Some medications are unsuitable for one-dose packaging due to issues such as moisture absorption. A survey of community pharmacists was conducted to understand the status of one-dose packaging and ...
Before their approval, pharmaceuticals not only have to be tested for their effectiveness and safety, but also for their stability, since they are usually stored in pharmacies and private households ...
Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and designing FDA-compliant stability programs ...
Biologics stability testing in pharmaceutical R&D typically requires weeks of waiting between processes. Formulation scientists must develop, assess, and then wait to discover if a formulation remains ...
Table 1. Factors to consider in real-time stability study (click to enlarge). Figure 1. Effect of material change on stability profile (click to enlarge). Figure 2. Correleation of stability failure ...
The safety and quality control of parenteral pharmaceuticals, biologics, and medical devices depend heavily on the Bacterial Endotoxin Test (BET). Historically, Limulus Amebocyte Lysate (LAL), derived ...
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