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During the meeting, a joint session was held with the Expert Committee on Biological Standardization (ECBS) at which a number of matters of common interest, set out below, were discussed.
The Expert Committee on Specifications for Pharmaceutical Preparations recommends holding a joint session with the Expert Committee on Biological Standardization again in 2009, when items of joint interest to the two Committees would be chosen for discussion.
3.1 Transition from biological to chemical assay
A paper on the transition from biological to chemical assay for the quality assurance of medicines had been discussed by both Expert Committees in October 2007. Both Committees had agreed that there was a need to develop guidance in this area and had recognized that the implications of such a transition might be complicated by the consideration of labelling and dose regimens (see also section 4.4.2 of this report).
The transition from use of a biological assay to use of a chemical assay method was an evolutionary …