Changing innovation into a registered product: From concept to regulatory approval.
Theriogenology
; 112: 75-81, 2018 May.
Article
in En
| MEDLINE
| ID: mdl-28716338
ABSTRACT
Innovation in animal health pharmaceuticals is important to address unmet and underserved medical needs, and often comes from products initially developed for human medicine. The purpose of the review is to help readers understand how breakthroughs from human biotechnology may be developed for use in veterinary medicine, while understanding the key drivers to success, the difficulties of regulatory approval, and the realistic risks and rewards of developing applications for animals. The types of human drugs which may be useful for veterinary applications are reviewed, including examples. The regulatory path is discussed, with a review of the various oversight agencies, and the categories of data required to be submitted, including safety, efficacy, manufacturing, environmental impact and human food safety. In conclusion, the cost, development time, and barriers to innovation in veterinary medical pharmaceuticals are discussed.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Technology, Pharmaceutical
/
Veterinary Drugs
/
Legislation, Drug
Type of study:
Prognostic_studies
Limits:
Animals
/
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Theriogenology
Year:
2018
Document type:
Article