Cargando…

Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and quantitative (Q2) similarity. The present study h...

Descripción completa

Detalles Bibliográficos
Autores principales:	Ren, Ping, Chan, Theresa, Yang, Wen-Cheng, Frost, Mitchell, Wang, Yan, Luke, Markham, Kim, Myong-Jin, Lionberger, Robert, Zhang, Yi
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2023
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10534858/ https://www.ncbi.nlm.nih.gov/pubmed/37765334 http://dx.doi.org/10.3390/pharmaceutics15092366

Ejemplares similares

Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations
por: Belayneh, Anteneh, et al.
Publicado: (2020)

Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets
por: Arafat, Mosab, et al.
Publicado: (2023)

Effects of polyol excipient stability during storage and use on the quality of biopharmaceutical formulations
por: Sun, Min-Fei, et al.
Publicado: (2022)

Regional Intestinal Drug Absorption: Biopharmaceutics and Drug Formulation
por: Dahan, Arik, et al.
Publicado: (2021)

Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants
por: Zarmpi, Panagiota, et al.
Publicado: (2020)

Comprehensive Assessment of Protein and Excipient Stability in Biopharmaceutical Formulations Using (1)H NMR Spectroscopy
por: Bramham, Jack E., et al.
Publicado: (2020)

Scientific and Regulatory Considerations for the Approval of the First Generic Glucagon
por: Pang, Eric, et al.
Publicado: (2021)

Sampling times and genotyping concerns in bioequivalence evaluation of branded and generic formulations
por: Zhao, Xiao-Ying, et al.
Publicado: (2013)

Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties: Case Study—Hypromellose (HPMC)
por: Zarmpi, P., et al.
Publicado: (2020)

Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs
por: Hammami, Muhammad M., et al.
Publicado: (2017)

Bioequivalence of Orally Administered Generic, Compounded, and Innovator‐Formulated Itraconazole in Healthy Dogs
por: Mawby, D.I., et al.
Publicado: (2013)

Three-dimensional aspects of formulation excipients in drug discovery: a critical assessment on orphan excipients, matrix effects and drug interactions
por: Veeravalli, Vijayabhaskar, et al.
Publicado: (2020)

Computational Prediction of Drug Solubility in Lipid Based Formulation Excipients
por: Persson, Linda C., et al.
Publicado: (2013)

Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration
por: Jiao, Kuo, et al.
Publicado: (2019)

Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers
por: Schnaars, Yvonne, et al.
Publicado: (2022)

Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients
por: González-Álvarez, Isabel, et al.
Publicado: (2022)

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report
por: Walenga, Ross L., et al.
Publicado: (2022)

Anaphylaxis to drug excipients
por: Pfützner, Wolfgang
Publicado: (2022)

Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers
por: Isnawati, Ani, et al.
Publicado: (2023)

Bioequivalence assessment of two formulations of ibuprofen
por: Al-Talla, Zeyad A, et al.
Publicado: (2011)

Application of Antisolvent Precipitation Method for Formulating Excipient-Free Nanoparticles of Psychotropic Drugs
por: Wu, Carina Yeeka, et al.
Publicado: (2022)

Trends in US approvals: new biopharmaceuticals and vaccines
por: Reichert, Janice M.
Publicado: (2006)

Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-Infected Ugandan Adults
por: Byakika-Tusiime, Jayne, et al.
Publicado: (2008)

Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review
por: van der Meersch, Amélie, et al.
Publicado: (2011)

Bioequivalence, Drugs with Narrow Therapeutic Index and the Phenomenon of Biocreep: A Critical Analysis of the System for Generic Substitution
por: Gozzo, Lucia, et al.
Publicado: (2022)

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%
por: Tsakalozou, Eleftheria, et al.
Publicado: (2021)

Safety and efficacy of generic drugs with respect to brand formulation
por: Gallelli, Luca, et al.
Publicado: (2013)

Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
por: Zhang, X, et al.
Publicado: (2017)

Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus
por: Gantar, Kaja, et al.
Publicado: (2020)

Exploring the mucoadhesive behavior of sucrose acetate isobutyrate: a novel excipient for oral delivery of biopharmaceuticals
por: Harloff-Helleberg, Stine, et al.
Publicado: (2019)

Topiramate in an Experimental Model of Epilepsy - Similarity between Generic, Similar and Reference Drugs
por: Malveira, George Linard Silva, et al.
Publicado: (2022)

Excipient-excipient interactions in the development of nanocarriers: an innovative statistical approach for formulation decisions
por: Beraldo-de-Araújo, Viviane Lucia, et al.
Publicado: (2019)

Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
por: Kesselheim, Aaron S., et al.
Publicado: (2016)

New allergy drug excipient allergy
por: Shah, Vipulkumar
Publicado: (2014)

Effects of Drugs and Excipients on Hydration Status
por: Puga, Ana M., et al.
Publicado: (2019)

Pharmaceutical excipients and the information on drug labels
por: Balbani, Aracy Pereira Silveira, et al.
Publicado: (2015)

Bioequivalence of generic and branded amoxicillin capsules in healthy human volunteers
por: Pathak, Priyanka, et al.
Publicado: (2017)

Microcrystalline Cellulose Extracted from Native Plants as an Excipient for Solid Dosage Formulations in Drug Delivery
por: Viera-Herrera, Camila, et al.
Publicado: (2020)

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects
por: Tang, Fang, et al.
Publicado: (2016)

Anionic and Ampholytic High-Amylose Starch Derivatives as Excipients for Pharmaceutical and Biopharmaceutical Applications: Structure-Properties Correlations
por: Labelle, Marc-André, et al.
Publicado: (2023)

Cannot write session to /tmp/vufind_sessions/sess_0k20sjmp6u6o040lpn3p1j8tio