Results 51 to 60 of about 4,403,980 (152)

Development of Extended-Release Mini-Tablets Containing Metoprolol Supported by Design of Experiments and Physiologically Based Biopharmaceutics Modeling

Pharmaceutics, 2022
The development of extended-release dosage forms with adequate drug release is a challenge for pharmaceutical companies, mainly when the drug presents high solubility, as in Biopharmaceutics Classification System (BCS) class I.
Michele Georges Issa, Natalia Vieira de Souza, Bruna Wenyi Chuang Jou, Marcelo Dutra Duque, Humberto Gomes Ferraz   +4 more
doaj   +1 more source

Bioequivalence of losartan/amlodipine fixed dose combination tablets (losanet AM) compared with concomitant administration of Single components of losartan and amlodipine tablets in healthy human volunteers [PDF]

, 2017
A fixed dose combination of losartan, an angiotensin receptor blocker and amlodipine, a calcium channel blocker, can potentially provide complementary mechanism of action to improve blood pressure control and clinical outcomes.
Daccache, Elie, Feddah, Hamzeh, Bustami, Rana, Sarraf, Jean-Charles, Kyriacos, Soula, Khasawneh, Sewar, Absi, Wafaa, Mroueh, Mohamad   +7 more
core   +1 more source

Conjunction of semi-mechanistic in vitro-in vivo modeling and population pharmacokinetics as a tool for virtual bioequivalence analysis - a case study for a BCS class II drug

European Journal of Pharmaceutics and Biopharmaceutics, 2023
Virtual bioequivalence trial (VBE) simulations based on (semi)mechanistic in vitro-in vivo (IVIV) modeling have gained a huge interest in the pharmaceutical industry. Sophisticated commercially available software allows modeling variable drug fates in the gastrointestinal tract (GIT).
Dorota Danielak, Jadwiga Paszkowska, Marcela Staniszewska, Grzegorz Garbacz, Anna Terlecka, Bartłomiej Kubiak, Michał Romański   +6 more
openaire   +2 more sources

Formulation development, in vivo bioequivalence and pediatric PBPK modeling studies of taste-masked ciprofloxacin chewable tablets

Scientific Reports, 2023
A taste-masked chewable tablet of ciprofloxacin using ion exchange resin Kyron T-134 for enhancing compliance for the paediatric population was developed.
Muhammad Talha Usmani, Muhammad Harris Shoaib, Fahad Siddiqui, Farrukh Rafiq Ahmed, Rabia Ismail Yousuf, Muhammad Talha Saleem   +5 more
doaj   +1 more source

On Absorption Modeling and Food Effect Prediction of Rivaroxaban, a BCS II Drug Orally Administered as an Immediate-Release Tablet

Pharmaceutics, 2021
The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using physiologically based pharmacokinetic (PBPK) and conventional in vitro ...
Varun Kushwah, Sumit Arora, Miklós Tamás Katona, Dattatray Modhave, Eleonore Fröhlich, Amrit Paudel   +5 more
doaj   +1 more source

In Vitro–In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone

Pharmaceutics, 2021
Health authorities carefully evaluate any change in the batch manufacturing process of a drug before and after regulatory approval. In the absence of an adequate in vitro–in vivo correlation (Level A IVIVC), an in vivo bioequivalence (BE) study is ...
Elena M. Tosca, Maurizio Rocchetti, Elena Pérez, Conchi Nieto, Paolo Bettica, Jaime Moscoso del Prado, Paolo Magni, Giuseppe De Nicolao   +7 more
doaj   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

600 mg Oxcarbazepine Tablets Bioequivalence Study

, 2017
4 páginasBioequivalence studies are evidence of generic drugs quality, demonstrating that the rate and quantity of effective substance absorbed from each of the studied formulations, showed no significant differences. The aim of the pharmacokinetic study
Vargas, M., Villarraga, EA
core   +1 more source

Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers

, 2016
4 páginasThis is a pharmacokinetic test of two formulations that contain 20 mg of Isotretinoin, with the aim to compare the bioavailability between the Test Product (Isoface® from Procaps Laboratory SA, Colombia) and the Reference Product (Roaccutane ...
Batista M., Vargas Malagón, Mauricio, Mantilla P., Villarraga E., Montenegro L.   +4 more
core   +1 more source

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

CPT: Pharmacometrics & Systems Pharmacology, 2021
Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou, Andrew Babiskin, Liang Zhao   +2 more
doaj   +1 more source