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5 days/week (~12 mg/day): ~13 vials 3/week (2 mg): ~12 vials 16 weeks: ~3 vials Insulin Syringes (U-100, 1 mL) Per injection: 1 syringe 8 weeks (5 days/week): ~40 syringes 16 weeks (5 days/week): ~80 syringes Bacteriostatic Water (10 mL bottles) Use ~3.0 mL per 50 mg vial for reconstitution

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however, it is recommended that individuals with sensitive skin or scalp should perform a patch test prior to regular application

ICH Q14 emphasizes analytical procedure development and lifecycle knowledge management for quality-related assessments [14]