Draft guidance document on comparative pharmacokinetic studies for orally inhaled products: Closed consultation
From Health Canada
Current status: Closed
This consultation ran from February 26, 2020, to May 26, 2020.
This guidance document provides sponsors of new drug submissions and abbreviated new drug submissions with the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations. The information is related to comparative pharmacokinetic studies, with emphasis on in vivo comparative pharmacokinetic studies, used to support the safety and efficacy of subsequent-entry orally inhaled drug products (OIP).
Who was the focus of this consultation
We engaged with:
- members of the pharmaceutical industry
- health professionals
Goals of the consultation
The goal of this consultation was to receive feedback on the guidance document on comparative pharmacokinetic studies for orally inhaled products. This guidance document informs stakeholders on the submission requirements for orally inhaled products. It also provides more clarity, consistency, transparency and predictability for manufacturers in filing drug submissions.
Key questions for discussion
We sought comments or concerns from stakeholders regarding the guidance document on comparative pharmacokinetic studies for orally inhaled products.
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa ON K1A 0K9
Fax: (613) 941-1812
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