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Biosimilar applicants must conduct extensive analytical comparisons, and often clinical pharmacology and clinical studies, to establish biosimilarity

In addition to analysis in blood and urine, acylcarnitine profiling can also be done in cultured fibroblasts after a fatty acid loading test [41]

The three most common causes: (1) peptide degradation due to improper storage (temperature excursions above 8C after reconstitution), (2) complete avoidance of UV exposure (MT2 requires UV to trigger melanosome transfer), or (3) dosing below the melanogenic threshold (fewer than 0.25mg per injection or inconsistent dosing frequency)

Dimensions: 5100 x 3387 px | 43.2 x 28.7 cm | 17 x 11.3 inches | 300dpi Date taken: 8 August 2008 Location: Northern Ireland, UK