Article
Pharmacology & Pharmacy
Simona Rizea-Savu, Simona Nicoleta Duna, Dimitrios Panagiotopoulos, Roxana Colette Sandulovici
Summary: This study presents a validated method for simultaneously determining lisdexamfetamine and dexamfetamine in human plasma, and the first published bioavailability study of lisdexamfetamine. The results show that the PK parameters of both lisdexamfetamine and dexamfetamine are within the regulatory limits, with almost identical PK parameters for dexamfetamine.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Veterinary Sciences
Yuxin Yang, Jingyuan Kong, Yu Liu, Qinyao Wu, Yuying Cao, Jicheng Qiu, Lu Zhang, Xiaohui Gong, Fuhua Zhao, Xingyuan Cao, Jianzhong Wang
Summary: This study investigated the pharmacokinetic profiles and bioequivalence of two cyclosporine oral solutions in cats. The results showed no significant differences in major pharmacokinetic parameters between the two formulations and the blood profiles of cyclosporine were similar after administration.
FRONTIERS IN VETERINARY SCIENCE
(2022)
Article
Chemistry, Multidisciplinary
A. De Simone, L. Davani, S. Montanari, V Tumiatti, S. Avanessian, F. Testi, V Andrisano
Summary: By combining a standard dissolution test with an optimized PAMPA, the study revealed significant differences in release and absorption rates between generic and brand-name LVN tablets, explaining the unbalanced in vivo bioequivalence. This new approach provided important insights into prediction of in vivo BE of drugs.
FRONTIERS IN CHEMISTRY
(2021)
Article
Pharmacology & Pharmacy
Benny M. Amore, Nikunjkumar Patel, Priya Batheja, Ian E. Templeton, Hannah M. Jones, Michael J. Louie, Maurice G. Emery
Summary: The bioequivalence of bempedoic acid oral suspension and commercial immediate release (IR) tablet formulations was assessed using a physiologically based pharmacokinetic (PBPK) model. The model was developed based on clinical mass balance results, in vitro data, and verified against observed clinical pharmacokinetics (PK) results. The model simulations predicted that there are unlikely to be clinically meaningful differences between the oral suspension and IR tablet in terms of bempedoic acid absorption.
Article
Medicine, Research & Experimental
Anna-Kaisa Rimpela, Yunhai Cui, Achim Sauer
Summary: The study developed a mechanistic model that combines the diffusion rate of small molecules in the vitreous and permeability across posterior segment tissues to predict vitreal clearance. The specific dimensions of the human eye allow the model to accurately predict human vitreal clearance.
MOLECULAR PHARMACEUTICS
(2021)
Editorial Material
Chemistry, Medicinal
Melissa Metry, Yan Shu, Bertil Abrahamsson, Rodrigo Cristofoletti, Jennifer B. Dressman, D. W. Groot, Alan Parr, Peter Langguth, Vinod P. Shah, Tomokazu Tajiri, Mehul U. Mehta, James E. Polli
Summary: The study evaluates the possibility of waiving in vivo bioequivalence testing for metformin based on its BCS classification and dissolution rate. Despite being a transporter-mediated drug, common excipients have little impact on metformin absorption.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Pharmacology & Pharmacy
Isabel Gonzalez-alvarez, Barbara Sanchez-Dengra, Raquel Rodriguez-Galvez, Alejandro Ruiz-Picazo, Marta Gonzalez-alvarez, Alfredo Garcia-Arieta, Marival Bermejo
Summary: In the past, excipients were considered unimportant in the absorption process, but research has shown that this belief is not always true. This study investigated the reasons for a bioequivalence failure between two formulations of silodosin and found that the differences in excipients can indeed affect the drug's permeability through the gastrointestinal barrier.
Article
Pharmacology & Pharmacy
Xu Zuo, Xin Zhao, Tiandong Zhang
Summary: This study evaluated the bioequivalence of two methotrexate tablets under fasting and fed conditions and found that they were bioequivalent in both conditions. No serious adverse reactions or events were observed.
NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
(2023)
Article
Chemistry, Medicinal
Wanjun Bai, Haojing Song, Yiting Hu, Xueyuan Zhang, Xiaoru Wang, Caihui Guo, Bo Qiu, Zhanjun Dong
Summary: This study compared the pharmacokinetics and safety of generic and original vortioxetine hydrobromide tablets under fasting and fed conditions. The results showed that the pharmacokinetic parameters of the test drug were similar to those of the reference drug, indicating bioequivalence. Both formulations were safe and well-tolerated in healthy Chinese subjects.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2023)
Article
Chemistry, Medicinal
Jin Wang, Huan Zhang, Rui Wang, Yun Cai
Summary: In this study, the pharmacokinetics, bioequivalence and safety profiles of 90 mg ticagrelor tablets and their active metabolite were evaluated in healthy Chinese subjects under fasting and fed conditions. The results showed no significant differences in PK parameters and bioequivalence between the test and reference drugs, with no severe adverse events observed.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Review
Pharmacology & Pharmacy
Prajakta P. Patil, Atmaram P. Pawar, Kakasaheb R. Mahadik, Vinod L. Gaikwad
Summary: There are various regulatory recommendations on bioequivalence assessment for locally acting OIDPs published by global regulatory authorities, with different approaches such as aggregated weight of evidence and stepwise approach. Currently, there is no universally adopted methodology for OIDPs, and global harmonization of regulatory guidance has not been achieved. Understanding and comparing bioequivalence recommendations from different regions can lead to more sensitive and cost-effective evaluation methods, ultimately providing more safe and effective generic OIDPs to the public.
EXPERT OPINION ON DRUG DELIVERY
(2021)
Article
Pharmacology & Pharmacy
Gang Mai, Lianlian Fan, Mupeng Li, Peiwen Zhang, Chunyan Gan, Qian Huang, Jianzhong Shentu
Summary: The study demonstrated pharmacokinetic similarity between LRG201902 and Victoza(R) in healthy subjects, with comparable safety and immunogenicity profiles in the two products.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Chemistry, Medicinal
Chunqi Huang, Zhou Yin, Yeqing Yang, Nan Mo, Hui Yang, Ying Wang
Summary: The purpose of this study was to explore the pharmacokinetics, bioequivalence, food effect, and safety of oral ibuprofen sustained-release capsules from two different sponsors. The findings showed that ibuprofen had a favorable safety profile and achieved bioequivalence under both fasting and fed conditions.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2023)
Article
Chemistry, Medicinal
Qiuying Li, Lihui Jia, Wenli Hu, Shu Dong, Chaohong Cai
Summary: The study evaluated the bioequivalence and safety of two formulations of 25 mg tenofovir alafenamide tablets in Chinese healthy male and female subjects under fed and fasting conditions. The results showed that both formulations met the bioequivalence acceptance criteria and were well tolerated by the subjects, demonstrating bioequivalence in pharmacokinetic parameters under different feeding conditions.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Medicine, Research & Experimental
Chen-Jing Wang, Ting Li, Ping-Ping Lin, Ye Tao, Xin Jiang, Xin Li, Qing Wen, Yu Cao
Summary: This study assessed the pharmacokinetics, bioequivalence, and safety of 150 mg capecitabine compared to the branded reference formulation in colorectal or breast cancer patients receiving a high-fat diet. The test formulation was found to be bioequivalent and well tolerated under fed conditions.
ADVANCES IN THERAPY
(2021)