Sjöholm I
Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M. 1997(91):107-10.
A general monograph for allergen products has now been adopted by the European Pharmacopoeia Commission. It is based on the use of an In-House Reference Preparation (IHRP), which shall be used in the control of every production batch after appropriate characterization. This characterization will depend on the intended use of the product. When possible, the biological potency should be established by skin testing and expressed in biological units. The monograph is the first mandatory regulation in Europe for allergen products and will guarantee the consistent composition and potency of the products on the market.
欧洲药典委员会现已采用了一份过敏原产品通用专论。它基于内部参考制剂（IHRP）的使用，在对每个生产批次进行适当表征后，应使用该制剂进行控制。这种表征将取决于产品的预期用途。在可能的情况下，生物活性应通过皮肤试验确定，并以生物单位表示。该专论是欧洲对过敏原产品的首个强制性法规，将确保市场上产品成分和活性的一致性。
