drug development process

drug development process

A generic term for the mechanisms by which an investigational product advances from preclinical studies to clinical trials, through to approval for marketing after review by regulatory agencies.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
References in periodicals archive ?
He was most recently senior medical director at Janssen Biopharma, where he led the early drug development process of an HBV capsid assembly modulator from late pre-clinical development into Phase 2a drug development.
Substances that are harmful to embryos will thus be detected early in the drug development process and not only in embryotoxicity studies in animal trials.
Orphan Drug designation includes 7-year market exclusivity following marketing approval, FDA assistance during the drug development process, and exemption of application fees.
"There is a need in the drug development process to have better models to predict responses of the human body and to gauge toxicity much earlier in the process, as well as to check that a potential drug actually does what it's supposed to without adverse side effects," commented Lucie Low in a NASA press release from late 2018.
Alvero, one of the presenters at the National Research and Development Conference 2019 held by the Department of Science and Technology last Wednesday at the Philippine International Convention Center (PICC) in Pasay City, said that they were determined to pursue the full drug development process to make the breakthrough drug to help cure and stop deaths from dengue.
By working with AstraZeneca, we can explore the potential of these new modalities in the early-stage drug development process. Regina Fritsche Danielson, Vice President and Head of CVRM, IMED Biotech Unit, AstraZeneca, said Targeted kidney delivery of oligonucleotides has remained a challenging task for several years.
Mirataz was brought to market for under $5 million and in less than five years, validating KindredBio's rapid and efficient drug development process, the publication said.
"As we continue to accelerate the creation of transformative medicines, we are pursuing strategic collaborations that enable researchers to move quickly in the drug development process. We are very pleased to announce our collaboration with Ajinomoto Bio-Pharma Services as it exemplifies our goal to provide the Nano-Assemblr platform for the seamless scale up from discovery to GMP manufacturing of the next generation nanomedicines" said James Taylor, co-founder and chief executive officer for PNI.
"AI has the potential to transform the drug development process by making it both more efficient and effective, thus benefiting all parties involved—from the companies developing new drugs to the patients in desperate need of viable treatments," says Wright.
"One occurs at the front end of the drug development process, when generic drugs are being developed.
It also enables us to collaborate with some of the world's brightest medicinal chemists and biologists to optimize the drug development process.'
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