RT Book, Section
A1 Davit, Barbara
A1 Conner, Dale
A1 Shargel, Leon
A2 Shargel, Leon
A2 Yu, Andrew B.C.
SR Print(0)
ID 1117900584
T1 Drug Product Performance, In Vivo: Bioavailability and Bioequivalence
T2 Applied Biopharmaceutics & Pharmacokinetics, 7e
YR 2016
FD 2016
PB McGraw-Hill Education
PP New York, NY
SN 9780071830935
LK accesspharmacy.mhmedical.com/content.aspx?aid=1117900584
RD 2024/04/19
AB Define  bioavailability,  bioequivalence,  and  drug  product  performance.Explain  why  certain  drugs  and  drug  products  have  low  bioavailability.Explain  why  first-pass  effect  as  well  as  chemical  instability  of  a  drug  can  result  in  low  relative  bioavailability.Distinguish  between  bioavailability  and  bioequivalence.Explain  why  relative  bioavailability  may  have  values  greater  than  100%.Explain  why  bioequivalence  may  be  considered  as  a  measure  of  drug  product  performance.Describe  various  methods  for  measuring  bioavailability  and  the  advantages  and  disadvantages  of  each.Describe  the  statistical  criteria  for  bioequivalence  and  90%  confidence  intervals.Explain  the  conditions  under  which  a  generic  drug  product  manufacturer  may  request  a  waiver  (biowaiver)  for  performing  an  in  vivo  bioequivalence  study.Define  therapeutic  equivalence  and  explain  why  bioequivalence  is  only  one  component  of  the  regulatory  requirements  for  therapeutic  equivalence.