Generics, chemisimilars and biosimilars: Is clinical testing fit for purpose?

British Journal of Clinical Pharmacology

Volumn 75, Issue 1, 2013, Pages 7-14

  Warren, John B ^a  

^a Medicines Assessment Ltd   (United Kingdom)

Author keywords

Biomarkers; EMA; FDA; Hatch Waxman; Inhalers; Pharmacokinetics

Indexed keywords

GENERIC DRUG; PLACEBO;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CONTROLLED RELEASE FORMULATION; CORRELATION ANALYSIS; COST CONTROL; DEAMINATION; DRUG BINDING SITE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG OXIDATION; DRUG QUALITY; DRUG SAFETY; DRUG SYNTHESIS; GLYCOSYLATION; HUMAN; INTERNATIONAL NORMALIZED RATIO; LABORATORY TEST; LONG TERM CARE; NITROSYLATION; PHOSPHORYLATION; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PROBABILITY; QUALITY CONTROL; RELIABILITY; REVIEW; RISK BENEFIT ANALYSIS; SINGLE DRUG DOSE;

BIOSIMILAR PHARMACEUTICALS; DRUG INDUSTRY; DRUGS, GENERIC; HUMANS; NEBULIZERS AND VAPORIZERS; THERAPEUTIC EQUIVALENCY;

EID: 84871157556     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04323.x     Document Type: Review

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