PMID- 24747237
OWN - NLM
STAT- MEDLINE
DCOM- 20140604
LR  - 20140421
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Linking)
VI  - 95
IP  - 5
DP  - 2014 May
TI  - Modeling and simulation of biopharmaceutical performance.
PG  - 480-2
LID - 10.1038/clpt.2014.40 [doi]
AB  - Biopharmaceutical performance refers to the influence of pharmaceutical 
      formulation variables on in vivo performance. New drug product success depends on 
      formulation design for sufficient bioavailability for clinically desired dosing. 
      Regulatory interest in biopharmaceutical performance includes batch-to-batch 
      consistency, acceptability of postapproval changes, and evaluation of 
      bioequivalence (BE) for generic drug products. This Commentary summarizes 
      biopharmaceutical modeling and simulation in the US Food and Drug Administration 
      (FDA) Office of Generic Drugs (OGD) for orally administered generic drugs.
FAU - Zhang, X
AU  - Zhang X
AD  - Office of Generic Drugs, US Food and Drug Administration, Rockville, Maryland, 
      USA.
FAU - Lionberger, R A
AU  - Lionberger RA
AD  - Office of Generic Drugs, US Food and Drug Administration, Rockville, Maryland, 
      USA.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
RN  - 0 (Drugs, Generic)
RN  - 0 (Pharmaceutical Preparations)
SB  - IM
MH  - Administration, Oral
MH  - Biological Availability
MH  - Computer Simulation
MH  - Drug Approval
MH  - *Drug Design
MH  - Drugs, Generic/*administration & dosage/pharmacokinetics
MH  - Humans
MH  - *Models, Biological
MH  - Pharmaceutical Preparations/*administration & dosage
MH  - Therapeutic Equivalency
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2014/04/22 06:00
MHDA- 2014/06/05 06:00
CRDT- 2014/04/22 06:00
PHST- 2014/04/22 06:00 [entrez]
PHST- 2014/04/22 06:00 [pubmed]
PHST- 2014/06/05 06:00 [medline]
AID - clpt201440 [pii]
AID - 10.1038/clpt.2014.40 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2014 May;95(5):480-2. doi: 10.1038/clpt.2014.40.