Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Test procedures in the specifications for herbal medicinal products according to CPMP / CVMP-guidelines compared with those for chemically defined medicinal products ***

Dr. Kirsten Hiebenthal-Millow (Abschlußjahr: 2003)

A specification constitutes a list of tests, references to analytical procedures and appropriate acceptance criteria developed by the applicant and approved by the regulatory authority. The tests listed in the specification belong to one of the following five categories: definition / description, test of identity, test of purity, assay and other tests. Different CPMP/CVMP-guidelines are published that give guidance on how to establish which tests should be included in the specification of herbal medicinal products and chemically defined medicinal products. In this masterthesis it is summarised and compared which test parameters have to be included into a specification of a herbal drug, herbal preparation and herbal medicinal product on the one side and starting material, drug substance and drug product of chemically defined medicinal products one the other side according to these CPMP/CVMP-guidelines.

The principle difference between herbal medicinal products and chemically defined medicinal products is that the active ingredient of the herbal medicinal product constitutes a mixture of a variety of substances. As a consequence different test parameters have to be included into the specification as to test a material of complex composition calls for other tests than defining, identifying, quantifying etc a single substance.

Altogether the comparison yields that the definition and tests on identity are more significant for herbal drugs, herbal preparation and herbal medicinal products, whereas the test on purity and assay is of more significance for starting material, drug substance and drug product of chemically defined medicinal products.

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