The New S7B/E14 Question and Answer Draft Guidance for Industry: Contents and Commentary.

Darpo, Borje; Ferber, Georg

Darpo, Borje; Ferber, Georg.

Affiliation

Darpo B; Cardiac Safety, ERT, Rochester, New York, USA.
Ferber G; Cardiology, Karolinska Institute, Stockholm, Sweden.

J Clin Pharmacol ; 61(10): 1261-1273, 2021 10.

Article in En | MEDLINE | ID: mdl-33896027

Subject(s)

Drug Approval/organization & administration; Drugs, Investigational/adverse effects; Electrocardiography/standards; Clinical Trials as Topic/standards; Drug Evaluation, Preclinical/standards; European Union; Humans; Models, Biological; United States; United States Food and Drug Administration/standards

Key words

ICH E14; ICH S7B; QTc; QTc prolongation; arrhythmias; cardiology; regulatory

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Full text: 1 Database: MEDLINE Main subject: Drugs, Investigational / Drug Approval / Electrocardiography Type of study: Clinical_trials / Guideline / Prognostic_studies Country/Region as subject: America do norte Language: En Journal: J Clin Pharmacol Year: 2021 Type: Article Affiliation country: United States

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