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1

Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base

García-Arieta, Alfredo, Ferrero-Cafiero, Juan Manuel, Puntes, Montse, Gich, Ignasi, Morales-Alcelay, Susana, Tarré, Maite, Font, Xavier, Antonijoan, Rosa Maria

Journal:

Year:

2016

Language:

english

File:

PDF, 129 KB

english, 2016

2

Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic products

Alfredo García-Arieta, Susana Morales-Alcelay, Marta Herranz, José María de la Torre-Alvarado, Antonio Blázquez-Pérez, Mª Luisa Suárez-Gea, Covadonga Álvarez

Journal:

International Journal of Pharmaceutics

Year:

2012

Language:

english

File:

PDF, 190 KB

english, 2012

3

Agitation Rate and Time for Complete Dissolution in BCS Biowaivers Based on Investigation of a BCS Biowaiver for Dexketoprofen Tablets

Garcia-Arieta, Alfredo, Gordon, John, Gwaza, Luther, Mangas-Sanjuan, V., Álvarez, Covadonga, Torrado, Juan J.

Journal:

Molecular Pharmaceutics

Year:

2015

Language:

english

File:

PDF, 1.43 MB

english, 2015

4

Computer simulations for bioequivalence trials: Selection of analyte in BCS class II and IV drugs with first-pass metabolism, two metabolic pathways and intestinal efflux transporter

Mangas-Sanjuan, V., Navarro-Fontestad, C., García-Arieta, A., Trocóniz, I.F., Bermejo, M.

Journal:

European Journal of Pharmaceutical Sciences

Year:

2018

Language:

english

File:

PDF, 3.84 MB

english, 2018

5

Spray-Dried Powders as Nasal Absorption Enhancers of Cyanocobalamin.

GARCÍA-ARIETA, Alfredo, TORRADO-SANTIAGO, Santiago, GOYA, Luis, TORRADO, Juan José

Journal:

Biological & Pharmaceutical Bulletin

Year:

2001

Language:

english

File:

PDF, 262 KB

english, 2001

6

Comparison of free software platforms for the calculation of the 90% confidence interval of f2 similarity factor by bootstrap analysis

Noce, L., Gwaza, L., Mangas-Sanjuan, V., Garcia-Arieta, A.

Journal:

European Journal of Pharmaceutical Sciences

Year:

2020

File:

PDF, 991 KB

2020

7

Defining level A IVIVC dissolution specifications based on individual in vitro dissolution profiles of a controlled release formulation

González-García, I., García-Arieta, A., Merino-Sanjuan, M., Mangas-Sanjuan, V., Bermejo, M.

Journal:

European Journal of Pharmaceutical Sciences

Year:

2018

Language:

english

File:

PDF, 4.53 MB

english, 2018

8

Computer simulations of bioequivalence trials: Selection of design and analyte in BCS drugs with first-pass hepatic metabolism: Linear kinetics (I)

Carlos Fernández-Teruel, Ricardo Nalda Molina, Isabel González-Alvarez, Carmen Navarro-Fontestad, Alfredo García-Arieta, Vicente G. Casabó, Marival Bermejo

Journal:

European Journal of Pharmaceutical Sciences

Year:

2009

Language:

english

File:

PDF, 1.02 MB

english, 2009

9

Investigating the discriminatory power of BCS-biowaiver in vitro methodology to detect bioavailability differences between immediate release products containing a class I drug.

Colon Useche, Sarin, Gonzalez Alvarez, Isabel, Mangas Sanjuan, Victor, Gonzalez Alvarez, Marta, Pastoriza, Pilar, Molina Martinez, Irene, Bermejo, Marival, Garcia-Arieta, Alfredo

Journal:

Molecular Pharmaceutics

Year:

2015

Language:

english

File:

PDF, 1.67 MB

english, 2015

10

Investigation on the possibility of biowaivers for ibuprofen

Covadonga Álvarez, Ignacio Núñez, Juan J. Torrado, John Gordon, Henrike Potthast, Alfredo García-Arieta

Journal:

Journal of Pharmaceutical Sciences

Year:

2011

Language:

english

File:

PDF, 202 KB

english, 2011

11

Assessment of the Regulatory Methods for the Comparison of Highly Variable Dissolution Profiles

Mangas-Sanjuan, Victor, Colon-Useche, Sarin, Gonzalez-Alvarez, Isabel, Bermejo, Marival, Garcia-Arieta, Alfredo

Journal:

The AAPS Journal

Year:

2016

Language:

english

File:

PDF, 811 KB

english, 2016

12

Computer simulations for bioequivalence trials: Selection of analyte in BCS drugs with first-pass metabolism and two metabolic pathways

Carmen Navarro-Fontestad, Isabel Gonzalez-Alvarez, Carlos Fernández-Teruel, Alfredo Garcia-Arieta, Marival Bermejo, Vicente G. Casabó

Journal:

European Journal of Pharmaceutical Sciences

Year:

2010

Language:

english

File:

PDF, 1.87 MB

english, 2010

13

Computer simulations of bioequivalence trials: Selection of design and analyte in BCS drugs with first-pass hepatic metabolism: Part II. Non-linear kinetics

Carlos Fernández-Teruel, Isabel Gonzalez-Alvarez, Carmen Navarro-Fontestad, Alfredo García-Arieta, Marival Bermejo, Vicente G. Casabó

Journal:

European Journal of Pharmaceutical Sciences

Year:

2009

Language:

english

File:

PDF, 1.20 MB

english, 2009

14

Interactions between active pharmaceutical ingredients and excipients affecting bioavailability: Impact on bioequivalence

García-Arieta, Alfredo

Journal:

European Journal of Pharmaceutical Sciences

Year:

2014

Language:

english

File:

PDF, 703 KB

english, 2014

15

Composition specification of teicoplanin based on its estimated relative bioavailability

Boix-Montañes, Antonio, Garcia-Arieta, Alfredo

Journal:

Drug Development and Industrial Pharmacy

Year:

2015

Language:

english

File:

PDF, 274 KB

english, 2015

16

Adjusted Indirect Treatment Comparison of the Bioavailability of WHO-Prequalified First-Line Generic Antituberculosis Medicines

Gwaza, L, Gordon, J, Welink, J, Potthast, H, Leufkens, H, Stahl, M, García-Arieta, A

Journal:

Clinical Pharmacology & Therapeutics

Year:

2014

Language:

english

File:

PDF, 2.82 MB

english, 2014

17

Validation of a semi-physiological model for caffeine in healthy subjects and cirrhotic patients

Cuesta-Gragera, Ana, Navarro-Fontestad, Carmen, Mangas-Sanjuan, Victor, González-Álvarez, Isabel, García-Arieta, Alfredo, Trocóniz, Iñaki F., Casabó, Vicente G., Bermejo, Marival

Journal:

European Journal of Pharmaceutical Sciences

Year:

2015

Language:

english

File:

PDF, 1.10 MB

english, 2015

18

Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid

Cuesta-Gragera, Ana, Navarro-Fontestad, Carmen, Mangas-Sanjuan, Victor, González-Álvarez, Isabel, García-Arieta, Alfredo, Trocóniz, Iñaki F., Casabó, Vicente G., Bermejo, Marival

Journal:

European Journal of Pharmaceutical Sciences

Year:

2015

Language:

english

File:

PDF, 1.57 MB

english, 2015

19

In vitro dissolution as a tool for formulation selection: Telmisartan two-step IVIVC.

Ruiz-Picazo, Alejandro, Martinez-Martinez, Mª Teresa, Colon-Useche, Sarin, Iriarte, Ramon, Sanchez-Dengra, Barbara, Gonzalez-Alvarez, Marta, Garcia-Arieta, Alfredo, Gonzalez Alvarez, Isabel, Bermejo,

Journal:

Molecular Pharmaceutics

Year:

2018

Language:

english

File:

PDF, 1.17 MB

english, 2018

20

Investigation to Explain Bioequivalence Failure in Pravastatin Immediate-Release Products

Ruiz-Picazo, Alejandro, Colón-Useche, Sarin, Perez-Amorós, Blanca, González-Álvarez, Marta, Molina-Martínez, Irene, González-Álvarez, Isabel, García-Arieta, Alfredo, Bermejo, Marival

Journal:

Year:

2019

File:

PDF, 2.11 MB

2019

21

On the Incorrect Statistical Calculations of the Kinetica Software Package in Imbalanced Designs

Morales-Alcelay, S., de la Torre de Alvarado, J. M., García-Arieta, A.

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 128 KB

english, 2015

22

Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence

Mangas-Sanjuán, Víctor, Pleguezuelos-Villa, María, Merino-Sanjuán, Matilde, Hernández, Mª Jesús, Nácher, Amparo, García-Arieta, Alfredo, Peris, Daniel, Hidalgo, Irene, Soler, Lluís, Sallan, Marta, Mer

Journal:

Year:

2019

Language:

english

File:

PDF, 1001 KB

english, 2019

23

Differences in lercanidipine systemic exposure when administered according to labelling: in fasting state and 15 minutes before food intake

Álvarez, Covadonga, Gómez, Estrella, Simón, Marta, Govantes, Carlos, Guerra, Pedro, Frías, Jesús, García-Arieta, Alfredo

Journal:

European Journal of Clinical Pharmacology

Year:

2012

Language:

english

File:

PDF, 123 KB

english, 2012

24

On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs

García-Arieta, Alfredo, Gordon, John, Potthast, Henrike

Journal:

Journal of Pharmaceutical Sciences

Year:

2016

Language:

english

File:

PDF, 147 KB

english, 2016

25

Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets

González-Rojano, E., Abad-Santos, F., Ochoa, D., Román, M., Marcotegui, J., Álvarez, C., Gordon, J., García-Arieta, A.

Journal:

British Journal of Clinical Pharmacology

Year:

2018

Language:

english

File:

PDF, 375 KB

english, 2018

26

In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen

Yasuhiro Tsume, Peter Langguth, Alfredo Garcia-Arieta, Gordon L. Amidon

Journal:

Biopharmaceutics & Drug Disposition

Year:

2012

Language:

english

File:

PDF, 489 KB

english, 2012

27

On the Biopharmaceutics Classification System Biowaiver of Ibuprofen

García-Arieta, Alfredo, Gordon, John, Potthast, Henrike

Journal:

Journal of Pharmaceutical Sciences

Year:

2015

Language:

english

File:

PDF, 67 KB

english, 2015

28

Interchangeability between first-line generic antiretroviral products prequalified by WHO using adjusted indirect comparisons

Gwaza, Luther, Gordon, John, Welink, Jan, Potthast, Henrike, Leufkens, Hubert, Stahl, Matthias, García-Arieta, Alfredo

Journal:

Antiviral Therapy

Year:

2016

Language:

english

File:

PDF, 281 KB

english, 2016

29

Sex-by-formulation interaction in bioequivalence trials with transdermal patches

González-Rojano, Esperanza, Marcotegui, Julio, Morales-Alcelay, Susana, Álvarez, Covadonga, Gordon, John, Abad-Santos, Francisco, García-Arieta, Alfredo

Journal:

European Journal of Clinical Pharmacology

Year:

2019

Language:

english

File:

PDF, 799 KB

english, 2019

30

Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons

Gwaza, Luther, Gordon, John, Potthast, Henrike, Welink, Jan, Leufkens, Hubert, Stahl, Matthias, García-Arieta, Alfredo

Journal:

European Journal of Clinical Pharmacology

Year:

2015

Language:

english

File:

PDF, 525 KB

english, 2015

31

On the BCS biowaivers of orally disintegrating tablets

García-Arieta, Alfredo, Gordon, John

Journal:

European Journal of Pharmaceutical Sciences

Year:

2015

Language:

english

File:

PDF, 188 KB

english, 2015

32

Letter to the editor

Alfredo García-Arieta

Journal:

Clinical Therapeutics

Year:

2009

Language:

english

File:

PDF, 55 KB

english, 2009

33

Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

Lee, Sau L., Saluja, Bhawana, García-Arieta, Alfredo, Santos, Gustavo Mendes Lima, Li, Ying, Lu, Sarah, Hou, Shuguang, Rebello, Juliet, Vaidya, Abhijit, Gogtay, Jaideep, Purandare, Shrinivas, Lyapusti

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 1.26 MB

english, 2015

34

Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

Polli, James E., Cook, Jack A., Davit, Barbara M., Dickinson, Paul A., Argenti, Domenick, Barbour, Nancy, García-Arieta, Alfredo, Geoffroy, Jean-Marie, Hartauer, Kerry, Li, Shoufeng, Mitra, Amitava, M

Journal:

The AAPS Journal

Year:

2012

Language:

english

File:

PDF, 223 KB

english, 2012

35

Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120

Gwaza, Luther, Gordon, John, Welink, Jan, Potthast, Henrike, Hansson, Henrik, Stahl, Matthias, García-Arieta, Alfredo

Journal:

European Journal of Clinical Pharmacology

Year:

2012

Language:

english

File:

PDF, 220 KB

english, 2012

36

A European Perspective on Orally Inhaled Products: In Vitro Requirements for a Biowaiver

García-Arieta, Alfredo

Journal:

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Year:

2014

Language:

english

File:

PDF, 332 KB

english, 2014

37

The failure to show bioequivalence is not evidence against generics

Alfredo García-Arieta

Journal:

British Journal of Clinical Pharmacology

Year:

2010

Language:

english

File:

PDF, 349 KB

english, 2010

38

Global Harmonization of Comparator Products for Bioequivalence Studies

Gwaza, Luther, Gordon, John, Leufkens, Hubert, Stahl, Matthias, García-Arieta, Alfredo

Journal:

The AAPS Journal

Year:

2017

Language:

english

File:

PDF, 229 KB

english, 2017

39

Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator (GIS) and Precipitation Pathways Analyses

Bermejo, Marival, Kuminek, Gislaine, Al-Gousous, Jozef, Ruiz-Picazo, Alejandro, Tsume, Yasuhiro, Garcia-Arieta, Alfredo, González-Alvarez, Isabel, Hens, Bart, Amidon, Gregory, Rodriguez-Hornedo, Nair,

Journal:

Year:

2019

Language:

english

File:

PDF, 897 KB

english, 2019

40

Comparative Study of Aqueous and Organic Enteric Coatings of Chlorpheniramine Maleate Tablets

García-Arieta, A., Torrado-Santiago, D., Torrado, J. J.

Journal:

Drug Development and Industrial Pharmacy

Year:

1996

Language:

english

File:

PDF, 418 KB

english, 1996

41

Sensitive studies with a significant dose–response curve for inhaled corticosteroids to investigate equivalent relative potency are feasible

Alfredo García-Arieta

Journal:

British Journal of Clinical Pharmacology

Year:

2011

Language:

english

File:

PDF, 401 KB

english, 2011

42

How to Compare Two Different Metered-Dose Inhaler-Valved Holding Chambers in the Administration of Salbutamol

García-Arieta, Alfredo

Journal:

Year:

2010

Language:

english

File:

PDF, 98 KB

english, 2010

43

A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme

Van Oudtshoorn, Joy Elizabeth, García-Arieta, Alfredo, Santos, Gustavo Mendes Lima, Crane, Christopher, Rodrigues, Clare, Simon, Craig, Kim, Ji Myoung, Park, Sang Aeh, Okada, Yusuke, Kuribayashi, Ryos

Journal:

Journal of Pharmacy and Pharmaceutical Sciences

Year:

2018

Language:

english

File:

PDF, 301 KB

english, 2018

44

Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies

Juan José Torrado, María Blanco, Magí Farré, Pere Roset, Alfredo García-Arieta

Journal:

European Journal of Clinical Pharmacology

Year:

2010

Language:

english

File:

PDF, 153 KB

english, 2010

45

About the equivalence between different batches of a glycopeptide drug

Boix-Montañes, Antonio, Garcia-Arieta, Alfredo

Journal:

Pharmaceutical Development and Technology

Year:

2015

Language:

english

File:

PDF, 123 KB

english, 2015

46

An eutomer/distomer ratio near unity does not justify non-enantiospecific assay methods in bioequivalence studies

Alfredo García-Arieta, Francisco Abad-Santos, M. Angeles Rodríguez-Martínez, Yolanda Varas-Polo, Jesús Novalbos, Nikos Laparidis, Sonia Gallego-Sandín, Kyriakos Orfanidis, Juan Torrado

Journal:

Year:

2005

Language:

english

File:

PDF, 87 KB

english, 2005

47

A multivariate investigation into the relationship between pharmaceutical characteristics and patient preferences of bioequivalent ibuprofen tablets

Alonso Cuenca, Tatiana del Rosario, Gagol, Adrianna, Scherer, Maximilian, Matji, Antonio, Torrado-Santiago, Santiago, Serrano, Dolores R, García-Arieta, Alfredo, Torrado, Juan

Journal:

Patient Preference and Adherence

Year:

2018

Language:

english

File:

PDF, 876 KB

english, 2018

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