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Pre-ANDA strategy and Human Factors activities to de-risk pharmaceutical companies ANDA submission of drug-device combination products: case study of a formative Comparative Use Human Factors study.
Brunet-Manquat L, Combedazou A, Ahuja B, Maden A, Ramus C, Mardovina T, Frolet C. Brunet-Manquat L, et al. Among authors: combedazou a. Expert Opin Drug Deliv. 2024 May;21(5):767-778. doi: 10.1080/17425247.2024.2356678. Epub 2024 May 29. Expert Opin Drug Deliv. 2024. PMID: 38753579 Free article.
User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with a staked 8 mm ultra-thin wall needle.
Pager A, Combedazou A, Guerrero K, Tzvetkova-Chevolleau T, Morel D, Frolet C, Glezer S. Pager A, et al. Among authors: combedazou a. Expert Opin Drug Deliv. 2020 Oct;17(10):1485-1498. doi: 10.1080/17425247.2020.1796630. Epub 2020 Aug 9. Expert Opin Drug Deliv. 2020. PMID: 32700596 Free article. Clinical Trial.