Document Detail

Bioequivalence and narrow therapeutic index drugs.
MedLine Citation:
PMID:  7479195     Owner:  NLM     Status:  MEDLINE    
Every prescription written for a generic drug requires an act of faith by the prescriber that any one of the several available products will be therapeutically equivalent to the innovator (brand name) products. Concerns about this act of faith have been expressed for many years, particularly in the wake of the generic scandals that occurred in 1989-1990, and especially relative to the drugs with a narrow therapeutic range. We contend that these drugs are actually the least likely to pose problems in ensuring therapeutic equivalence, but that new criteria must be established for bioequivalence because the present system is wasteful and is stifling innovation in the industry. We propose four suggestions to the scientific and regulatory communities that we believe could assist in modifying the process such that innovation is encouraged and practitioners are reassured relative to the appropriateness of using generic drugs.
L Z Benet; J E Goyan
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Pharmacotherapy     Volume:  15     ISSN:  0277-0008     ISO Abbreviation:  Pharmacotherapy     Publication Date:    1995 Jul-Aug
Date Detail:
Created Date:  1995-12-18     Completed Date:  1995-12-18     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8111305     Medline TA:  Pharmacotherapy     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  433-40     Citation Subset:  IM    
Department of Pharmacy, University of California, San Francisco 94143-0446, USA.
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MeSH Terms
Drug Industry
Drugs, Generic / adverse effects,  pharmacokinetics,  therapeutic use*
Ethics, Pharmacy
Organizational Innovation
Therapeutic Equivalency*
Reg. No./Substance:
0/Drugs, Generic

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