Generic SubstitutionIssues for Problematic Drugs
作者:
JAMES HENDERSON,
RICHARD ESHAM,
期刊:
Southern Medical Journal
(OVID Available online 2001)
卷期:
Volume 94,
issue 1
页码: 16-21
ISSN:0038-4348
年代: 2001
出版商: OVID
数据来源: OVID
摘要:
The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (eg, digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for which no New Drug Applications (NDAs) currently exist. However, commercially available generic products for both of these drugs have not been determined by the FDA to be therapeutically equivalent to the innovator products. Generic versions of warfarin have been approved by the FDA as being therapeutically equivalent to the innovator products, as have generic versions of the rescue inhaler albuterol. Yet, misinformation and myths persist regarding the adequacy and proven reliability of the FDA's determination of bioequivalence for these products.
点击下载:
PDF
(37KB)
返 回