Mptm steroids

Example 6: Gastrointestinal adverse events observed in multiple dose neratinib maleate clinical studies of cancer patients Six different multiple dose clinical studies using neratinib maleate (single agent and combination) in cancer patients (> 400 patients) also indicated that gastrointestinal adverse events predominated as the adverse events observed in clinical studies of cancer patients. Adverse events in clinical studies of cancer patients were observed and classified as follows:

- Nausea, Vomiting, Diarrhea, Dehydration, Anorexia (-95%) - Asthenia, Fatigue (-30-60%) - Rash (-20-25%) - Elevated ALT, AST (< 10%) Example 7: Effect of Concurrent Administration of Ketoconazole on GI
Tolerability Exposure studies were performed to determine if gastrointestinal tolerability is related to systemic exposure of neratinib maleate. The results indicated that GI
tolerability (diarrhea) is not related to systemic exposure.

...............................................................................
.........................................................................
Me. 0. 0 acanaw ...............................................................................
.........................................................................
...............................................................................
..........................................................................
...............................................................................
........................................................................
...............................................................................
..........................................................................
Cmax (ng/ml) [] 201 [164]
UC t 835 [727] 355 [3527]
hr*n /ml UC- 903 [802] 660 [3796]
hr*n /ml Subjects Reporting GI AEs GI Disorders Example 8: Extended Release Neratinib Maleate Formulation Ingredients Modified release Spheroids in Capsule % W/W Composition Uncoated Spheroids Neratinib maleate equivalent to free base) Microcrystalline Cellulose (Avicel PH 101) Polysorbate-80 Total 100 Sub-Coating Hypromellose, 3 cps % weight gain Modified Release Coating Surelease 10% weight gain (ethylcellulose aqueous dispersion)

Mptm steroids

mptm steroids

Media: