التفاصيل البيبلوغرافية
| العنوان: |
A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long-Term Safety. |
| المؤلفون: |
Dubcenco, E, Beers‐Block, PM, Kim, LP, Schotland, P, Levine, JG, McCloskey, CA, Bashaw, ED |
| المصدر: |
CTS: Clinical & Translational Science; Sep2017, Vol. 10 Issue 5, p387-394, 8p |
| مصطلحات موضوعية: |
PROTON pump inhibitors, THERAPEUTIC equivalency in drugs, MEDICATION safety, DRUG formularies |
| الشركة/الكيان: |
UNITED States. Food & Drug Administration |
| مستخلص: |
Proton pump inhibitors (PPIs) have become known for both their therapeutic effect and good safety profile. An application was submitted to the US Food and Drug Administration for approval of a reformulated PPI product that failed bioequivalence testing, but was submitted on the basis of the long history of PPI use as a 'surrogate' for equivalence. This review evaluates the safety data for PPIs, discuss variability of pharmacokinetic parameters of PPIs in the reformulation setting, and potential implications of those changes for long-term safety. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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