(1) The proportion of active drug substance to excipient, measured in units of volume or concentration. (2) The strength of a drug product, which indicates the amount of active ingredient in each dosage.
per day; our higher--dosage product is designed to simplify drug therapy and enhance patient compliance by eliminating the larger number of doses patients would be required to ingest because the highest dosage strength currently available is 500 mg.," explains Bruce Downey, chairman and chief executive officer.
Pharmaceuticals company Amneal Biosciences disclosed on Tuesday the approval and availability of its Triamcinolone Acetonide Injectable Suspension, USP in 40 mg/ml dosage strength directly and through wholesalers and distributors.
The quantity limitations are based on the particular drug being prescribed and the dosage strength. The limitations are aligned with Centers for Disease Control recommendations for acute and chronic pain.
The product, which is a programmed death-1 (PD-1) inhibitor, was earlier approved as a two-week dosing schedule for dosage strength of 240mg for the treatment of various cancers including melanoma, non-small cell lung cancer, and renal cell carcinoma.
Critical success factors for prototype formulation development vary by dosage strength. For a high dose (> 250 mg), critical API characteristics include flowability, compressability, and availability of material.