Results 51 to 60 of about 80,706 (309)

Standardizing bioequivalence administration methods for chewable tablets: aligning product-specific guidance with current FDA recommendations

AAPS Open
This paper examines the standardization of bioequivalence (BE) administration methods for chewable tablets and other dosage forms instructing chewing in alignment for generic drug development.
Hye Lim Lim, Heather Boyce, Qi Zhang, Myong-Jin Kim, Wei-Jhe Sun   +4 more
doaj   +1 more source

In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products

CPT: Pharmacometrics & Systems Pharmacology, 2019
The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing ...
Ross L. Walenga, Andrew H. Babiskin, Liang Zhao   +2 more
doaj   +1 more source

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug ...
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao   +17 more
doaj   +1 more source

Water Permeates and Plasticizes Amorphous Carbon Dots: Unraveling the Inner Accessibility of the Nanoparticles by Glass Transition Studies

Advanced Materials, EarlyView.
The water permeability of amorphous carbon dots (CDs) is demonstrated by investigating their plasticization. Novel polyamide‐based and amorphous nanoparticles are synthesized by controlling their inner packing density. Water plasticization is evidenced by the decrease of the CDs glass transition temperature with increasing the hydration degree.
Elisa Sturabotti, Valerio Di Lisio, Lucia Cardo, Alessandro Camilli, Estela Moretón Alfonsín, Daniele Cangialosi, Amaia Iturrospe Ibarra, Arantxa Arbe, Maurizio Prato   +8 more
wiley   +1 more source

Evaluation between the Usability and Physicochemical Property of Acyclovir Ointments [PDF]

, 2018
A lot of prescription medicines have become switch over-the-counter (OTC) medicines. However, additives in brand-name drugs, generic drugs, and switch OTC drugs differ; therefore, the feelings associated with the use of thesemedicines vary for patients ...
村田, 勇, 篠原, 壱佳, 三森, 秋穂, 鳴海, 祥恵, 井上, 裕, 金本, 郁男   +5 more
core   +1 more source

Generic drugs: benefit/risk ratio

Неврология, нейропсихиатрия, психосоматика, 2021
The review discusses the interchangeability of medications, approaches to the registration of original and generic drugs, and types of their equivalence, as well as problems with generics in clinical practice.
E. A. Ushkalova, S. K. Zyryanov, I. A. Gopienko   +2 more
doaj   +1 more source

Chiral Microneedle Arrays With Terahertz Chiroptical Activity With Chiral‐Plasmon‐Chiral‐Phonon Resonance

Advanced Materials, EarlyView.
ABSTRACT Microneedle arrays (MNAs) is a rapidly emerging technology with broad biomedical applications in drug delivery and biosensing. With sub‐millimeter dimensions and periodicity, MNAs possess geometries nearly ideal for biomedical devices operating within the terahertz (THz) spectral window.
Sang Hyun Lee, Hong Ju Jung, John Kim, Bum Chul Park, Caio V. C. R. da Silva, André F. de Moura, Nicholas A. Kotov   +6 more
wiley   +1 more source

Discrepancies Between Medical and Pharmacy Records for Patients on Anti-HIV Drugs

, 2002
OBJECTIVE: To compare and evaluate drug notations in outpatient medical records and in pharmacy records in a cohort of HIV-1-infected patients treated with antiretroviral drugs.
Frankfort, Suzanne V, Koks, Cornelis H W, de Boer, Anthonius, van Gorp, Eric C M, Beijnen, Jos H., Mathôt, Ron A A, Dep Farmaceutische wetenschappen, de Maat, Monique M. R., Frankfort, Suzanne V., Mulder, Jan W, Hoetelmans, Richard M W, Sub Pharmacotherapy, Theoretical, Mathôt, Ron A. A., Meenhorst, Pieter L., de Maat, Monique M R, Meenhorst, Pieter L, Sub Clinical Pharmacology, Mulder, Jan W., Beijnen, Jos H, van Gorp, Eric C. M., Hoetelmans, Richard M. W., Koks, Cornelis H. W.   +21 more
core   +1 more source

Mechanism‐Driven Nanoformulations for Cognitive Impairment Induced by Intermittent Hypoxia and Periodontitis

Advanced Materials, EarlyView.
Clinically, intermittent hypoxia (IH) is often accompanied by periodontitis, which accelerates cognitive impairment induced by IH. Novel Janus mesoporous gold‐silica nanoformulations (RVG‐Au&mSiO2‐TPP‐VB) enable intranasal delivery, achieve hierarchical targeting to neuronal mitochondria, effectively scavenge reactive oxygen species, inhibit the HIF‐1α/
Kai‐Run Zhang, Tianbao Zhu, An‐Qi Liu, Jia‐Jia Deng, Ya‐Li Han, Sheng‐Cai Qi, Xue Liu, Tian‐Yi Jiang, Ming‐Rui Zhai, Yu‐Ying He, Xiu‐Juan Li, Hong‐Ting Da, Rui Xu, Xiaomin Li, Jun Gao, Yue‐Hua Liu   +15 more
wiley   +1 more source

Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review [PDF]

, 2017
Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries.Methods: A questionnaire-based survey was performed in the period
Turcu-Stiolica, Adina,, Rugaja, Zinta,, Rugaja, Z, Zinta Rugaja, Draganic, Pero, Manova, M, Pilc, Andrzej,, Pilc, Andrzej, Stawowczyk, Ewa, Sowada, C, Agnes Männik, Sowada, Christoph,, Kawalec, Paweł, Inotai, Andras, Männik, A, Petrova, Guenka, Turcu-Stiolica, Adina, Kawalec, P, Andrzej Pilc, Petrova, Guenka,, Christoph Sowada, Manova, Manoela, Gulbinovic, J, Ewa Stawowczyk, Stawowczyk, Ewa,, Guenka Petrova, Rugaja, Zinta, Draganic, P, Pilc, A, Inotai, Andras,, Kawalec, Paweł,, Stawowczyk, E, Harsanyi, A, Harsanyi, Andras,, Gulbinovič, Jolanta,, Tesar, T, Savova, A, Lenka Vostalova, Tesar, Tomas,, Andras Inotai, Harsanyi, Andras, Pero Draganic, Vostalova, Lenka, Jolanta Gulbinovič, Manova, Manoela,, Andras Harsanyi, Tomas Tesar, Savova, Alexandra, Paweł Kawalec, Petrova, G, Vostalova, Lenka,, Manoela Manova, Draganic, Pero,, Männik, Agnes,, Sowada, Christoph, Alexandra Savova, Inotai, A, Tesar, Tomas, Turcu-Stiolica, A, Savova, Alexandra,, Adina Turcu-Stiolica, Vostalova, L, Männik, Agnes, Gulbinovic, Jolanta   +63 more
core   +1 more source