Resources
Regulatory authorities and quidelines
- EMA (European Medicines Agency) Homepage Non-clinical scientific guidelines
- US-FDA (U.S. Food and Drug Administration) www.fda.gov Investigational New Drug (IND) Application Estimating the Maximum Safe Starting Dose in Initial Clinical Trials
- Swissmedic www.swissmedic.ch
- PEI (Paul-Ehrlich-Institut) www.pei.de
- MHRA (UK) www.gov.uk/mhra
- PMDA (Japan) www.pmda.go.jp/english
- Health Canada www.canada.ca/en/health-canada
- TGA (Australia) www.tga.gov.au
ICH (International Council for Harmonisation) www.ich.org Safety guidelines (S-series) Multidisciplinary guidelines (M-series) Quality guidelines (Q-series) Efficacy guidelines (E-series)
Alternative methods / NAMS (New Approach Methodologies)
- NIH ICCVAM — US interagency committee on alternative test methods ntp.niehs.nih.gov/iccvam
- FDA — Advancing Alternative Methods fda.gov/advancing-alternative-methods
- NC3Rs (UK) — National Centre for the 3Rs nc3rs.org.uk
- EURL ECVAM (EU) — EU Reference Laboratory for Alternatives to Animal Testing EURL ECVAM homepage
Clinical trials
- WHO ICTRP — meta-registry aggregating national registries worldwide
- Home | ClinicalTrials.gov (US)
- Clinical Trials Register (European)
- Chinese Clinical Trial Register (ChiCTR) - The world health organization
- international clinical trials registered organization registered platform
臨床研究等提出・公開システム (niph.go.jp) - CTRI (India)
- ANZCTR (Australia/New Zealand)
Other useful databases
- PatSnap — patent data, analytics
- Espacenet — patent search (Europe)
- USPTO Patent Public Search (USA)
- PubMed — biomedical literature
- FDA Orange Book — approved drug products & therapeutic equivalence
- EMA EPAR database — European Public Assessment Reports