Detalhe da pesquisa
1.
Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.
Mol Pharm
; 14(12): 4334-4338, 2017 12 04.
Artigo
Inglês
| MEDLINE | ID: mdl-29076742
2.
Exposure-response analyses of blood pressure and heart rate changes for methylphenidate in healthy adults.
J Pharmacokinet Pharmacodyn
; 44(3): 245-262, 2017 06.
Artigo
Inglês
| MEDLINE | ID: mdl-28214989
3.
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride.
J Pharm Sci
; 110(4): 1513-1526, 2021 04.
Artigo
Inglês
| MEDLINE | ID: mdl-33450218
4.
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate.
J Pharm Sci
; 109(6): 1846-1862, 2020 06.
Artigo
Inglês
| MEDLINE | ID: mdl-32240696
5.
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.
J Pharm Sci
; 107(7): 1761-1772, 2018 07.
Artigo
Inglês
| MEDLINE | ID: mdl-29571740
6.
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
J Pharm Sci
; 106(12): 3421-3430, 2017 12.
Artigo
Inglês
| MEDLINE | ID: mdl-28842299
7.
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin.
J Pharm Sci
; 105(4): 1362-9, 2016 Apr.
Artigo
Inglês
| MEDLINE | ID: mdl-26952879
8.
An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: review of recent cases in psychiatry drugs.
J Clin Pharmacol
; 53(10): 1005-9, 2013 Oct.
Artigo
Inglês
| MEDLINE | ID: mdl-23842865
9.
Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA.
AAPS J
; 14(4): 664-6, 2012 Dec.
Artigo
Inglês
| MEDLINE | ID: mdl-22718306
10.
Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.
AAPS J
; 7(3): E503-12, 2005 Oct 07.
Artigo
Inglês
| MEDLINE | ID: mdl-16353928
11.
The effect of food on the relative bioavailability of rapidly dissolving immediate-release solid oral products containing highly soluble drugs.
Mol Pharm
; 1(5): 357-62, 2004.
Artigo
Inglês
| MEDLINE | ID: mdl-16026005
12.
Biopharmaceutics classification system: the scientific basis for biowaiver extensions.
Pharm Res
; 19(7): 921-5, 2002 Jul.
Artigo
Inglês
| MEDLINE | ID: mdl-12180542