Risk of false pharmaceutical equivalence (non-equivalence) decisions due to measurement uncertainty (2021)
- Authors:
- USP affiliated authors: LOURENÇO, FELIPE REBELLO - FCF ; BERTANHA, MARIA LUIZA DE GODOY - FCF
- Unidade: FCF
- DOI: 10.1016/j.jpba.2021.114269
- Subjects: MEDICAMENTO; MEDIÇÃO DE RISCO; BIOEQUIVALÊNCIA; QUALIDADE DOS MEDICAMENTOS
- Agências de fomento:
- Language: Inglês
- Imprenta:
- Source:
- Título: Journal of Pharmaceutical and Biomedical Analysis
- ISSN: 0731-7085
- Volume/Número/Paginação/Ano: v. 204, p. 1-9 art. 114269, 2021
- Status:
- Nenhuma versão em acesso aberto identificada
-
ABNT
BERTANHA, Maria Luiza de Godoy e LOURENÇO, Felipe Rebello. Risk of false pharmaceutical equivalence (non-equivalence) decisions due to measurement uncertainty. Journal of Pharmaceutical and Biomedical Analysis, v. 204, p. 1-9 art. 114269, 2021Tradução . . Disponível em: https://doi.org/10.1016/j.jpba.2021.114269. Acesso em: 10 abr. 2026. -
APA
Bertanha, M. L. de G., & Lourenço, F. R. (2021). Risk of false pharmaceutical equivalence (non-equivalence) decisions due to measurement uncertainty. Journal of Pharmaceutical and Biomedical Analysis, 204, 1-9 art. 114269. doi:10.1016/j.jpba.2021.114269 -
NLM
Bertanha ML de G, Lourenço FR. Risk of false pharmaceutical equivalence (non-equivalence) decisions due to measurement uncertainty [Internet]. Journal of Pharmaceutical and Biomedical Analysis. 2021 ; 204 1-9 art. 114269.[citado 2026 abr. 10 ] Available from: https://doi.org/10.1016/j.jpba.2021.114269 -
Vancouver
Bertanha ML de G, Lourenço FR. Risk of false pharmaceutical equivalence (non-equivalence) decisions due to measurement uncertainty [Internet]. Journal of Pharmaceutical and Biomedical Analysis. 2021 ; 204 1-9 art. 114269.[citado 2026 abr. 10 ] Available from: https://doi.org/10.1016/j.jpba.2021.114269 - Total combined risk of false conformity decisions in pharmaceutical equivalence of acetaminophen oral solution
- Impact of metrological correlation on the total combined risk in pharmaceutical equivalence evaluations
- Risk of false decisions in chromatographic and spectrometric identification of chemical compounds
- Setting multivariate and correlated acceptance limits for assessing the conformity of items
- Frequentist approach for estimation of false decision risks in conformity assessment based on measurement uncertainty of liquid chromatography analytical procedures
- Application of measurement uncertainty on conformity assessment in pharmaceutical drug products
- Top-down evaluation of the matrix effects in microbial enumeration test uncertainty
- Development and optimization of a stability-indicating chromatographic method for verapamil hydrochloride and its impurities in tablets using an analytical quality by design (AQbD) approach
- Reduced incubation time for inhibition zone formation based on diffusion and growth mechanism elucidation
- Measurement uncertainty in pharmaceutical analysis and its application
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