AI Medical Compendium Topic

Explore the latest research on artificial intelligence and machine learning in medicine.

Drug Approval

Showing 11 to 20 of 20 articles

Clear Filters

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.

Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs
Future development of innovative artificial organs is closely related with cutting edge emerging technology. These technologies include brain machine or computer interface, organs made by three dimensional bioprinting, organs designed from induced-pl...

Comparing Machine Learning Algorithms for Predicting Drug-Induced Liver Injury (DILI).

Molecular pharmaceutics
Drug-induced liver injury (DILI) is one the most unpredictable adverse reactions to xenobiotics in humans and the leading cause of postmarketing withdrawals of approved drugs. To date, these drugs have been collated by the FDA to form the DILIRank da...

Machine Learning in Drug Discovery and Development Part 1: A Primer.

CPT: pharmacometrics & systems pharmacology
Artificial intelligence, in particular machine learning (ML), has emerged as a key promising pillar to overcome the high failure rate in drug development. Here, we present a primer on the ML algorithms most commonly used in drug discovery and develop...

On strategic choices faced by large pharmaceutical laboratories and their effect on innovation risk under fuzzy conditions.

Artificial intelligence in medicine
OBJECTIVES: We develop a fuzzy evaluation model that provides managers at different responsibility levels in pharmaceutical laboratories with a rich picture of their innovation risk as well as that of competitors. This would help them take better str...

Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2.

JCO clinical cancer informatics
PURPOSE: Drug development in oncology currently is facing a conjunction of an increasing number of antineoplastic agents (ANAs) candidate for phase I clinical trials (P1CTs) and an important attrition rate for final approval. We aimed to develop a ma...

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.

Clinical pharmacology and therapeutics
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...

SuperDRUG2: a one stop resource for approved/marketed drugs.

Nucleic acids research
Regular monitoring of drug regulatory agency web sites and similar resources for information on new drug approvals and changes to legal status of marketed drugs is impractical. It requires navigation through several resources to find complete informa...

A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

Clinical pharmacology and therapeutics
We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology dr...