KarenB
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As most of us know, the FDA requires the bio-equivalent in generic drugs to be betweeen 80% to 125% (or something along that line) of the name-brand drug.
Which can be a problem if switching from name-brand to generic, or switching from one generic to another. One can end up getting quite a bit less or more of the active ingredient. So, if using generic, it's important for the pharmacy to stick with the same supplier.
So...this is our dilemma -- we're back in the States now, and need to know which pharmacies are best at NOT switching suppliers.
The pharmacies in our town are:
Rite-Aid
Walgreens
Medicine Shoppe
There's also a Walmart, but I remember having bad experiences with them in the past -- can't remember exactly what, but seemed like something to do with insurance authorization or something.
There's also a Wegman's -- not in our town, but a 20 minute drive away.
FDA regs on bioequivalency:
The statistical methodology for analyzing these bioequivalence studies is called the two one-sided test procedure. Two situations are tested with this statistical methodology. The first of the two one-sided tests determines whether a generic product (test), when substituted for a brand-name product (reference) is significantly less bioavailable. The second of the two one-sided tests determines whether a brand-name product when substituted for a generic product is significantly less bioavailable. Based on the opinions of FDA medical experts, a difference of greater than 20% for each of the above tests was determined to be significant, and therefore, undesirable for all drug products. Numerically, this is expressed as a limit of test-product average/reference-product average of 80% for the first statistical test and a limit of reference-product average/test-product average of 80% for the second statistical test. By convention, all data is expressed as a ratio of the average response (AUC and Cmax) for test/reference, so the limit expressed in the second statistical test is 125% (reciprocal of 80%).
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm
Which can be a problem if switching from name-brand to generic, or switching from one generic to another. One can end up getting quite a bit less or more of the active ingredient. So, if using generic, it's important for the pharmacy to stick with the same supplier.
So...this is our dilemma -- we're back in the States now, and need to know which pharmacies are best at NOT switching suppliers.
The pharmacies in our town are:
Rite-Aid
Walgreens
Medicine Shoppe
There's also a Walmart, but I remember having bad experiences with them in the past -- can't remember exactly what, but seemed like something to do with insurance authorization or something.
There's also a Wegman's -- not in our town, but a 20 minute drive away.
FDA regs on bioequivalency:
The statistical methodology for analyzing these bioequivalence studies is called the two one-sided test procedure. Two situations are tested with this statistical methodology. The first of the two one-sided tests determines whether a generic product (test), when substituted for a brand-name product (reference) is significantly less bioavailable. The second of the two one-sided tests determines whether a brand-name product when substituted for a generic product is significantly less bioavailable. Based on the opinions of FDA medical experts, a difference of greater than 20% for each of the above tests was determined to be significant, and therefore, undesirable for all drug products. Numerically, this is expressed as a limit of test-product average/reference-product average of 80% for the first statistical test and a limit of reference-product average/test-product average of 80% for the second statistical test. By convention, all data is expressed as a ratio of the average response (AUC and Cmax) for test/reference, so the limit expressed in the second statistical test is 125% (reciprocal of 80%).
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm
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