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RegisterHealthy volunteers vs. patients [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2011-06-24 17:40 (5483 d 22:06 ago) – Posting: # 7171
Views: 6,668
Dear Marcel!
I’m not sure what you mean by ‘…before moving to patients’. While in the draft GL EMA suggested to assess BE in the highest dose stated in the innovator’s SmPC, the current GL (Section 4.1.6) recommends (if linear PK applies) the highest strength. For highly soluble drugs a lower strength is also acceptable. For non-linear PK, it depends on the type of non-linearity; see the respective section.
Essentially two points:
❝ When choosing a dose for the conduct of a bioequivalence study, is it your understanding that one should move from highest dose to lowest dose (or highest tolerable dose) in healthy subjects before moving to patients?
I’m not sure what you mean by ‘…before moving to patients’. While in the draft GL EMA suggested to assess BE in the highest dose stated in the innovator’s SmPC, the current GL (Section 4.1.6) recommends (if linear PK applies) the highest strength. For highly soluble drugs a lower strength is also acceptable. For non-linear PK, it depends on the type of non-linearity; see the respective section.
❝ As well, can you expand on your statement that healthy volunteers allow for better standardization?
Essentially two points:
- Logistics: It’s much easier to find healthy volunteers complying with tight inclusion criteria (e.g., BMI-range, no co-medication, …) than patients.
- Variability: Expected to be higher in patients due to their disease state.
—
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Assay percentage, Healthy volunteer, PI raghavendra_s 2010-11-25 04:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Assay percentage, Healthy volunteer, PI manan 2010-11-25 10:43
- Assay percentage, healthy volunteers Helmut 2010-11-25 15:44
- Potency correction? It depends d_labes 2010-11-26 10:38
- THX! Helmut 2010-11-26 14:18
- Assay percentage, healthy volunteers Marcel 2011-06-24 15:19
- Healthy volunteers vs. patientsHelmut 2011-06-24 15:40
- Healthy volunteers vs. patients Marcel 2011-06-24 16:03
- Healthy volunteers vs. patientsHelmut 2011-06-24 15:40
- Potency correction? It depends d_labes 2010-11-26 10:38
Ing. Helmut Schütz