Results 1 to 10 of about 4,484,991 (333)

Predictive Analysis for First Submission of Generic Drug Application for Orphan Drug Products Using Random Survival Forest [PDF]

Clinical and Translational Science
Rare diseases affect a small population of patients, resulting in low incentives for developing orphan drug products (ODPs). The United States Congress passed the Orphan Drug Act of 1983 to incentivize pharmaceutical manufacturers to develop drugs to ...
Robert Hopefl, Jing Wang, Abhinav Ram Mohan, Wei‐Jhe Sun, Myong‐Jin Kim, Meng Hu, Lanyan Fang   +6 more
doaj   +2 more sources

Drug Repurposing of Generic Drugs: Challenges and the Potential Role for Government

Applied Health Economics and Health Policy, 2023
Drug repurposing is the process of identifying a new use for an existing drug or active substance in an indication outside the scope of the original indication.
K. H. van der Pol, M. Aljofan, Olivier Blin, J. Cornel, G. Rongen, Aurélie-Gaëlle Woestelandt, M. Spedding   +6 more
semanticscholar   +1 more source

Knowledge, perception and acceptance of generic drugs in the general Lebanese population: A cross-sectional survey among adults

The Journal of Medicine Access, 2023
Background: Many governments encouraged generic use to enhance health equality and minimise health expenditure. The lack of knowledge and acceptance of generic medicines are the main barriers to their use.
Georges Hatem, Rana Itani, Roula Ajrouche, Nour Abbas, Rita Farah, Mathijs Goossens, S. Awada   +6 more
semanticscholar   +1 more source

Impact of ‘4+7’ volume-based drug procurement on the use of policy-related original and generic drugs: a natural experimental study in China

BMJ Open, 2022
Objective To evaluate the impact of the first round of the National Centralized Drug Procurement pilot (so-called ‘4+7’ policy) on the use of policy-related original and generic drugs. Methods A retrospective natural experimental design was adopted. Drug
Jing Wang, Ying Yang, Luxinyi Xu, Yuan Shen, Xiaotong Wen, Lining Mao, Quan Wang, D. Cui, Z. Mao   +8 more
semanticscholar   +1 more source

Bioequivalence, Drugs with Narrow Therapeutic Index and the Phenomenon of Biocreep: A Critical Analysis of the System for Generic Substitution

Healthcare, 2022
The prescription of generic drugs represents one of the main cost-containment strategies of health systems, aimed at reducing pharmaceutical expenditure.
L. Gozzo, F. Caraci, F. Drago
semanticscholar   +1 more source

The Evolution of Supply and Demand in Markets for Generic Drugs.

Milbank Quarterly, 2021
Policy Points Much concern about generic drug markets has emerged in recent policy debates. Important changes in regulations, the structure of purchasing, and the length of the drug supply chain have affected generic drug markets.
R. Frank, T. Mcguire, Ian Nason
semanticscholar   +1 more source

Quantitative methods and modeling to assess COVID‐19‐interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches

CPT: Pharmacometrics & Systems Pharmacology, 2022
The coronavirus disease 2019 (COVID‐19) has presented unprecedented challenges to the generic drug development, including interruptions in bioequivalence (BE) studies.
Yuqing Gong, Kairui Feng, Peijue Zhang, Jieon Lee, Yuzhuo Pan, Zhen Zhang, Zhanglin Ni, Tao Bai, Miyoung Yoon, Bing Li, Carol Y. Kim, Lanyan Fang, Liang Zhao   +12 more
doaj   +1 more source

Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users

Clinical and Translational Science, 2021
This study assessed the impact of product particle sizes (fine: 106–500 µm; coarse: 500–1000 µm) on oxycodone pharmacokinetics (PK) following nasal insufflation of milled oxycodone extended‐release (ER) abuse‐deterrent (AD) tablets using immediate ...
Saeid Raofi, Minori Kinjo, Dajun Sun, Zhichuan Li, Heather Boyce, Karthika Natarajan, Mitchell Frost, Liang Zhao, Markham Luke, Robert Lionberger, Debra Kelsh, Myong‐Jin Kim   +11 more
doaj   +1 more source

Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development

Pharmaceutics, 2022
Dry powder inhalers (DPIs) are drug–device combination products where the complexity of the formulation, its interaction with the device, and input from users play important roles in the drug delivery.
Abhinav Ram Mohan, Qiang Wang, Sneha Dhapare, Elizabeth Bielski, Anubhav Kaviratna, Liangfeng Han, Susan Boc, Bryan Newman   +7 more
doaj   +1 more source

Heterogeneous treatment effect analysis based on machine‐learning methodology

CPT: Pharmacometrics & Systems Pharmacology, 2021
Heterogeneous treatment effect (HTE) analysis focuses on examining varying treatment effects for individuals or subgroups in a population. For example, an HTE‐informed understanding can critically guide physicians to individualize the medical treatment ...
Xiajing Gong, Meng Hu, Mahashweta Basu, Liang Zhao   +3 more
doaj   +1 more source