Proton Pump Inhibitors - CME Conferences
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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 Therapeutic Equivalence of Generic Drugs: FDA Requirements • Pharmacologically equivalent – Contains same amount of active drug – Meets USP standard for purity, strength, quality • Bioequivalent (mean AUC values are typically within 3-4% of each other) • Adequate labeling • Manufactured in compliance with GMP 32 Bioequivalence of Drugs: FDA Accepted Parameters • Single dose of reference drug and test drug given to 24 to 36 healthy adults in a crossover design. Bioequivalence accepted when the 90% confidence interval of the ratios – AUC – C max – T max • Fall between 0.8 and 1.25 (log-transformed data) • The generic manufacturer’s main challenge has been to make a generic that was absorbed as poorly as the brand (IE phenytoin delayed – Dilantin) Meyer MC. J Clin Psychiatry 2001;62(suppl 5):4-9 33 Wayne Weart, Pharm D Cost Effective Rx
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 35 Wayne Weart, Pharm D Cost Effective Rx
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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012<br />
Therapeutic Equivalence of<br />
Generic Drugs: FDA Requirements<br />
• Pharmacologically equivalent<br />
– Contains same amount of active drug<br />
– Meets USP standard for purity, strength, quality<br />
• Bioequivalent (mean AUC values are typically<br />
within 3-4% of each other)<br />
• Adequate labeling<br />
• Manufactured in compliance with GMP<br />
32<br />
Bioequivalence of Drugs:<br />
FDA Accepted Parameters<br />
• Single dose of reference drug and test drug given to<br />
24 to 36 healthy adults in a crossover design.<br />
Bioequivalence accepted when the 90% confidence<br />
interval of the ratios<br />
– AUC<br />
– C max<br />
– T max<br />
• Fall between 0.8 and 1.25 (log-transformed data)<br />
• The generic manufacturer’s main challenge has been<br />
to make a generic that was absorbed as poorly as the<br />
brand (IE phenytoin delayed – Dilantin)<br />
Meyer MC. J Clin Psychiatry 2001;62(suppl 5):4-9<br />
33<br />
Wayne Weart, Pharm D<br />
Cost Effective Rx
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