نتائج البحث

Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects.

• Authors : Althunian, Turki A.^1,2 (AUTHOR) ; Alzenaidy, Bader R.³ (AUTHOR); Alroba, Raseel A.¹ (AUTHOR)

• Source: BMC Medical Research Methodology. 4/5/2024, Vol. 24 Issue 1, p1-10. 10p.

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Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects

• Authors : Turki A. Althunian; Bader R. Alzenaidy; Raseel A. Alroba

Subjects: Bioequivalence trials; Clinical trials; Generic drugs

• Source: BMC Medical Research Methodology, Vol 24, Iss 1, Pp 1-10 (2024)

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Genetic variation in UGT1A1 is not associated with altered liver biochemical parameters in healthy volunteers participating in bioequivalence trials

• Authors : Eva González-Iglesias; Dolores Ochoa; Manuel Román

Subjects: Bioequivalence trials; genetics; UGT1A1 gene

• Source: Frontiers in Pharmacology, Vol 15 (2024)

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Proposing some innovative study design features to regulatory agencies (EMA and FDA) in bioequivalence trials : Reference Scaled Average Bioequivalence, and Two-Stage Adaptive Designs

• Authors : Molins Lleonart, Eduard; University/Department: Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa

Subjects: Àrees temàtiques de la UPC::Matemàtiques i estadística

• Source: TDX (Tesis Doctorals en Xarxa)

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Genetic variation in UGT1A1 is not associated with altered liver biochemical parameters in healthy volunteers participating in bioequivalence trials

• Authors : González-Iglesias, Eva; Ochoa, Dolores; Román, Manuel

• Source: Frontiers in Pharmacology ; volume 15 ; ISSN 1663-9812

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Between‐Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial

• Authors : Getz, E Burmeister; Carroll, KJ; Mielke, J

Subjects: Pharmacology and Pharmaceutical Sciences; Biomedical and Clinical Sciences; Clinical Research

• Source: Clinical Pharmacology & Therapeutics. 101(3)

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Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial.

• Authors : Burmeister Getz, E; Carroll, KJ; Mielke, J

Subjects: Humans; Bronchodilator Agents; Metabolic Clearance Rate

• Source: Clinical pharmacology and therapeutics. 101(3)

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Detection of outlying subjects in bioequivalence trials.

• Authors : Saurav, Sumeet¹; Varghese, Cini¹; Jaggi, Seema¹

Subjects: *OUTLIER detection; *BIOAVAILABILITY

• Source: Quarterly Research Journal of Plant & Animal Sciences / Bhartiya Krishi Anusandhan Patrika. Mar-Jun2020, Vol. 35 Issue 1/2, p91-93. 3p.

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A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

• Authors : Hao Zhu; Xiaomei Chen; Mariam Ahmed

Subjects: Therapeutics. Pharmacology; RM1-950; Public aspects of medicine

• Source: Clinical and Translational Science, Vol 12, Iss 6, Pp 564-572 (2019)

تفاصيل العنوان

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.

• Authors : Zhu, Hao¹ (AUTHOR) ; Chen, Xiaomei¹ (AUTHOR); Ahmed, Mariam¹ (AUTHOR)

• Source: CTS: Clinical & Translational Science. Nov2019, Vol. 12 Issue 6, p564-572. 9p.

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