Issue 24 — Shortening Drug Development with Asian Ethnobridging by The Altascientist published on 2022-06-27T15:49:40Z Conducting ethnobridging studies locally, during Phase I, in the target population, can reduce drug development timelines by the number of years typically needed to complete clinical development in the target region, as compared with North America or Europe. A Phase I ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases II and III) without repeating Phase I development in that region and population. Click here to download a readable, PDF version of Issue 24: https://www.altasciences.com/sites/default/files/2022-06/The-Altascientist_issue-24_Ethnobridging.pdf CHAPTERS: - 0:15 — Section 1: Introduction - 1:15 — Section 2: Why Asian Ethnobridging? - 4:22 — Section 3: The ICH E5 Guidance - 5:34 — Section 4: The ICH E7 Guidance - 7:48 — Section 5: Accelerating Asian Drug Development - 10:32 — Section 6: Language Requirements for Global Clinical Trials - 11:09 — Section 7: Altasciences' Expertise and Experience with Ethnobridging About Altasciences: Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. Genre Science