Safety Pharmacology of Herbal Products

  • Gert LaekemanEmail author


This chapter aims at a comprehensive review on safety pharmacology. Foxglove and the discovery of acetylsalicylic acid are given as historical examples emerging from benefit-risk balance. Before going to practical examples of in vitro research, a theoretical approach is given to competitive and non-competitive antagonism. Results of experimental work are presented in order to show how early toxic activity can be detected and can even be related to mechanisms of action (e.g., the indole alkaloids of Pterotaberna inconspicua and the sesquiterpene lactone vernolepin from Vernonia amygdalina). If substances can be detected as responsible agents for a biological activity of complex mixtures, the safety approach can be simplified (e.g., eugenol in powder of Myristica fragrans). Pharmacokinetic considerations are important when taking into consideration safety and therapeutic issues of red yeast rice. A pharmacokinetic schedule is given and illustrated with herbal examples. Finally, a framework of questions is proposed to cover quality as well as pre-clinical and clinical safety.


Pharmacology Safety History Checklist Pharmacokinetics Pharmacodynamics 


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Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  1. 1.Clinical Pharmacology and PharmacotherapyFaculty of Pharmaceutical Sciences, KU LeuvenLeuvenBelgium

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