Bioequivalence and Bioavailability Forum • Any experiences?

Any experiences? [Design Issues]

posted by Helmut – Vienna, Austria, 2014-10-17 21:30 (4273 d 22:56 ago) – Posting: # 13749
Views: 28,439

Ὀδυσσεύς and all,

❝ ❝ As shown in my references the CV_w of PK metrics might be different between genotypes. Do they mean that as well?

❝

❝ In my opinion: YES, see "pharmacokinetics".

OK, I’m convinced.

Pharmacokinetics may be simply
defined as what the body does
to the drug, as opposed to
pharmacodynamics which may be
defined as what the drug does to
the body.*

I never went that route so far (only for safety reasons). Now it gets interesting. Is this an academic issue or do our members have some experiences they could share, like:

Which was the cut-off point (in % of the population? based on the CV?) to specify the most relevant genotype?
Anybody done a study only in a selected genotype showing the lowest variability?
Would you dare to run a study in a ~10% genotype only because the variability is low?
Regulatory acceptance?

Benet LZ
Pharmacokinetics: Basic Principles and Its Use as a Tool in Drug Metabolism
In: Horning MG, Mitchell J (eds) Drug Metabolism and Drug Toxicity
New York, Raven Press (1984) p199
ISBN 0-89004-997-1

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Subject selection ele2008 2014-10-16 05:06
- Genotyping in BE Helmut 2014-10-16 15:04
  - Genotyping in BE ele2008 2014-10-16 16:18
    - Genotyping in BE nobody 2014-10-16 17:43
      - Genotyping in BE Helmut 2014-10-16 18:13
        
        Genotyping in BE nobody 2014-10-16 18:24
        
        Any experiences?Helmut 2014-10-17 19:30
        
        Any experiences? nobody 2014-10-17 20:04
        
        Any experiences? Helmut 2014-10-18 15:04
        
        Any experiences? nobody 2014-10-20 08:06
        
        Any experiences? Helmut 2014-10-20 13:00
        
        Any experiences? nobody 2014-10-20 14:21
- Subject selection ele2008 2014-10-23 05:25
  - Subject selection ele2008 2014-10-23 16:47
    - Subject selection ElMaestro 2014-10-23 17:25
      - Subject selection nobody 2014-10-23 17:53
    - Editing posts Helmut 2014-10-23 17:54
    - ♀ on a mission? Helmut 2014-10-23 19:50