Concepedia

Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A.

Kuei‐Meng Wu, Jinhui Dou, Hanan Ghantous, Shaw Chen, Anita Bigger, Debra Birnkrant

Regulatory Toxicology and Pharmacology · 2009 · 27 citations · 4 references

Concepts

PharmacyPharmacologyToxicologyGenetic ToxicologyPharmaceutical ToxicologyRegulatory ToxicologyGenotoxicity AssessmentGenotoxicity MechanismsGenotoxicity Risk AssessmentGenotoxicity TestingMutagenicity AssessmentRegulatory GenotoxicologyBiological Monitoring Of GenotoxicantsDrug Product DevelopmentGenotoxicityRegulatory Genotoxicity AssessmentRegulatory Genotoxicity Testing

References

4

New therapies from old medicines

Shaw T. Chen, Jinhui Dou, Robert Temple et al. · Nature Biotechnology · 2008 · 102 citations · Full text

Medicine, Pharmacology, Pharmacotherapy +3

Complexities of the herbal nomenclature system in traditional Chinese medicine (TCM): Lessons learned from the misuse of Aristolochia-related species and the importance of the pharmaceutical name during botanical drug product development

K.M. Wu, James G. Farrelly, Roy Upton et al. · Phytomedicine · 2006 · 91 citations

Life Sciences, Botany, Plant Sciences +16

Regulatory science: a special update from the United States Food and Drug Administration

K.M. Wu, J G DeGeorge, Aisar Atrakchi et al. · Toxicology Letters · 2000 · 29 citations

Pharmacy, Pharmacology, Regulatory Policy +15

Final report on carcinogens background document for aristolochic acids.

PubMed · 2008 · 16 citations

Medicine, Pharmacology, Toxicology +9