Preclinical Investigation for Herbal Medicine


Noor Rain A. and Zakiah I.
Herbal Medicine Research Center. Institute for Medical  Research, Jalan Pahang, 50588.
Kuala Lumpur




Preclinical Investigation for Herbal Medicine


Medicinal and Aromatic Plants Seminar (MAPS 2010)


3rd August - 4th August 2010

Place Held

Forest Research Institute Malaysia(FRIM)


Typically, the processes for the development of an herbal product (with claims) are long and demanding as well as may take up many years. These processes involve stages such as discovery, product selection (screening), preclinical testing (study in animals to determine the safety profile of the product in animal) and clinical trial (trial in human, phases I, II, and III). Preclinical study is a research conducted on a product before clinical trials are carried out, during which important data is collected in a manner required by a quality system such as Good Laboratory Practice or “GLP”. Pre-clinical studies must adhere to GLP to be acceptable for submission to regulatory agencies. The data is in support of safety for the product and allows researchers to allometrically estimate a safe starting dose for the product for clinical trial in humans. The main goal of a preclinical study in product development is to collect data in support of safety. The information collected from these studies is vital to safe human testing. A preclinical safety Study involves both in vitro and in vivo investigations. From in vivo pre-clinical trials, “No Observable Effect Levels” (NOEL) on drugs are established, which will be used to determine the initial Phase 1 clinical trial dosage levels. The use of herbal medicines is widespread, but there are problems with safety. Herbal medicine has been used for a long time in folk medicines. Therefore, they are often considered and believed to be safe. Long usage does not necessarily establish its safety. The safety of herbal products is of particular importance since majority of these products are self prescribed and are claimed to be useful to treat minor and chronic conditions. The more subtle and chronic forms of toxicity from these products may well have been overlooked by previous generations but are of concern nowadays when assessing product safety. Therefore, there is a need for preclinical studies for herbal medicine for scientific evidence for safety and efficacy. In Malaysia, herbal medicines have to comply with the safety requirements of the Health Ministry’s Drug Control Authority. Herbal products not regulated as medicines cannot be seen as alternative therapies unless the safety profile and effectiveness have been scientifically proven. Adopting an agent into practice follows critical evaluation. The emphasis of WHO on the safety and efficacy of herbal medicine includes research on preclinical toxicology study. In order for safety data to be of quality, acceptable by national regulators and meet international regulatory requirement, the preclinical toxicology study required strict adherence to GLR In addition, sound scientific evidence supporting the herbal products improves business prospects in the country as wells as the international markets.


Good Laboratory Practice or GLP; pre-clinical toxicity study; safety of herbal products or medicines


Session 2: Invited lecture 5


Harnessing the Tropical heritage: Recent Advances in R&D and commercialization