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Regulatory Toxicology and Pharmacology : RTP|October 13, 2020
A review of clinical pharmacology deficiencies of European centralised drug marketing authorisation applicationsJustin L Hay, Jane O'Sullivan, Essam Kerwash, et al.
British Journal of Clinical Pharmacology|November 26, 2024
Applying the estimand framework to clinical pharmacology trials with a case study in bioequivalenceHelle Lynggaard, Sue McKendrick, Mark Baird, et al.
Pharmaceuticals (Basel, Switzerland)|January 8, 2025
Exploring the Feasibility of a Bracketing Approach Utilizing Modeling for Development of Long-Acting Injectables for Regulatory Approval-A Case Study Using LevonorgestrelSusan Cole, Henry Pertinez, Andrew S Butler, et al.
Frontiers in Pharmacology|December 16, 2024
Evaluation of mathematical models for predicting medicine distribution into breastmilk - considering biological heterogeneitySumin Heo, Andrew S Butler, Marina Stamouli Simoncioni, et al.
Current Issues in Molecular Biology|August 28, 2024
Regulatory Assessment of Casgevy for the Treatment of Transfusion-Dependent β-Thalassemia and Sickle Cell Disease with Recurrent Vaso-Occlusive CrisesEssam Kerwash, Marija Sajic, Khadija Rerhou Rantell, et al.
Pharmaceutical Research|May 28, 2025
Using Model Master Files to Support Oral Drug Product Development and Regulatory SubmissionsYi-Hsien Cheng, Arindom Pal, Rebecca Moody, et al.
Gates Open Research|July 22, 2024
Demystifying physiologically based pharmacokinetic modelling among non-modelers towards model-informed medicine use in under-served populationsJolien Freriksen, Joyce van der Heijden, Marika de Hoop-Sommen, et al.
CPT: Pharmacometrics & Systems Pharmacology|April 3, 2024
Covariate modeling in pharmacometrics: General points for considerationKinjal Sanghavi, Jakob Ribbing, James A Rogers, et al.
CPT: Pharmacometrics & Systems Pharmacology|June 28, 2017
Commentary on the MID3 Good Practices PaperEfthymios Manolis, Jacob Brogren, Susan Cole, et al.
The Oncologist|February 12, 2020
The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B-Cell LymphomaSahra Ali, Rune Kjeken, Christiane Niederlaender, et al.
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