Bioequivalence and Bioavailability Forum • overgeneralization ????

overgeneralization ???? [Regulatives / Guidelines]

posted by luvblooms – India, 2013-02-21 06:23 (4862 d 17:08 ago) – Posting: # 10089
Views: 10,245

Hi Helmut,

❝ Point taken. :no: Terribly sorry.

NO worries!!!

❝ My observations:

❝ • Guidance-bondage intrinsically tied to copy-and-paste-disease.

❝ • Lack of understanding even the most basic principles of GxP, PK, and good biostatistical practice (see the rather incomplete list in the post above).

❝ • Worst: A strong tendency to bend the rules (“make” analytical batches valid, dealing with outliers, etc.).

Totally agree to you on the Copy paste disease and lack of understanding of GxP and PK. Now coming to the rules/guidance (except “make” analytical batches valid, dealing with outliers) aren't they non binding recomendations :cool:

❝ If the FDA requires the median you can’t use the mean without a justification.

Agreed!!!

❝ If you don’t know the cut-off it’s upon the PI’s discretion whether he excludes the subject right away or not. If a subject is already nauseous it may be unethical to continue blood sampling. Furthermore, the subject’s example may influence other volunteers. :vomit:

❝ However, if the PI decides to keep the subject in the study he may be excluded after calculating median t_max,ref of the rest of the group.

We have followed the same in our protocols and till now not received any query on the same (blame it to 30 minute review window)

❝ ❝ Will it be acceptable by EMEA or FDA? (Remember In principle any reason for exclusion is valid provided it is specified in the protocol and the decision to exclude is made before bioanalysis)

❝

❝ That’s a gray area. No experience with the FDA.

FDA prefers the same thing, got some queries on the same and was suggested to do it the EMEA way.

❝ I use the mean instead (although teeth grinding). If we don’t know any value how can we state something in the protocol? See this post on what I use in my protocols. So far I never had a problem (which doesn’t mean a thing).

❝ BTW,Therefore, in the future I expect to see more useful information in PARs.

Agreed.

Now how about ER/MR/XR formulations as per the current guidelines??? 2 times median Tmax or τ (dosing interval)?

—
~A happy Soul~

Complete thread:

FDA dropout guideline for Emesis jag009 2013-02-19 16:16 [Regulatives / Guidelines]
- Median tmax Helmut 2013-02-19 17:49
  - Median tmax jag009 2013-02-19 19:49
    - Median tmax Helmut 2013-02-19 20:28
      - Median tmax jag009 2013-02-19 21:18
        
        Intellectual horsepower Helmut 2013-02-19 21:49
        
        Intellectual horsepower jag009 2013-02-19 22:45
        Intellectual horsepower jag009 2013-02-20 16:12
        
        Intellectual horsepower Helmut 2013-02-20 17:03
        
        Intellectual horsepower jag009 2013-02-20 22:05
      - Median tmax luvblooms 2013-02-20 05:03
        
        Sorry for the overgeneralization Helmut 2013-02-20 16:54
        
        overgeneralization ????luvblooms 2013-02-21 05:23
        
        overgeneralization ???? Helmut 2013-02-21 12:17
        overgeneralization ???? jag009 2013-02-21 16:55
  - Median tmax intuitivepharma 2013-02-28 13:05
    - Median tmax from pilot studies Helmut 2013-02-28 14:02