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1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence

Dr Laszlo Tothfalusi, Laszlo Endrenyi, Alfredo Garcia Arieta

Journal:

Clinical Pharmacokinetics

Year:

2009

Language:

english

File:

PDF, 296 KB

english, 2009

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

Assessing bioequivalence of generic antiepilepsy drugs by indirect comparisons

Alfredo García Arieta

Journal:

Annals of Neurology

Year:

2012

Language:

english

File:

PDF, 704 KB

english, 2012

21

Reasons to use stereoselective assay methods

Alfredo Garcia Arieta

Journal:

Year:

2012

Language:

english

File:

PDF, 41 KB

english, 2012

22

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

23

Letter to the editor

Alfredo García-Arieta

Journal:

Clinical Therapeutics

Year:

2009

Language:

english

File:

PDF, 55 KB

english, 2009

24

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

25

Bioequivalence assessment of inhalation products: Interchangeability, study design and statistical methods

Alfredo García Arieta

Journal:

Pulmonary Pharmacology & Therapeutics

Year:

2010

Language:

english

File:

PDF, 116 KB

english, 2010

26

The frequent deficiency of lack of assay sensitivity

Alfredo García Arieta

Journal:

Respiratory Medicine

Year:

2007

Language:

english

File:

PDF, 142 KB

english, 2007

27

Frequent mistakes in equivalence studies of generic inhalation products

Alfredo García Arieta

Journal:

Respiratory Medicine

Year:

2008

Language:

english

File:

PDF, 145 KB

english, 2008

28

On comparing different devices of inhalation products

Alfredo García Arieta

Journal:

Respiratory Medicine

Year:

2009

Language:

english

File:

PDF, 100 KB

english, 2009

29

On the superiority of BDP/FF HFA pMDI fixed combination over the free combination of BDP CFC pMDI and FF DPI

Alfredo García Arieta

Journal:

Respiratory Medicine

Year:

2009

Language:

english

File:

PDF, 99 KB

english, 2009

30

Establishing bioequivalence for orally inhaled drug products

García Arieta, Alfredo

Journal:

Expert Opinion on Drug Delivery

Year:

2011

Language:

english

File:

PDF, 149 KB

english, 2011

31

Efficacy and safety of Flutiform compared with individual fluticasone and formoterol reference products

García Arieta, Alfredo

Journal:

Respiratory Medicine

Year:

2011

Language:

english

File:

PDF, 104 KB

english, 2011

32

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

33

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

34

Letter to the Editor

García Arieta, Alfredo

Journal:

Journal of Aerosol Medicine

Year:

2007

Language:

english

File:

PDF, 37 KB

english, 2007

35

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

36

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

37

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

38

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

39

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

40

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

41

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

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

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

44

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

45

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

46

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

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

48

A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme

Garcia Arieta, Alfredo, Simon, Craig, Lima Santos, Gustavo Mendes, Calderón Lojero, Iván Omar, Rodríguez Martínez, Zulema, Rodrigues, Clare, Park, Sang Aeh, Kim, Ji Myoung, Kuribayashi, Ryosuke, Okada

Journal:

Journal of Pharmacy and Pharmaceutical Sciences

Year:

2019

Language:

english

File:

PDF, 553 KB

english, 2019

49

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

50

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