https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/policy-pharmacometrics-drug-submissions-clinical-trials-applications.html
Pharmacometric approaches play an increasing role in developing drug submissions and clinical trial applications (CTAs). Find out what sponsors should consider.
policy statementusepharmacometricsdrugsubmissions
https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
clinical trial applicationscommon issuesgov ukidentified