These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: International Conference on Harmonisation; guidance on Q8(R1) Pharmaceutical Development; addition of annex; availability. Notice.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2009 Jun 09; 74(109):27325-6. PubMed ID: 19588572.
    Abstract:
    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q8(R1) Pharmaceutical Development." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH Q8(R1) guidance includes the previously published parent guidance entitled "Q8 Pharmaceutical Development" (Q8 parent guidance) (71 FR 29344; May 22, 2006) and a newly added annex. The annex provides further clarification of key concepts outlined in the Q8 parent guidance and describes the principles of quality by design (QbD). The annex is intended to show how concepts and tools (e.g., design space) outlined in the Q8 parent guidance could be put into practice by the applicant for all dosage forms.
    [Abstract] [Full Text] [Related] [New Search]