Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and ...

Maximizing and validating the stability of a drug is critical throughout its life cycle, beginning in the development phase of an active pharmaceutical ingredient (API), continuing through the final ...

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA ...

Oxidation is a major degradation pathway for active pharmaceutical ingredients (APIs), particularly in solid dosage forms. It ...

While stability testing for small molecule drugs is well established, its counterpart for biologicals is still evolving. Dozens of techniques have emerged for characterizing proteins, ranging from the ...

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex. The purpose of stability testing ...

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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 ...