TY  - CHAP
M1  - Book, Section
TI  - Drug Product Performance, In Vivo: Bioavailability and Bioequivalence
A1  - Davit, Barbara
A1  - Conner, Dale
A1  - Shargel, Leon
A2  - Shargel, Leon
A2  - Yu, Andrew B.C.
PY  - 2016
T2  - Applied Biopharmaceutics & Pharmacokinetics, 7e
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.  
SN  - 
PB  - McGraw-Hill Education
CY  - New York, NY
Y2  - 2024/04/19
UR  - accesspharmacy.mhmedical.com/content.aspx?aid=1117900584
ER  -