Results 1 to 10 of about 19 (19)

The New S7B/E14 Q&A Document Provides Additional Opportunities to Replace the Thorough QT Study

Journal of Clinical Pharmacology, 2023
Börje Darpo, Derek J Leishman
exaly  

The New S7B/E14 Question and Answer Draft Guidance for Industry: Contents and Commentary

Journal of Clinical Pharmacology, 2021
Börje Darpo, Georg Ferber
exaly  

Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As

Journal of Pharmacological and Toxicological Methods, 2023
Eric I Rossman, Michael G Rolf, Derek J Leishman   +2 more
exaly  

A novel approach to improve the nutritional value of black gram (Vigna mungo L.) by the combined effect of pre-gelatinization and fermentation by Lactobacillus sp. E14 and Saccharomyces cerevisiae MK-157: Impact on morphological, thermal, and chemical structural properties

LWT - Food Science and Technology, 2022
Syed Arsalan Ali, Syed Muhammad Ghufran Saeed, Uroosa Ejaz   +2 more
exaly  

The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance

British Journal of Pharmacology, 2010
Börje Darpo
exaly  

Clinical Evaluation of QT/QTc Prolongation and Proarrhythmic Potential for Nonantiarrhythmic Drugs: The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 Guideline

Journal of Clinical Pharmacology, 2006
Börje Darpo
exaly  

High-throughput whole-genome sequencing of E14 mouse embryonic stem cells

Genomics Data, 2015
Danny Incarnato, Francesco Neri
exaly  

A new probe for tracking the presence of E141i food colorant

Food Control, 2015
Antonio Pérez-Gálvez, Maria Roca
exaly  

Evaluation of the non-toxic mutant of the diphtheria toxin K51E/E148K as carrier protein for meningococcal vaccines

Vaccine, 2016
Benjamin G Davis
exaly  

ICH E14: A New Regulatory Guidance on the Clinical Evaluation of QT/QTc Internal Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs

Drug Information Journal, 2005
Sager Philip T, Darpo Börje
exaly