AIMC Topic: Drugs, Generic

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Machine learning driven bioequivalence risk assessment at an early stage of generic drug development.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V Oct 26, 2024
BACKGROUND: Bioequivalence risk assessment as an extension of quality risk management lacks examples of quantitative approaches to risk assessment at an early stage of generic drug development. The aim of our study was to develop a model-based approa...
Drug Development Bayes Theorem Machine Learning Risk Assessment Therapeutic Equivalency Drugs, Generic Solubility Biological Availability Humans
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Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop.

The AAPS journal Apr 8, 2024
The 2023 Generic Drug Science and Research Initiative Public Workshop organized by the U.S. Food and Drug Administration (FDA) discussed the research needs to improve and enhance bioequivalence (BE) approaches for generic drug development. FDA takes ...
United States Food and Drug Administration Therapeutic Equivalency Drugs, Generic United States Drug Development Artificial Intelligence
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NEAL: an open-source tool for audio annotation.

PeerJ Aug 25, 2023
Passive acoustic monitoring is used widely in ecology, biodiversity, and conservation studies. Data sets collected via acoustic monitoring are often extremely large and built to be processed automatically using artificial intelligence and machine lea...
Artificial Intelligence Algorithms Drugs, Generic Biodiversity Acoustics
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Artificial intelligence-enhanced care pathway planning and scheduling system: content validity assessment of required functionalities.

BMC health services research Dec 12, 2022
BACKGROUND: Artificial intelligence (AI) and machine learning are transforming the optimization of clinical and patient workflows in healthcare. There is a need for research to specify clinical requirements for AI-enhanced care pathway planning and s...
Critical Pathways Drugs, Generic Artificial Intelligence Machine Learning Prospective Studies Health Facilities Humans
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Improving Global Healthcare and Reducing Costs Using Second-Generation Artificial Intelligence-Based Digital Pills: A Market Disruptor.

International journal of environmental research and public health Jan 19, 2021
Improving global health requires making current and future drugs more effective and affordable. While healthcare systems around the world are faced with increasing costs, branded and generic drug companies are facing the challenge of creating market...
Drugs, Generic Health Care Costs Delivery of Health Care Humans Telemedicine Health Facilities Artificial Intelligence Quality of Health Care
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Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.

Clinical pharmacology and therapeutics Jun 12, 2019
Generic drug products are approved by the US Food and Drug Administration (FDA) through Abbreviated New Drug Applications (ANDAs). The ANDA review and approval involves multiple offices across the FDA. Forecasting ANDA submissions can critically info...
Time Factors United States United States Food and Drug Administration Drug Approval Humans Machine Learning Drugs, Generic Resource Allocation
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Natural language processing-based assessment of consistency in summaries of product characteristics of generic antimicrobials.

Pharmacology research & perspectives Nov 11, 2018
To investigate consistency in summaries of product characteristics (SmPCs) of generic antimicrobials, we used natural language processing (NLP) to analyze and compare large amounts of text quantifying consistency between original and generic SmPCs. W...
Anti-Infective Agents United Kingdom Drugs, Generic Drug Labeling Natural Language Processing Guidelines as Topic
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Automating the Identification of Safety Events Involving Machine Learning-Enabled Medical Devices.

Studies in health technology and informatics Jan 25, 2024
With growing use of machine learning (ML)-enabled medical devices by clinicians and consumers safety events involving these systems are emerging. Current analysis of safety events heavily relies on retrospective review by experts, which is time consu...
Machine Learning Drugs, Generic
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Searches for randomized controlled trials of drugs in MEDLINE and EMBASE using only generic drug names compared with searches applied in current practice in systematic reviews.

Research synthesis methods Jun 1, 2015
BACKGROUND: It is unclear which terms should be included in bibliographic searches for randomized controlled trials (RCTs) of drugs, and identifying relevant drug terms can be extremely laborious. The aim of our analysis was to determine whether a bi...
Drugs, Generic Data Mining Drug Labeling Natural Language Processing Vocabulary, Controlled MEDLINE Drug Evaluation Review Literature as Topic Databases, Bibliographic Randomized Controlled Trials as Topic
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