The wider use of fixed-dose combinations emphasizes the need for a global approach to regulatory guideline development
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
The wider use of fixed-dose combinations emphasizes the need for a global approach to regulatory guideline development. / Gautam, Yvonne; Bjerrum, Ole Jannik; Schmiegelow, Merete.
I: Therapeutic Innovation & Regulatory Science, Bind 49, Nr. 1, 2015, s. 197-204.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - The wider use of fixed-dose combinations emphasizes the need for a global approach to regulatory guideline development
AU - Gautam, Yvonne
AU - Bjerrum, Ole Jannik
AU - Schmiegelow, Merete
PY - 2015
Y1 - 2015
N2 - A fixed-dose combination (FDC) is a drug product in which two or more separate drug components (active pharmaceuticalingredients) are combined in a single-dosage form. Interest in developing FDCs is increasing in a range of diseases. This projectinvestigated the regulatory environment for FDCs in the EU and US. A review of the FDC guidelines set forth by the EMA, FDA,and ICH, followed by interviews of key informants in industry, identified 5 main industry concerns related to development ofFDCs. These concerns were presented to key informants from both the EU and US regulatory authorities. It was clear from theresults that the current regulatory environment for FDCs lacks consistency. This may create a barrier to innovation movingfrom the laboratory to the clinic, as companies cannot clearly see the development path requirements. This project also highlightedcertain challenges that currently face the regulatory world: how to improve the role of regulatory science and provideclear quantification in assessment decisions; the role of guidelines and their impact on innovation; and, most important, thequestion of globalization and how to move toward a more harmonized regulatory system.
AB - A fixed-dose combination (FDC) is a drug product in which two or more separate drug components (active pharmaceuticalingredients) are combined in a single-dosage form. Interest in developing FDCs is increasing in a range of diseases. This projectinvestigated the regulatory environment for FDCs in the EU and US. A review of the FDC guidelines set forth by the EMA, FDA,and ICH, followed by interviews of key informants in industry, identified 5 main industry concerns related to development ofFDCs. These concerns were presented to key informants from both the EU and US regulatory authorities. It was clear from theresults that the current regulatory environment for FDCs lacks consistency. This may create a barrier to innovation movingfrom the laboratory to the clinic, as companies cannot clearly see the development path requirements. This project also highlightedcertain challenges that currently face the regulatory world: how to improve the role of regulatory science and provideclear quantification in assessment decisions; the role of guidelines and their impact on innovation; and, most important, thequestion of globalization and how to move toward a more harmonized regulatory system.
KW - Faculty of Health and Medical Sciences
KW - fixed-dose combination
KW - guidelines
KW - drug combinations
KW - medicines
KW - deveopment
KW - innovation
KW - regulatory science
KW - global
U2 - 10.1177/2168479014543699
DO - 10.1177/2168479014543699
M3 - Journal article
VL - 49
SP - 197
EP - 204
JO - Therapeutic Innovation & Regulatory Science
JF - Therapeutic Innovation & Regulatory Science
SN - 2168-4790
IS - 1
ER -
ID: 120900448