Evaluation of orally administered highly variable drugs and drug formulations.
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Pharmacokinetics of ethionamide administered under fasting conditions or with orange juice, food, or antacidsIndividualized, discrete event, simulations provide insight into inter- and intra-subject variability of extended-release, drug products.PhRMA perspective on population and individual bioequivalence.The effect of dosing regimen on the pharmacokinetics of risedronate.Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.Novel methods to assess bioequivalence.Current regulatory approaches of bioequivalence testing.Innovative approaches for demonstration of bioequivalence: the US FDA perspective.Bioequivalence accomplishments, ongoing initiatives, and remaining challenges.Testing for bioequivalence of highly variable drugs from TR-RT crossover designs with heterogeneous residual variances.Perspectives on variability in pharmacokinetics of an oral contraceptive product.Bioequivalence of generic alendronate sodium tablets (70 mg) to Fosamax® tablets (70 mg) in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study.Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics.Adjusted indirect treatment comparison of the bioavailability of WHO-prequalified first-line generic antituberculosis medicines.Tacrolimus pharmacokinetics and dose monitoring after lung transplantation for cystic fibrosis and other conditions.Inflation of Type I Error in the Evaluation of Scaled Average Bioequivalence, and a Method for its Control.
P2860
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P2860
Evaluation of orally administered highly variable drugs and drug formulations.
description
1996 nî lūn-bûn
@nan
1996年の論文
@ja
1996年学术文章
@wuu
1996年学术文章
@zh-cn
1996年学术文章
@zh-hans
1996年学术文章
@zh-my
1996年学术文章
@zh-sg
1996年學術文章
@yue
1996年學術文章
@zh
1996年學術文章
@zh-hant
name
Evaluation of orally administered highly variable drugs and drug formulations.
@en
type
label
Evaluation of orally administered highly variable drugs and drug formulations.
@en
prefLabel
Evaluation of orally administered highly variable drugs and drug formulations.
@en
P2093
P356
P1476
Evaluation of orally administered highly variable drugs and drug formulations.
@en
P2093
Dobrinska MR
Endrenyi L
Fairweather W
Gillespie W
Gonzalez MA
P304
P356
10.1023/A:1016468018478
P577
1996-11-01T00:00:00Z