self-Adjuvanting Nanoparticles for Group A Streptococcus Vaccine Delivery;Azuar A;J Med Chem,2021
5. Guia para tratamento estatístico da validação analítica;Guia,2017
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