Cargando…

Sample Size Determination for Individual Bioequivalence Inference

Statistical criterion for evaluation of individual bioequivalence (IBE) between generic and innovative products often involves a function of the second moments of normal distributions. Under replicated crossover designs, the aggregate criterion for IBE proposed by the guidance of the U.S. Food and D...

Descripción completa

Detalles Bibliográficos
Autores principales:	Chiang, Chieh, Hsiao, Chin-Fu, Liu, Jen-Pei
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Public Library of Science 2014
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4195669/ https://www.ncbi.nlm.nih.gov/pubmed/25310592 http://dx.doi.org/10.1371/journal.pone.0109746

Ejemplares similares

Adaptive two-stage bioequivalence trials with early stopping and sample size re-estimation
por: Koenig, Franz, et al.
Publicado: (2015)

Sample size determination for a specific region in multiregional clinical trials with multiple co-primary endpoints
por: Huang, Wong-Shian, et al.
Publicado: (2017)

Determination of Actarit from Human Plasma for Bioequivalence Studies
por: Loya, P., et al.
Publicado: (2010)

Evaluation of model‐based bioequivalence approach for single sample pharmacokinetic studies
por: Tardivon, Coralie, et al.
Publicado: (2023)

Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products
por: Pensado, A., et al.
Publicado: (2019)

Effect of Study Design on Sample Size in Studies Intended to Evaluate Bioequivalence of Inhaled Short‐Acting β‐Agonist Formulations
por: Zeng, Yaohui, et al.
Publicado: (2017)

A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies
por: Chung, Inbum, et al.
Publicado: (2018)

A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies
por: Chung, Inbum, et al.
Publicado: (2017)

Evaluation of pharmacokinetics and safety with bioequivalence of Amlodipine in healthy Chinese volunteers: Bioequivalence Study Findings
por: Wang, Tongtong, et al.
Publicado: (2020)

Effects of size and surface of zinc oxide and aluminum-doped zinc oxide nanoparticles on cell viability inferred by proteomic analyses
por: Pan, Chih-Hong, et al.
Publicado: (2014)

Sampling times and genotyping concerns in bioequivalence evaluation of branded and generic formulations
por: Zhao, Xiao-Ying, et al.
Publicado: (2013)

Assessing the Effect of Sequencing Depth and Sample Size in Population Genetics Inferences
por: Fumagalli, Matteo
Publicado: (2013)

Bioequivalence: tried and tested
por: Schall, Robert, et al.
Publicado: (2010)

Bioequivalence studies in Morocco
por: Zaoui, Sanaa, et al.
Publicado: (2020)

Bioequivalence data analysis
por: Park, Gowooni, et al.
Publicado: (2020)

Sample-size determination
por: Mace, Arthur E.
Publicado: (1964)

Size-reduced fexuprazan 20 mg demonstrated the optimal bioavailability and bioequivalence with the reference formulation
por: Yang, A-Young, et al.
Publicado: (2023)

Tolerance interval testing for assessing accuracy and precision simultaneously
por: Chiang, Chieh, et al.
Publicado: (2021)

Sample size determination for training set optimization in genomic prediction
por: Wu, Po-Ya, et al.
Publicado: (2023)

Constrained statistical inference: sample-size tables for ANOVA and regression
por: Vanbrabant, Leonard, et al.
Publicado: (2015)

Non-Invasive Multiparametric Approach To Determine Sweat–Blood Lactate Bioequivalence
por: Rabost-Garcia, Genis, et al.
Publicado: (2023)

Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets
por: Brioschi, Tatiane Maria de Lima Souza, et al.
Publicado: (2013)

Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Vardenafil and Its Application of Bioequivalence
por: Gan, Kok Zheng, et al.
Publicado: (2021)

Retraction and Republication: A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies
por: Chung, Inbum, et al.
Publicado: (2018)

Between-Batch Bioequivalence (BBE): a Statistical Test to Evaluate In Vitro Bioequivalence Considering the Between-Batch Variability
por: Bodin, Jonathan, et al.
Publicado: (2020)

RNA-seq preprocessing and sample size considerations for gene network inference
por: Altay, Gökmen, et al.
Publicado: (2023)

Inferring the Temporal Order of Cancer Gene Mutations in Individual Tumor Samples
por: Guo, Jun, et al.
Publicado: (2014)

Bioequivalence assessment of two formulations of ibuprofen
por: Al-Talla, Zeyad A, et al.
Publicado: (2011)

Sample size determination and power
por: Ryan, Thomas P, Jr
Publicado: (2013)

Sample size determination for Bayesian ANOVAs with informative hypotheses
por: Fu, Qianrao, et al.
Publicado: (2022)

Sample size determination for mediation analysis of longitudinal data
por: Pan, Haitao, et al.
Publicado: (2018)

SWEET: a single-sample network inference method for deciphering individual features in disease
por: Chen, Hsin-Hua, et al.
Publicado: (2023)

Sample size determination for bibliographic retrieval studies
por: Yao, Xiaomei, et al.
Publicado: (2008)

Sample size determination with a pilot study
por: O’Neill, Ben
Publicado: (2022)

Evaluation of the Bioequivalence of Acarbose in Healthy Chinese People
por: Chen, Yan, et al.
Publicado: (2021)

Bioequivalence of Ertugliflozin/Sitagliptin Fixed‐Dose Combination Tablets and Coadministration of Respective Strengths of Individual Components
por: Fediuk, Daryl J., et al.
Publicado: (2019)

Bioequivalence of Ertugliflozin/Metformin Fixed‐Dose Combination Tablets and Coadministration of Respective Strengths of Individual Components
por: Dawra, Vikas Kumar, et al.
Publicado: (2019)

Focus on biosimilar etanercept – bioequivalence and interchangeability
por: Cantini, Fabrizio, et al.
Publicado: (2018)

The Case for Standardizing the Appearance of Bioequivalent Medications
por: Engelberg, Alfred B.
Publicado: (2011)

A normative inference approach for optimal sample sizes in decisions from experience
por: Ostwald, Dirk, et al.
Publicado: (2015)

Cannot write session to /tmp/vufind_sessions/sess_bkfovv5oi1v1iov0410li5aksq