One product, one process, one set of specifications: A proven quality paradigm for the safety and efficacy of biologic drugs

BioPharm

Volumn 14, Issue 3, 2001, Pages 14-24

  Copmann, T ^a   Davis, G ^a   Garnick, R ^a   Landis, J ^a   Lubiniecki, A ^a   Massa, T ^a   Murano, G ^a   Seamon, K ^a   Zezza, D ^a  

^a SmithKline Beecham Pharmaceuticals   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ALGLUCERASE; BIOLOGICAL PRODUCT; GENERIC DRUG; IMIGLUCERASE;

ARTICLE; BIOEQUIVALENCE; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION;

EID: 0035102609     PISSN: 10408304     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. Generic Biologics: Notes from the Path Less Traveled
2. Finding the essentially similar in biotech
3. Hypotension associated with Prekallikrein activator (Hageman Factor Fragments) in plasma protein fraction
4. Contact-activated factors: Contaminants of immunoglobulin preparations with coagulant and vasoactive properties
5. Hepatitis C virus infection associated with administration of intravenous immune globulin: A Cohort Study
6. The cutter incident: Poliomyelitis following formaldehyde-inactivated poliovirus vaccination in the United States during the spring of 1955