RT Book, Section
A1 Murray P., Ducharme
A1 Deniz, Ozdin
A2 Ducharme, Murray P.
A2 Shargel, Leon
SR Print(0)
ID 1188772233
T1 Clinical Development and Therapeutic Equivalence of Generic Drugs and Biosimilar Products
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=1188772233
RD 2024/04/17
AB Explain  the  concepts  of  interchangeability  and  bioequivalence  for  generic  drug  products  in  the  United  States,  Canada,  and  Europe.Explain  why  a  generic  drug  product  evaluated  to  be  therapeutically  equivalent  and  interchangeable  in  one  region  may  not  be  a  therapeutic  equivalent  in  another  region.Describe  what  “branded  generics”  are  and  why  they  are  more  prevalent  in  developing  countries.Define  the  differences  between  products  classified  as  “AA”  versus  “AB”  in  the  FDA  Orange  Book.Explain  the  differences  between  bioequivalence  and  a  single  PK  equivalence  study.List  the  requirements  for  clinical  generic  drug  product  development  for  the  United  States,  European,  and  Canadian  markets.Define  the  term  biosimilar.List  the  main  differences  associated  with  the  clinical  development  of  a  biosimilar  versus  that  of  a  generic  drug  product.Describe  what  are  called  “locally-acting”  drug  products  by  regulators,  and  explain  what  particular  challenges  are  associated  with  their  clinical  development  from  a  bioequivalence  point  of  view.