title: Relationships among product characterization, process validation and preclinical/clinical studies for well-characterized products.
authors.affiliation: SmithKline Beecham Pharmaceuticals, King of Prussia, PA 19406, USA.
authors.forename: A S
authors.initials: AS
authors.lastname: Lubiniecki
mesh_terms: D000818:Animals; D001688:Biological Products / Q000302:isolation & purification* / Q000494:pharmacology / Q000592:standards; D001709:Biotechnology; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D012449:Safety
chemical_list: D001688:Biological Products