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1077 Shaw T. Chen is associate director & botanical team leader, Jinhui Dou is pharmacognosy reviewer, Robert Temple is director of the Office of Drug Evaluation, Rajiv Agarwal is chemistry reviewer, Kuei-Meng Wu is pharmacology reviewer and Susan Walker is director of the Division of Dermatological and Dental Products, Center for Drug Evaluation and(More)
The overall control of the quality of botanical drugs starts from the botanical raw material, continues through preparation of the botanical drug substance and culminates with the botanical drug product. Chromatographic and spectroscopic fingerprinting has been widely used as a tool for the quality control of herbal/botanical medicines. However, discussions(More)
ETHNOPHARMACOLOGICAL RELEVANCE GP-TCM is the first EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. One of the key deliverables of the Work Package 7 in GP-TCM was to investigate information of the existing requirements for registration of TCM products listed by global regulatory bodies. The paper aims to(More)
Toxicological studies constitute an essential part of the effort in developing a botanical supplement into a drug product. The US Food and Drug Administration recently published a draft guidance and established a special botanical review team to assist academic and industry sponsors to manage this and other regulatory considerations related to this unique(More)
Genotoxicity testing is an important part of preclinical safety assessment of new drugs and is required prior to Phase I/II clinical trials. It is designed to detect genetic damage such as gene mutations and chromosomal aberration, which may be reflected in tumorigenic or heritable mutation potential of the drug. Botanical new drugs in the U.S. are entitled(More)
PREFACE As cancer patients continue to explore alternative treatments and practices, the need for reliable scientific data increases. Consumers believe that if a practice or product has been in use for hundreds of years, it must be effective. Many also believe that if a product is " natural, " it must be safe. Unfortunately, many of these assumptions are(More)
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