Guidances / guidelines
ICH Guidance, EMA Guideline, FDA Guidance
ICH Guidance (Source https://www.ich.org/)
- Non-Clinical safety studies
- Virus and Gene therapy Vector
- Mutagenic impurities
- Drug Interaction Studies
- 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
- Non Clinical Biodistribution for gene therapy:
- Non Clinical Safety Studies for Oligonucleotide based Therapeutics
- Clinical Safety Data Management
- Development Safety Update Report
- Good Clinical Practices
- General Considerations
- Clinical Investigations
- Clinical Evaluation of QT
- Pharmacogenetics/ Pharmacogenomics
- E20 Adaptative designs
EMA Guideline ( Source: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines)
- 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-prod
- guideline-investigation-drug-interactions-revision-1_en
- Clinical Trials Facilitation and Coordination Group (CTFG): Recommendations Related to Contraception and Pregnancy Testing in Clinical Trials trpguidancereproriskfinal
FDA Guidance ( Source FDA https://www.fda.gov/drugs/)
- Guidance for Industry. Format and Content of a REMS OP_REMS final
- Guidance for Industry: Safety Testing of Drug Metabolites Rev 2 March 2020 34916634fnl
- Estimating-the-Maximum-Safe-Starting-Dose-in-Initial-Clinical-Trials-for-Therapeutics-in-Adult-Healthy-Volunteers