Search Results - "Garcia Arieta, Alfredo"

The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities by Fernandes, Eduardo Agostinho Freitas, van Oudtshoorn, Joy, Tam, Andrew, González, Liliana Carolina Arévalo, Aurela, Erwin Guzmán, Potthast, Henrike, Mettke, Katalina, Kuribayashi, Ryosuke, Shimojo, Kohei, Kasuga, Miho, Morales, Lázaro, Rodríguez, Zulema, Jones, Ben, Ahn, Choongyul, Yun, Eunju, Kim, So Hee, Rodrigues, Clare, Tiong, Toh, Crane, Christopher, Walther, Chantal, Roost, Matthias S, Chen, Tzu-Ling, Hsu, Li-Feng, Braddy, April C, García-Arieta, Alfredo, Abalos, Ivana, Divinsky, Milly, Alsuwyeh, Abdulaziz, Alzenaidy, Bader, Alharf, Adel

“…Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently…”
Get full text

Effect of enantiomerism on the bioequivalence of a new ibuprofen 600‐mg tablet formulation obtained by roller compaction by Matji, Antonio, Vargas, Emilio, Carvajal, Luis, Terleira, Ana Isabel, Portolés, Antonio, Garcia‐Arieta, Alfredo, Torrado, Juan J., Serrano, Dolores R.

“…The bioequivalence of a new ibuprofen 600‐mg film‐coated tablet obtained by roller compaction was studied in a crossover study with 22 healthy volunteers…”
Get full text

A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme by Tam, Andrew, Garcia-Arieta, Alfredo, Abalos, Ivana, Agostinho Freitas Fernandes, Eduardo, Mendes Lima Santos, Gustavo, Rodriguez Martinez, Zulema, Divinsky, Milly, Kariv, Rami, Potthast, Henrike, Braddy, April C, Rodrigues, Clare, Guzman Aurela, Erwin, Carolina Arevalo Gonzalez, Liliana, Gutierres Triana, Diego, Jones, Ben, Ahn, Choongyul, Kim, Hyuna, Kim, So Hee, Kuribayashi, Ryosuke, Myoenzono, Aya, Shimojo, Kohei, Van Oudtshoorn, Joy, Bigler, Cornelia, Meincke, Ricarda, Roost, Matthias S, Walther, Chantal, Hsu, Li-Feng, Crane, Christopher, Jarman, Tony

“…The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is…”
Get full text

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications by Lenić, Ines, Blake, Kevin, Garcia‐Arieta, Alfredo, Potthast, Henrike, Welink, Jan

“…The waiver of the in vivo demonstration of bioequivalence (biowaiver) is an established tool in drug development and regulatory assessment. This study reviews…”
Get full text

A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme by Garcia Arieta, Alfredo, Simon, Craig, Tam, Andrew, Mendes Lima Santos, Gustavo, Freitas Fernandes, Eduardo Agostinho, Rodríguez Martínez, Zulema, Rodrigues, Clare, Park, Sang Aeh, Kim, JaYoung, Kim, Kwansoo, Kuribayashi, Ryosuke, Myoenzono, Aya, Shimojo, Kohei, Walther, Chantal, Roost, Matthias S, Hung, Wen-Yi, Hsu, Li-Feng, Crane, Christopher, Braddy, April C, Van Oudtshoorn, Joy, Gutierrez Triana, Diego Alejandro, Guzmán Aurela, Erwin, Jones, Ben, Potthast, Henrike, Abalos, Ivana

“…The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System…”
Get full text

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 by 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, Ryosuke, Pfäffli, Chantal, Nolting, Arno, Lojero, Iván Omar Calderón, Martínez, Zulema Rodríguez, Hung, Wen-Yi, Braddy, April C, Leal, Nancy Arciniegas, Triana, Diego Gutierrez, Clarke, Mitch, Bachmann, Peter

“…The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in…”
Get full text

The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities by Crane, Christopher, Santos, Gustavo Mendes Lima, Fernandes, Eduardo Agostinho Freitas, Simon, Craig, Tam, Andrew, Triana, Diego Gutierrez, Potthast, Henrike, Kuribayashi, Ryosuke, Okada, Yusuke, Myoenzono, Aya, Calderon, Ivan Omar, Rodriguez, Zulema, Jones, Ben, Park, Sang Aeh, Eum, So Young, Rodrigues, Clare, Van Oudsthoorn, Joy, Nolting, Arno, Walther, Chantal, Roost, Matthias S, Hung, Wen-Yi, Braddy, April C, Garcia-Arieta, Alfredo

“…In relation to the registration of generic products, waivers of in vivo bioequivalence studies (biowaivers) are considered in three main cases: certain dosage…”
Get full text

Establishing bioequivalence for orally inhaled drug products by Arieta, Alfredo García

Get more information

Interactions between active pharmaceutical ingredients and excipients affecting bioavailability: Impact on bioequivalence by García-Arieta, Alfredo

“…The aim of the present paper is to illustrate the impact that excipients may have on the bioavailability of drugs and to review existing US-FDA, WHO and EMA…”
Get full text

Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence by Tothfalusi, Laszlo, Endrenyi, Laszlo, Arieta, Alfredo Garcia

“…Bioequivalence studies are performed to demonstrate in vivo that two pharmaceutically equivalent products (in the US) or alternative pharmaceutical products…”
Get full text

In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen by Tsume, Yasuhiro, Langguth, Peter, Garcia-Arieta, Alfredo, Amidon, Gordon L.

“…ABSTRACT The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate‐release…”
Get full text

Assessing bioequivalence of generic antiepilepsy drugs by indirect comparisons by Garcia Arieta, Alfredo

Get full text

Assessment of the Regulatory Methods for the Comparison of Highly Variable Dissolution Profiles by Mangas-Sanjuan, Victor, Colon-Useche, Sarin, Gonzalez-Alvarez, Isabel, Bermejo, Marival, Garcia-Arieta, Alfredo

“…The objective is to compare the performance of dissolution-profile comparison methods when f 2 is inadequate due to high variability. The 90% confidence region…”
Get full text

Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia by Pejčić, Zorica, Vučićević, Katarina, García‐Arieta, Alfredo, Miljković, Branislava

“…Aims Generic products can be regarded as therapeutically equivalent and switchable with the reference product. However, switchability between generics is…”
Get full text

A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms by Reig-López, Javier, Merino-Sanjuan, Matilde, García-Arieta, Alfredo, Mangas-Sanjuán, Victor

“…Atorvastatin is the most prescribed 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor used to lower cardiovascular risk and constitutes one of the…”
Get full text

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective by Manolis, Efthymios, García‐Arieta, Alfredo, Lindahl, Anders, Kotzagiorgis, Evangelos, Limberg, Jobst, Holte, Øyvind, Paixao, Paulo, Versantvoort, Carolien, Tshinanu, Flora Musuamba, Blake, Kevin, Van Den Heuvel, Michiel

“…In the Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms, 6 the in vitro–in vivo correlation (IVIVC) framework is…”
Get full text

Investigation on the Existence of Sex‐By‐Formulation Interaction in Bioequivalence Trials by González‐Rojano, Esperanza, Marcotegui, Julio, Ochoa, Dolores, Román, Manuel, Álvarez, Covadonga, Gordon, John, Abad‐Santos, Francisco, García‐Arieta, Alfredo

“…The US Food and Drug Administration recommends that if a drug product is intended for use in both sexes, similar proportions should be recruited for…”
Get full text

On the Biopharmaceutics Classification System Biowaiver of Ibuprofen by García-Arieta, Alfredo, Gordon, John, Potthast, Henrike

Get more information

A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union by Paixao, Paulo, Garcia Arieta, Alfredo, Silva, Nuno, Petric, Zvonimir, Bonelli, Milton, Morais, José Augusto Guimarães, Blake, Kevin, Gouveia, Luís Filipe

“…In the European Union, bioequivalence (BE) for narrow therapeutic index (NTI) drugs is currently demonstrated when the 90% confidence interval for the ratio of…”
Get full text

Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen by González‐Rojano, Esperanza, Marcotegui, Julio, Laredo, Leonor, Gwaza, Luther, Gordon, John, Portolés, Antonio, Vargas, Emilio, Morales‐Alcelay, Susana, García‐Arieta, Alfredo

“…According to the Ibuprofen Product‐Specific Bioequivalence Guidance of the European Medicines Agency, achiral bioanalytical methods are considered acceptable…”
Get full text