Guidances / guidelines
ICH Guidance, EMA Guideline, FDA Guidance
ICH Guidance (Source https://www.ich.org/)
- Non-Clinical safety studies
- Mutagenic impurities
- Genotoxicity Studies
- Toxicokinetics and Pharmacokinetics
- Toxicity Testing
- Reproductive Toxicology
- Biotechnology Products
- Pharmacology Studies
- Immunotoxicology Studies
- Non Clinical Evaluation of anticancer Pharmaceuticals
- Photo safety
- Non-Clinical pediatric safety
- Development Safety Update Report
- Good Clinical Practices
- Clinical Evaluation of QT
- Pharmacogenetics/ Pharmacogenomics
EMA Guideline ( Source: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines)
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- EMEA guideline on strategies to identify and mitigate risk for FIH
- guideline-non-clinical-studies-required-first-clinical-use-gene-therapy-medicinal-products_
- guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-rev-2_en (1)
- guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-and-submission-reports-suspected-adverse-reactions-medicinal-produ
- guideline-investigation-drug-interactions-revision-1_en
FDA Guidance ( Source FDA https://www.fda.gov/drugs/)
- Estimating-the-Maximum-Safe-Starting-Dose-in-Initial-Clinical-Trials-for-Therapeutics-in-Adult-Healthy-Volunteers
- Drug Interaction Studies Q&A