RT Book, Section
A1 Shargel, Leon
A1 Wu-Pong, Susanna
A1 Yu, Andrew B.C.
SR Print(0)
ID 56605259
T1 Chapter 15. Drug Product Performance, In Vivo: Bioavailability and Bioequivalence
T2 Applied Biopharmaceutics & Pharmacokinetics, 6e
YR 2012
FD 2012
PB The McGraw-Hill Companies
PP New York, NY
SN 978-0-07-160393-5
LK accesspharmacy.mhmedical.com/content.aspx?aid=56605259
RD 2024/04/20
AB Drug  product  performance,1in  vivo,  may  be  defined  as  the  release  of  the  drug  substance  from  the  drug  product  leading  to  bioavailability  of  the  drug  substance.  The  assessment  of  drug  product  performance  is  important  since  bioavailability  is  related  to  the  pharmacodynamic  response  and  related  adverse  events.  Thus,  performance  tests  relate  the  quality  of  a  drug  product  to  clinical  safety  and  efficacy.  Bioavailability  studies  are  drug  product  performance  studies  used  to  define  the  effect  of  changes  in  the  physicochemical  properties  of  the  drug  substance,  the  formulation  of  the  drug,  and  the  manufacture  process  of  the  drug  product  (dosage  form).  Bioavailability  is  one  aspect  of  drug  product  quality  that  links  the  in  vivo  performance  of  a  new  drug  product  to  the  original  formulation  that  was  used  in  clinical  safety  and  efficacy  studies.  Bioequivalence  studies  are  drug  product  performance  tests  that  compare  the  bioavailability  of  the  same  active  pharmaceutical  ingredient  from  one  drug  product  (test)  to  a  second  drug  product  (reference).  Bioavailability  and  bioequivalence  can  be  considered  as  measures  of  the  drug  product  performance  in  vivo.