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Diurnal variation in DLCO and non-standardized study procedures may cause a false positive safety signal in clinical trials.
Kirla, Krishna Tulasi; Nemes, Szilárd; Betts, Joanne; Kristensson, Cecilia; Mo, John; Asimus, Sara; Sadiq, Muhammad Waqas; Redlich, Elke; Koernicke, Thomas; Fuhr, Rainard; Brailsford, Wayne; Keen, Christina; Hagberg, Anette; Mäenpää, Jukka.
Afiliação
  • Kirla KT; Patient Safety, Respiratory & Immunology, Chief Medical Office, R&D, AstraZeneca, Gothenburg, Sweden.
  • Nemes S; Early Biostats & Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Betts J; Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Kristensson C; Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Mo J; Patient Safety, Respiratory & Immunology, Chief Medical Office, R&D, AstraZeneca, Gothenburg, Sweden.
  • Asimus S; Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Sadiq MW; Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.
  • Redlich E; Parexel Early Phase Clinical Unit, Berlin, Germany.
  • Koernicke T; Parexel Early Phase Clinical Unit, Berlin, Germany.
  • Fuhr R; Parexel Early Phase Clinical Unit, Berlin, Germany.
  • Brailsford W; Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Keen C; Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Hagberg A; Patient Safety, Respiratory & Immunology, Chief Medical Office, R&D, AstraZeneca, Gothenburg, Sweden.
  • Mäenpää J; Patient Safety, Respiratory & Immunology, Chief Medical Office, R&D, AstraZeneca, Gothenburg, Sweden. Electronic address: jukka.maenpaa@astrazeneca.com.
Respir Med ; 191: 106705, 2022 01.
Article em En | MEDLINE | ID: mdl-34879298

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article