Helmut
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Vienna, Austria,
2010-12-14 13:33
(4852 d 19:43 ago)

Posting: # 6300
Views: 4,700
 

 Scaling (EU) [Surveys]

Dear all,

have you performed a BE-study with scaling for Cmax already?

If yes, which statistical code have you used?
  1. FDA's (2001) for IBE/PBE to calculate sigmaWR; ABEL according to EMA (2010).
  2. FDA's (2010) => ABEL.
  3. Other (= what a question; I always write my own stuff!)
If no, why not?
  1. I'm still confused and waiting until my CRO(s) get a better understanding.
  2. I'm waiting for EMA's code.
  3. I want to avoid discussions and stick to 80%-125%.
  4. What the h... are you talking about?

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d_labes
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Berlin, Germany,
2010-12-14 13:56
(4852 d 19:20 ago)

@ Helmut
Posting: # 6301
Views: 3,785
 

 Scaling (EU)

Dear Helmut!

Yes.
1. but ABE code with Proc MIXED to get sigmaWR, Appendix E
(I suppose You meant that and not IBE/PBE Appendix F/G)
as well as 2.

But also named under no:

❝ 2. I'm waiting for EMA's code !


Regards,

Detlew
Helmut
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Vienna, Austria,
2010-12-14 14:01
(4852 d 19:15 ago)

@ d_labes
Posting: # 6302
Views: 3,802
 

 Scaling (EU)

Dear D. Labes!

❝ (I suppose You meant [...] not IBE/PBE Appendix F/G)


Oops, sure.

BTW, myself: yes (1) and no (2).

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