Estimation of a Suitable Number of Patients for Selective Safety Data Collection (ICH E19 Draft Guideline): When is the Safety Profile of a Drug Well Characterized?

Saeki, Hiroyuki; Komeda, Takuji; Tanaka, Risa; Yamatani, Yuki; Sakai, Hironori

Saeki, Hiroyuki; Komeda, Takuji; Tanaka, Risa; Yamatani, Yuki; Sakai, Hironori.

Afiliação

Saeki H; Data Science Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan. hiroyuki.saeki@fujifilm.com.
Komeda T; FUJIFILM Toyama Chemical Co., Ltd., 2-14-1 Kyobashi, Chuo-ku, Tokyo, 104-0031, Japan. hiroyuki.saeki@fujifilm.com.
Tanaka R; Data Science Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
Yamatani Y; Shionogi & Co., Ltd., Osaka, Japan.
Sakai H; Data Science Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.

Ther Innov Regul Sci ; 56(4): 587-595, 2022 07.

Article em En | MEDLINE | ID: mdl-35355238

Assuntos

Panitumumabe; Simulação por Computador; Humanos; Incidência; Método de Monte Carlo; Probabilidade

Palavras-chave

Half-width of two-sided 95% confidence interval; Incidence rate; Risk difference; Selective safety data collection; Simulation; Suitable number of patients

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Contexto em Saúde: 1_ASSA2030 Problema de saúde: 1_financiamento_saude Assunto principal: Panitumumabe Tipo de estudo: Guideline / Health_economic_evaluation / Incidence_studies / Prognostic_studies Limite: Humans Idioma: En Revista: Ther Innov Regul Sci Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Japão

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