Log in
RegisterFasting or Fed condition (Canada) [Design Issues]
Dear Mr.ElMag,
The type of studies need to be conducted for Canadian submission will vary depends on the drug molecule you are dealing with.
Category 1. If your drug molecule is a Uncomplicated Immediate Release dosage form;
You need to conduct only fasting study.
However, kindly be informed that if there is a documented serious safety risk to subjects from single-dose administration of the drug or drug product in the absence of food, only fed study is recommended.
Category 2. Complicated Immediate-Release Dosage Forms (narrow therapeutic range drugs, highly toxic drugs and non-linear pharmacokinetics drugs
You need to conduct both fasting and fed studies.
Category 3. Modified Release Drugs
You need to conduct both Fasting and Fed studies
However, be informed that for drugs in category 2 & 3, if there is a documented serious safety risk to subjects from single-dose administration of the drug or drug product in the presence of food or absence of food, only fasting study or only fed study respectively is recommended.
Hence, the study design (Fast and/or Fed study) depends on which category your drug fits into.
The type of studies need to be conducted for Canadian submission will vary depends on the drug molecule you are dealing with.
Category 1. If your drug molecule is a Uncomplicated Immediate Release dosage form;
You need to conduct only fasting study.
However, kindly be informed that if there is a documented serious safety risk to subjects from single-dose administration of the drug or drug product in the absence of food, only fed study is recommended.
Category 2. Complicated Immediate-Release Dosage Forms (narrow therapeutic range drugs, highly toxic drugs and non-linear pharmacokinetics drugs
You need to conduct both fasting and fed studies.
Category 3. Modified Release Drugs
You need to conduct both Fasting and Fed studies
However, be informed that for drugs in category 2 & 3, if there is a documented serious safety risk to subjects from single-dose administration of the drug or drug product in the presence of food or absence of food, only fasting study or only fed study respectively is recommended.
Hence, the study design (Fast and/or Fed study) depends on which category your drug fits into.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Fasting or Fed condition (Canada) ElMag 2012-02-22 16:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fasting or Fed condition (Canada)drgunasakaran1 2012-02-22 16:56
Ing. Helmut Schütz