Geigert, J. 1948-

The challenge of CMC regulatory compliance for biopharmaceuticals / John Geigert - New York : Kluwer Academic/Plenum Publishers, 2004 - xxiii, 350 p. : ill. ; 25 cm.

References : p. 331-346

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Biopharmaceutics--standards--United States
Guideline Adherence--legislation & jurisprudence--United States
Quality control--United States

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