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Sources include: the FDA Orange Book (for small molecules), the FDA Purple Book (for biologics, with awareness of its incompleteness), company 10-K and 10-Q filings (which disclose P.IV notices received and patent litigation), court dockets for pending Hatch-Waxman and BPCIA litigation, and third-party patent intelligence platforms that aggregate and analyze these data sources
Diluting to lower concentrations (5mg in 5mL = 1mg/mL) makes volume measurement easier but increases injection volume, which may matter for subcutaneous administration comfort in smaller research models
doi: 10.1007/s11095-022-03302-1 50
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