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[CITATION] Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations

US Food - 2011
Cited by 7 - Related articles

[PDF] A therapeutic equivalence program: evidence-based promotion of more efficient use of medicines

[PDF] from mja.com.auI Larmour, S Pignataro, KL Barned… - The Medical journal of …, 2011 - mja.com.au
METHODS The TEP was introduced at SH in the 2006– 07 financial year, and we report findings
to the 2009–10 financial year. It was approved by the Southern Health Therapeutics Com- mittee
and the Southern Health Medical Executive Committee. Representatives from these ...
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The Need for Additional Metrics to Assess Therapeutic Equivalence of Some Multiphasic Modified-Release Products

PM Kondra, L Endrenyi… - Clinical Therapeutics, 2011 - Elsevier
Advisory committees for the regulatory agencies of the United States (US Food and Drug Administration
[FDA]) and Canada (Health Canada) recently considered issues associated with the determination
of bioequivalence for some multiphasic modified-release (MR) drug products. The FDA ...

Therapeutic equivalence of the generic and the re-ference atorvastatin in patients with increased coronary risk.

M Boh, G Opolski, P Poredosˇ, R Eska… - … angiology: a journal of …, 2011 - ncbi.nlm.nih.gov
AIM.Generic drugs are more and more frequently used instead of originators. However, uncertainty
exists with respect to therapeutic equivalence of generic product with originator one.
Therefore, in this study efficacy and safety of generic atorvastatin was compared to ...

Bin/Medicine: Statistical Considerations in the Design of Biosimilar Cancer Clinical Trials

C Ahn - 응용통계연구, 2011 - papersearch.net
... protection. When the patent of an innovative (brand- name) small-molecule drug
expires, generic copies of the innovative drug may be marketed if their therapeutic
equivalence to the innovative drug has been shown. However ...

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