Literature DB >> 22533559

European Medicines Agency guideline on bioanalytical method validation: what more is there to say?

Graeme Smith1.   

Abstract

Mesh：

Year:  2012        PMID： 22533559     DOI： 10.4155/bio.12.44

Source DB:  PubMed          Journal:  Bioanalysis        ISSN： 1757-6180            Impact factor:   2.681


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  14 in total

1.  Effect of raw material variability of glipizide on the in vitro dissolution rate and in vivo bioavailability performance: The importance of particle size.

Authors:  Chenyao Zhao; Chan Jin; Hailing Gao; Liyuan Wang; Hongzhuo Liu; Zhonggui He
Journal:  Asian J Pharm Sci       Date:  2018-08-28       Impact factor: 6.598

2.  First-in-human, randomized, double-blind, placebo-controlled, dose escalation trial of the anti-herpes simplex virus monoclonal antibody HDIT101 in healthy volunteers.

Authors:  Antje Blank; Nicolas Hohmann; Marlen Dettmer; Anette Manka-Stuhlik; Gerd Mikus; Felicitas Stoll; Marlies Stützle-Schnetz; Daniel Thomas; Evelyn Exner; Beate Schmitt-Bormann; Torsten Schaller; Rico Laage; Oliver Schönborn-Kellenberger; Michaela Arndt; Walter E Haefeli; Jürgen Krauss
Journal:  Clin Transl Sci       Date:  2022-07-23       Impact factor: 4.438

3.  Exploring Equity in Public Transportation Planning Using Smart Card Data.

Authors:  Kiarash Ghasemlou; Murat Ergun; Nima Dadashzadeh
Journal:  Sensors (Basel)       Date:  2021-04-26       Impact factor: 3.576

4.  Ex Vivo Human Skin is not a Barrier for Cyclic Siloxanes (Cyclic Silicones): Evidence of Diffusion, Bioaccumulation, and Risk of Dermal Absorption Using a New Validated GC-FID Procedure.

Authors:  Dominika Krenczkowska; Krystyna Mojsiewicz-Pieńkowska; Bartosz Wielgomas; Dagmara Bazar; Zbigniew Jankowski
Journal:  Pharmaceutics       Date:  2020-06-24       Impact factor: 6.321

5.  Quantitative determination of doxorubicin in the exosomes of A549/MCF-7 cancer cells and human plasma using ultra performance liquid chromatography-tandem mass spectrometry.

Authors:  Mohammad H Semreen; Hasan Y Alniss; Muath K Mousa; Rafaat El-Awady; Farman Khan; Khalid Abu Al-Rub
Journal:  Saudi Pharm J       Date:  2018-05-23       Impact factor: 4.330

Review 6.  Detection and quantification of Covid-19 antiviral drugs in biological fluids and tissues.

Authors:  Maria A Acquavia; Luca Foti; Raffaella Pascale; Antonia Nicolò; Vincenzo Brancaleone; Tommaso R I Cataldi; Giuseppe Martelli; Laura Scrano; Giuliana Bianco
Journal:  Talanta       Date:  2020-11-05       Impact factor: 6.057

7.  Amoxicillin and Clarithromycin Mucoadhesive Delivery System for Helicobacter pylori Infection in a Mouse Model: Characterization, Pharmacokinetics, and Efficacy.

Authors:  Isabel Villegas; María Ángeles Rosillo; Catalina Alarcón-de-la-Lastra; Victoria Vázquez-Román; Maria Llorente; Susana Sánchez; Ana Gloria Gil; Pilar Alcalde; Esther González; Elisabet Rosell; Carles Nieto; Francisco Fernandez-Campos
Journal:  Pharmaceutics       Date:  2021-01-24       Impact factor: 6.321

8.  A New Validated HPLC-MS/MS Method for Quantification and Pharmacokinetic Evaluation of Dovitinib, a Multi-Kinase Inhibitor, in Mouse Plasma.

Authors:  Haitham AlRabiah; Adnan A Kadi; Haya I Aljohar; Mohamed W Attwa; Nasser S Al-Shakliah; Sabry M Attia; Gamal Ae Mostafa
Journal:  Drug Des Devel Ther       Date:  2020-01-28       Impact factor: 4.162

9.  A Validated LC-MS/MS Assay for the Simultaneous Quantification of the FDA-Approved Anticancer Mixture (Encorafenib and Binimetinib): Metabolic Stability Estimation.

Authors:  Mohamed W Attwa; Hany W Darwish; Nasser S Al-Shakliah; Adnan A Kadi
Journal:  Molecules       Date:  2021-05-05       Impact factor: 4.411

10.  High sensitivity LC-MS profiling of antibody-drug conjugates with difluoroacetic acid ion pairing.

Authors:  Jennifer M Nguyen; Jacquelynn Smith; Susan Rzewuski; Cristina Legido-Quigley; Matthew A Lauber
Journal:  MAbs       Date:  2019-09-10       Impact factor: 5.857
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