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Academic Journal

Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability.

  • Authors : Burmeister Getz E; Clinical Pharmacology, Sandoz Inc., 5959 Horton Street, Emeryville, California, 94608, USA. .; Carroll KJ

Subjects: Models, Statistical* ; Pharmaceutical Preparations* ; Therapeutic Equivalency*

  • Source: AAPS PharmSciTech [AAPS PharmSciTech] 2021 Aug 19; Vol. 22 (7), pp. 225. Date of Electronic Publication: 2021 Aug 19.Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932

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Academic Journal

10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented?

  • Authors : Kaza M; Pharmacokinetics Department, Łukasiewicz Research Network - Pharmaceutical Research Institute, 8 Rydygiera Str., 01-793, Warsaw, Poland. .; Sokolovskyi A

Subjects: Research Design* ; Therapeutic Equivalency*; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*administration & dosage

  • Source: Pharmaceutical research [Pharm Res] 2020 Jul 13; Vol. 37 (7), pp. 140. Date of Electronic Publication: 2020 Jul 13.Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Electronic Cited Medium: Internet

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Academic Journal

Biowaiver for Immediate and Modified Release Dosage forms Scientific summary of the CSPS workshop.

Subjects: Therapeutic Equivalency*; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*administration & dosage; Biological Availability

  • Source: Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques [J Pharm Pharm Sci] Publisher: Frontiers Media S. A Country of Publication: Switzerland NLM ID: 9807281 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Performance of the Population Bioequivalence (PBE) Statistical Test with Impactor Sized Mass Data.

  • Authors : Chen S; Department of Statistics, North Carolina State University, Raleigh, North Carolina, USA.; Morgan B

Subjects: Therapeutic Equivalency*; Metered Dose Inhalers/Metered Dose Inhalers/Metered Dose Inhalers/*statistics & numerical data ; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*administration & dosage

  • Source: AAPS PharmSciTech [AAPS PharmSciTech] 2019 Aug 23; Vol. 20 (7), pp. 296. Date of Electronic Publication: 2019 Aug 23.Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932

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Academic Journal

Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products.

  • Authors : Silva MC; Boehringer Ingelheim do Brasil, Sao Paulo, Brazil.; Costa HS

Subjects: Therapeutic Equivalency*; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*administration & dosage ; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*standards

  • Source: AAPS PharmSciTech [AAPS PharmSciTech] 2019 Jun 24; Vol. 20 (6), pp. 235. Date of Electronic Publication: 2019 Jun 24.Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932

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Academic Journal

Pharmaceutical "New Prior Knowledge": Twenty-First Century Assurance of Therapeutic Equivalence.

  • Authors : Hussain AS; The National Institute of Pharmaceutical Technology and Education (NIPTE), Inc., Minneapolis, Minnesota, 55414, USA.; Arnold and Marie Schwartz College of Pharmacy and Health Sciences, 75 DeKalb Avenue, Room WL 313, Brooklyn, New York, 11201, USA.

Subjects: Pharmaceutical Preparations* ; Therapeutic Equivalency*; Administration, Intranasal

  • Source: AAPS PharmSciTech [AAPS PharmSciTech] 2019 Mar 12; Vol. 20 (3), pp. 140. Date of Electronic Publication: 2019 Mar 12.Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932

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Academic Journal

Comparison of non-compartmental and mixed effect modelling methods for establishing bioequivalence for the case of two compartment kinetics and censored concentrations.

  • Authors : Hughes JH; School of Pharmacy and Medical Sciences, Australian Centre for Pharmacometrics and Sansom Institute, University of South Australia, Adelaide, SA, 5000, Australia. .; Upton RN

Subjects: Pharmacokinetics* ; Therapeutic Equivalency*; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*metabolism

  • Source: Journal of pharmacokinetics and pharmacodynamics [J Pharmacokinet Pharmacodyn] 2017 Jun; Vol. 44 (3), pp. 233-244. Date of Electronic Publication: 2017 Feb 13.Publisher: Springer Country of Publication: United States NLM ID: 101096520 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Ratio of means vs. difference of means as measures of superiority, noninferiority, and average bioequivalence.

  • Authors : Sun W; a FDA/CDER/OTS/Office of Biostatistics/Division VIII , Silver Spring , Maryland , USA.; Grosser S

Subjects: Research Design* ; Therapeutic Equivalency*; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*standards

  • Source: Journal of biopharmaceutical statistics [J Biopharm Stat] 2017; Vol. 27 (2), pp. 338-355. Date of Electronic Publication: 2016 Dec 06.Publisher: Taylor & Francis Country of Publication: England NLM ID: 9200436 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs.

  • Authors : Muñoz J; Department of Statistics, Universitat de Barcelona, Av. Diagonal 643, Barcelona, 08028, Spain.; Alcaide D

Subjects: Drug and Narcotic Control* ; Therapeutic Equivalency*; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*standards

  • Source: Statistics in medicine [Stat Med] 2016 May 30; Vol. 35 (12), pp. 1933-43. Date of Electronic Publication: 2015 Dec 28.Publisher: Wiley Country of Publication: England NLM ID: 8215016 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-0258

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Academic Journal

A new PK equivalence test for a bridging study.

  • Authors : Novick SJ; a Statistical Sciences, MedImmune LLC , Gaithersburg , Maryland , USA.; Zhang X

Subjects: Biological Availability* ; Pharmacokinetics* ; Therapeutic Equivalency*

  • Source: Journal of biopharmaceutical statistics [J Biopharm Stat] 2016; Vol. 26 (5), pp. 992-1002. Date of Electronic Publication: 2016 Feb 16.Publisher: Taylor & Francis Country of Publication: England NLM ID: 9200436 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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  • 1-10 of  350 results for ""Therapeutic Equivalency""