Some studies on this subject were presented during the conference, (21) including anti-colon-cancer effects of Thymoquinone, a natural drug with pro-oxidant activities. Also, promising data was shown about Salograviolide A isolated from the indigenous Lebanese plant Centaurea ainetensis. Salograviolide A causes growth inhibition and cell death in skin cancer cells. In vivo and Clinical Trials The use of in vivo experimentation and clinical trials are important methods, and despite the limitations of animal experimentation, they are still crucial in herbal drug development. Developing a therapeutic remedy from herbal origins is a complex process that has to pass through various important preclinical steps. These steps include standardization of the herbal extract, providing evidence of pharmacological activity, and providing evidence of safety. Pharmacological screening has to be carried out ulti- mately on laboratory animals and this has many ethical considerations regarding the proper conduct of such screening and the expected value of its outcomes. The use of laboratory animals is unavoidable but should be rationalized through careful planning. Preliminary in vitro testing should give some idea of the possible mechanisms of action and potential therapeutic usefulness of an herbal extract, but obviously has its shortcomings. Such tests provide no information regarding biotransformation of the extract in the body, pharmacokinetic aspects of absorption and fate. To determine potential therapeutic usefulness in a certain disease state, however, appropri- ate animal models have been developed that mimic the human condition to some extent. Animal models have been developed for many conditions, including hyperten- sion, myocardial infarction, atherosclerosis, ischemia, bronchial asthma, arthritis, diabetes, Parkinsonism, depression, epilepsy, gastric ulcers, reflux oesophagitis, inflammatory bowel disease, cancer, etc. Extrapolation of results from animal to human should be carried out with great caution. Animal models only mimic the symptoms in humans, but not the etiology or the overall clinical picture. Thus, it is not possible to say that an extract, which lowers blood pressure in rats rendered hypertensive by L-NAME, where the hypertension is due to endothe- lial dysfunction, would function as well in a patient whose hypertension is due to any other cause. Strepto- zotocin induced diabetes in rat is not exactly the same as diabetes in humans: not only is the condition different in etiology, but the human response may be quite different from that of the rat, particularly since diabetes in humans is normally associated with a number of events that may not be seen in the rat. The metabolism and pharmacokinetic behavior of active constituents may differ from species to species, and accordingly the interpretation of animal findings may eCAM 2010;7(4) 423 not necessarily be applicable to humans. In general, therefore, animal models are artificially induced condi- tions said to be analogous to the human diseases they are intended to simulate, but they differ substantially from their human ‘counterparts’ in both cause and clinical course. This also holds true for toxicological studies. Such studies should always be performed according to international guidelines and are a prerequisite for eval- uating the safety of potentially useful therapeutic agents. Market Authorization Regulations for Herbal Products Regulations are needed to ensure safety, quality and effi- cacy of herbal medicines. Countries define herbal medic- ines differently and have adopted various approaches to licensing, dispensing, manufacturing and trading these products. The main differences in the regulations govern- ing herbal medicines in different countries were discussed at the conference. Within Europe, and according to the country using them, herbal medicines are either fully licensed as medicines with efficacy proven by clinical trials, or have a more simplified approach toward proof of efficacy. In the USA, most herbal products are considered dietary supplements and thus are not required to meet the more stringent standards for drugs specified in the Federal Food, Drugs and Cosmetic Act. 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