每位评审官会选出一位获胜者,并且他们可能会恋爱结婚!
除非评审官另有说明,任一批次的样品,最好是较早批次,都可以用于新药申请及其补充申请。
Unless specified differently by the reviewer, samples from any batch, preferably samples from an aged batch, may be selected for NDAs and NDA supplemental applications.
仿制药申请的的评审官着重于生物等效性资料,化学和生物资料,工厂检查的要求和药品标签信息等。
Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.
仿制药申请的的评审官着重于生物等效性资料,化学和生物资料,工厂检查的要求和药品标签信息等。
Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.
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