1. Expression system 2. Manufacturing process 3. Assessment of physiochemical properties 4. Functional activities 5. Receptor binding and immunochemical properties 6. Measurement of impurities 7. Stability under multiple stress conditions…

  Acute infusion/injection reactions Delayed infusion/injection reactions Timing of onset Within first hours of dose 3–14 days Clinical presentation Mild: Fever, nausea, vomiting, wheal formation, pruritus, erythema Serum sickness-like syndrome:…

  Crohn’s disease Ulcerative colitis SONIC [7] COMMIT [9] UC-SUCCESS [8] IFX IFX + AZA IFX IFX + MTX IFX IFX + AZA Clinical remission (%) 44 57 78 76…

Fig. 13.1 (a) Relative risk by decade, Crohn’s disease. (b) Relative risk by decade, ulcerative colitis Non-melanoma Skin Cancer In the USA, NMSC is the most commonly diagnosed malignancy. NMSC…

Fig. 16.1 Mechanism of action of adhesion molecules in the intestinal endothelium and their blockage by anti-adhesion drugs Integrins involved in T-cell migration are leucocyte function-associated antigen 1 (LFA-1 or…

Time post-resection   1 year Clinical 0–44% Endoscopic 0–84% Surgical 4–25% 5 years Clinical 32% Endoscopic 55–77% Surgical 4–25% 10 years Clinical 52% Endoscopic 74% Surgical 12–57% Adapted from Connelly et…

Assay type Advantages Disadvantages Commercial example in United States ELIS A •  Ease of administration • Generally low cost •  False positives •  Interference in measuring antibodies in the presence of…