Affiliation:
1. Convalife Pharmaceuticals Shanghai China
Abstract
AbstractNeratinib (an active pharmaceutical ingredient [API]) is an irreversible pan‐human epidermal growth factor receptor (HER) inhibitor used to treat HER2‐positive breast cancer. The dosage form (marketed in the United States, China, Europe, and other regions) is a tablet for oral administration, and the brand product (NERLYNX) has patent protection for the crystalline neratinib maleate monohydrate form. This paper describes the product development using stable crystalline neratinib maleate anhydrous form, stability study, bioequivalence (BE) study of the products, and discussion of the adverse effects observed in the clinical study.
Funder
Science and Technology Innovation Plan Of Shanghai Science and Technology Commission
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