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Approaching the problem of bioequivalence of herbal medicinal products
Author(s) -
Loew D.,
Kaszkin M.
Publication year - 2002
Publication title -
phytotherapy research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.019
H-Index - 129
eISSN - 1099-1573
pISSN - 0951-418X
DOI - 10.1002/ptr.1248
Subject(s) - bioequivalence , biopharmaceutical , pharmacology , innovator , drug , medicine , traditional medicine , bioavailability , microbiology and biotechnology , biology , computer science , intellectual property , operating system
Abstract Herbal medicinal products (HMP) contain exclusively herbal drugs or herbal drug preparations (HDP) and are a complex mixture of different compounds, which may act in an agonistic, synergistic, complementary, antagonistic or toxic way. A specific scientific challenge is for methods to prone the bioequivalence of herbal drug preparations (HDP). Depending on the type of herbal drug preparations, different approaches are possible. If the constituents responsible for therapeutic activity are known, the concept of essential similarity used with chemically defined substances can be fully applied. For extracts with unknown active markers, data on defined chemical constituents are useful for control purposes (charge conformity), but not sufficient to prove bioequivalence. In this case bioassays or pharmacological studies, which measure therapeutically relevant activity, should be used. A phytogeneric is only comparable to the innovator preparation under the following conditions: (i) pharmaceutical equivalence (standardization), (ii) biopharmaceutical equivalence ( in vitro dissolution), (iii) bioequivalence with different endpoints ( in vitro model, animal model) or (iv) clinical study. An uncritical substitution of herbal drug preparations without considering these scientific criteria should be avoided. Copyright © 2002 John Wiley & Sons, Ltd.