RT Book, Section
A1 Sun, Changquan Calvin
A1 Shargel, Leon
A1 Yu, Andrew BC
A2 Shargel, Leon
A2 Yu, Andrew B.C.
SR Print(0)
ID 1117900680
T1 Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence
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=1117900680
RD 2024/04/18
AB Define  active  pharmaceutical  ingredient1  (API)  and  drug  product  (finished  dosage  form).Define  pharmaceutical  equivalence  (PE)  and  therapeutic  equivalence  (TE).Describe  the  physical  and  biopharmaceutical  properties  of  API  important  in  the  design  and  performance  of  drug  products.Discuss  why  physical  and  biopharmaceutical  properties  of  the  API  and  the  drug  product  are  interrelated  and  important  in  drug  product  design  and  performance.Describe  the  main  methods  used  to  test  (PE)  of  the  active  ingredient  (API)  or  the  dosage  form  (drug  product).Explain  the  relationship  of  PE,  bioequivalence  (BE),  and  therapeutic  equivalence  (TE).Explain  whether  a  generic  drug  product  that  is  not  an  exact  PE  can  be  TE.Explain  why  a  generic  drug  product  with  identical  PE  may  not  lead  to  equivalent  pharmacokinetic  and  pharmacodynamic  performance.