کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8773320 1599155 2010 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Bioequivalence testing of immunosuppressants: concepts and misconceptions
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی بیماری‌های کلیوی
پیش نمایش صفحه اول مقاله
Bioequivalence testing of immunosuppressants: concepts and misconceptions
چکیده انگلیسی
Immunosuppressants are considered critical dose/narrow therapeutic index drugs and there is the lingering suspicion among physicians and patients that generic versions may differ in quality and therapeutic efficacy from the brand name drug. The innovator's and the generic active drug molecule are exactly the same and are produced following exactly the same tight rules of good manufacturing practice. Upon oral administration, the drug molecule separates from the formulation and passes the membranes of gut mucosa cells; from this point on, the formulation has no influence on the kinetics of a drug and its biological effects. As formulations may differ, bioequivalence testing in healthy volunteer studies establishes equal relative oral bioavailability. Due to the number of patients required to achieve sufficient statistical power, to test the therapeutic equivalence of two formulations of the same drug with the same bioavailability is an unrealistic goal. An often overlooked fact is that the approval by drug regulatory agencies of several post-approval versions of the innovators' immunosuppressants is based on the identical guidelines used for approval of generics. The FDA has issued specific guidelines describing the requirements for approval of generic versions of tacrolimus, sirolimus, and mycophenolic acid. The standard average bioequivalence approach is recommended and in the cases of tacrolimus and sirolimus, the effect of food should also be tested. No studies in the patient population are requested. Immunosuppressants are not regarded as drugs that require a special status to establish bioequivalence between generic and the innovator's versions.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Kidney International - Volume 77, Supplement 115, March 2010, Pages S1-S7
نویسندگان
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