RT Book, Section
A1 Dixit, Trupti
A1 Shargel, Leon
A2 Ducharme, Murray P.
A2 Shargel, Leon
SR Print(0)
ID 1188771893
T1 Rational Drug Product Development, Quality, and Performance
T2 Shargel and Yu's Applied Biopharmaceutics and Pharmacokinetics, 8e
YR 2022
FD 2022
PB McGraw-Hill Education
PP New York, NY
SN 9781260142990
LK accesspharmacy.mhmedical.com/content.aspx?aid=1188771893
RD 2024/04/19
AB Describe  the  types  of  safety  and  efficacy  risks  that  may  occur  after  taking  a  drug  product  and  various  means  for  preventing  these  risks.List  the  major  reasons  that  a  drug  product  might  be  recalled  due  to  quality  defects.Understand  how  biopharmaceutics  risk  assessment  road  map  (BioRAM)  can  lead  to  rational  drug  product  development.Differentiate  between  drug  product  quality  and  drug  product  performance.Differentiate  between  quality  control  (QC)  and  quality  assurance  (QA).Explain  how  quality  by  design  (QbD)  ensures  the  development  and  manufacture  of  a  drug  product  that  will  deliver  consistent  quality  and  performance.Define  quality  target  product  profile  (QTPP)  and  explain  how  QTPP  is  different  from  conventional  quality  product  criteria.Describe  the  quality  principles  underlying  basis  for  the  development,  manufacture,  and  QA  of  the  drug  product  throughout  its  life  cycle.Describe  how  product  specifications  relate  to  drug  product  quality  and  the  relevance  to  QA  of  the  drug  product  through  QbD.Define  critical  quality  attributes  and  how  these  attributes  relate  to  clinical  safety  and  efficacy.Explain  how  postapproval  changes  in  a  drug  product  may  affect  drug  quality  and  performance.