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Manufacturing issues, microspheres

The manufacturer s User s Manual (Sirtex User s Manual issued March 2002, pp 38-42) suggests three methods of estimating the activity to use for resin microsphere treatment (6.4.3.1) BSA method. [Pg.54]

In developing a microsphere formulation for proteins, it is important to consider the regulatory requirements for the approval of an Investigational New Drug (IND) application by the US. FDA. These requirements include toxicology testing, manufacturing reviews, quality assurance and quality control issues, and preclinical studies. [Pg.35]

See other pages where Manufacturing issues, microspheres is mentioned: [Pg.4]    [Pg.211]    [Pg.400]    [Pg.424]    [Pg.194]    [Pg.108]    [Pg.36]    [Pg.412]    [Pg.146]   
See also in sourсe #XX -- [ Pg.36 ]



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