In-Use Stability Studies for Multi-Dose Products (Part 2: Other WW Authorities)

Introduction Part 1 of this blog (Ref. 1) has described at a high level the guidance provided by the European Medicines Agency (EMA) on in-use stability testing of multi-dose products for human use (Ref. 2 and 3). The second of this 2-part blog series includes for completeness and reference, information on other world-wide (WW) [...]

2022-10-13T07:54:58-04:00August 23rd, 2021|Regulations|

In-Use Stability Studies for Multi-Dose Products (Part 1: EMA)

Introduction and background The ICH stability guideline Q1A(R2) recommends to assess the stability of a drug product to be constituted or diluted before administration (e.g., a powder for injection) as well as after its reconstitution or dilution, and throughout its entire period of use (Ref. 1). This “in-use” stability study has the objective to [...]

2022-10-13T07:55:13-04:00August 10th, 2021|Regulations|
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