Evaluation of a scaling approach for the bioequivalence of highly variable drugs. - Wikidata - awgldk - TriplyDB

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

http://www.wikidata.org/entity/Q37386885

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Evaluation of the highly variable agomelatine pharmacokinetics in Chinese healthy subjects to support bioequivalence study An investigation into the influence of experimental conditions on in vitro drug release from immediate-release tablets of levothyroxine sodium and its relation to oral bioavailability.Likelihood approach for evaluating bioequivalence of highly variable drugs.Challenges and opportunities in achieving bioequivalence for fixed-dose combination products.Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.Using partial area for evaluation of bioavailability and bioequivalence.Requirements for generic antiepileptic medicines: a clinical perspective.Current regulatory approaches of bioequivalence testing.Innovative approaches for demonstration of bioequivalence: the US FDA perspective.Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products.Testing for bioequivalence of highly variable drugs from TR-RT crossover designs with heterogeneous residual variances.Bioavailability and Bioequivalence in Drug Development.A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations.Establishment of in vitro-in vivo equivalence of highly variable drugs - a generic product development perspective.Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics.Comparability of critical quality attributes for establishing biosimilarity.Algorithms for evaluating reference scaled average bioequivalence: power, bias, and consumer risk.Viewpoint: observations on scaled average bioequivalence.Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of fimasartan, amlodipine, and rosuvastatin using partial replicated design in healthy adult subjects.

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Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

http://www.wikidata.org/entity/Q37386885

description

article científic

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article scientifique

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articolo scientifico

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artigo científico

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bilimsel makale

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scientific article published on 26 August 2008

@en

vedecký článok

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vetenskaplig artikel

@sv

videnskabelig artikel

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vědecký článek

@cs

name

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

@en

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

@nl

type

label

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

@en

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

@nl

prefLabel

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

@en

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

@nl

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S12248-008-9053-4

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The AAPS Journal

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Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

@en

P2093

Barbara Davit

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Dale Conner

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Donald J Schuirmann

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Fairouz Makhlouf

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Lawrence X Yu

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Sam H Haidar

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Terry Hyslop

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P2860

A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

The bioequivalence of highly variable drugs and drug products.

Bioequivalence approaches for highly variable drugs and drug products.

Bioequivalence revisited.

Limits of 80%-125% for AUC and 70%-143% for Cmax. What is the impact on bioequivalence studies?

Novel scaled average bioequivalence limits based on GMR and variability considerations.

On population and individual bioequivalence.

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450-454

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scholarly article

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10.1208/S12248-008-9053-4

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1010968541

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2761698

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