Results 41 to 50 of about 9,364 (186)

Generative Neural Networks for Addressing the Bioequivalence of Highly Variable Drugs

Algorithms
Bioequivalence assessment of highly variable drugs (HVDs) remains a significant challenge, as the application of scaled approaches requires replicate designs, complex statistical analyses, and varies between regulatory authorities (e.g., FDA and EMA ...
Anastasios Nikolopoulos, Vangelis D. Karalis   +1 more
doaj   +1 more source

Obesity in Classic Congenital Adrenal Hyperplasia: Mechanisms, Complications and Management

Clinical Endocrinology, EarlyView.
ABSTRACT Classic congenital adrenal hyperplasia (CCAH) is an autosomal recessive genetic disorder primarily caused by 21‐hydroxylase deficiency. Although the survival rate of patients has significantly improved with glucocorticoid replacement therapy, long‐term use of supraphysiological doses and multiple factors inherent to the disease itself have led
Jialin Mu, Yue Li, Meng Sun, Yulin Li, Panpan Li, Hui Zou   +5 more
wiley   +1 more source

Nanocarriers based therapy and diagnosis of brain diseases: cross the blood-brain barrier

Science and Technology of Advanced Materials
The blood-brain barrier (BBB) is the protective interface that isolates the central nervous system from circulating blood, which restricts approximately 98% of small molecule drugs and nearly all large molecules from entering the brain.
Lijun An, Jinwei Zhang, Xiaobo Wang, Yuanyuan Ge, Kunhui Sun, Junlin Dong, Ping Wang, Wei Li, Meifang Li, Xuelei Hu, Bing Wang, Xie-An Yu   +11 more
doaj   +1 more source

Generic drugs: myths, facts, and limitations

Italian Journal of Medicine, 2012
Bioequivalence (BE) has always been an important pharmaceutical area, particularly (but not solely) in Mediterranean region, where the use of generic drugs is a relatively recent development. The lack of new therapeutic molecules has concentrated primary
Antonio Marzo, Elisabetta Porro, Anna Barassi   +2 more
doaj   +1 more source

Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III, Active‐Controlled Study

Diabetes, Obesity and Metabolism, EarlyView.
ABSTRACT Aim To evaluate the efficacy, safety and immunogenicity of semaglutide injection (synthetic) (Test group) compared with the Reference semaglutide injection [Ozempic, (Reference group)] in Indian patients with Type 2 diabetes mellitus (T2DM).
Unnikrishnan Ambika Gopalakrishnan, Ameya Sudhakar Joshi, Richa Giri, Shalin Jagdeep Shah, Jitendra Shukla, Sanjiv Maheshwari, Rekha M. Chowdaiah, Manish Kumar Singh, Aditya Srirang Bari, Niranjan Pandurang Pathak, Akash Nitinbhai Shah, Shweta Bhandari, Ambanna Gowda, Ambrish Chandrappa, Pravin Dinkar Supe, Bharat Das, Prabhat Kumar Sharma, Mehul Kalubhai Virani, Prakash Harishchandra Kurmi, Gayatri Amit Ghanekar, Mani Deepathi Dasari, Banshidhar Sahoo, Sanjay Kumar Jangid, Prakash Sadashiv Shende, Sandesh Sahebarao Patil, Avinash Narayan Kumbhar, Shrikant Vishnu Deshpande, Madhusudhan Chennappa, Nitesh Chandubhai Patel, Dipesh Sonawane, Dipak Patil, Sucheta Pandit, Pravin Ghadge, Suyog Mehta   +33 more
wiley   +1 more source

Influence of Different Populations on Pharmacokinetic Bioequivalence Results: Can We Extrapolate Bioequivalence Results from One Population to Another?

Journal of Pharmacy & Pharmaceutical Sciences, 2020
Purpose: Over the last 15 years, an ever-increasing proportion of pharmacokinetic bioequivalence studies for European/North American generic submissions appeared to have been conducted in geographical/ethnic populations other than those for which the ...
Deniz Ozdin, Murray P. Ducharme, France Varin, Anders Fuglsang, Dina Al-Numani   +4 more
doaj   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

Pharmacokinetics of Bexagliflozin After Intravenous and Oral Administration in Cats

Journal of Veterinary Pharmacology and Therapeutics, EarlyView.
ABSTRACT Bexagliflozin, a selective sodium–glucose cotransporter 2 (SGLT2) inhibitor, has been developed for feline diabetes mellitus. This study characterized bexagliflozin pharmacokinetics in healthy cats after single intravenous and oral administrations.
Yogini Patel, Sheeva Bhattarai, Céline E. Toutain   +2 more
wiley   +1 more source

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data.

PLoS ONE, 2019
BackgroundAffordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with ...
Warren A Kaplan, Jorge Cárdenas, Cristián Mansilla, Tatiana Tobar, Veronika J Wirtz   +4 more
doaj   +1 more source

Subcutaneous Tranexamic Acid Achieves Comparable Serum Concentrations to Intramuscular Administration During Haemorrhagic Shock in a Swine Model

Acta Anaesthesiologica Scandinavica, Volume 70, Issue 6, July 2026.
ABSTRACT Background Tranexamic acid is an antifibrinolytic agent reducing mortality when administered to trauma patients with haemorrhagic shock. This mortality reduction is time sensitive. Increased intramuscular dose administration has proven an effective alternative to intravenous administration in several studies and is used by some emergency ...
Trine Lynghaug, Ole Martin Fuskevåg, Benjamin Stage Storm, Erik Waage Nielsen, Bent Aksel Nilsen, Erik Sveberg Dietrichs, Håkon Kvåle Bakke   +6 more
wiley   +1 more source