Tag: <span>aggregate</span>

Tag: aggregate

31. Safety Signal – Introduction

What is Signal? A signal is essentially a hypothesis of a risk with a medicine with data and arguments that support it, derived from data from one or more of many possible sources.  The evidence in a signal is not conclusive (is, in the technical sense, uncertain), and is only …

29. Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER)

Periodic safety update report (PSUR) provides a periodic and comprehensive assessment of the worldwide safety data of a marketed drug. Over time it was recognized that the risk of the marketed drug should be assessed in the light of its benefits and change in the risk estimate overtime. Consequently, the …

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