PharmPK Discussion - IVIV Correlation Recommendations

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On 8 Oct 1997 at 11:02:42, Carlos Ramos Mundo (cramos.aaa.cueyatl.uam.mx) sent the message

 Greeting form Mexico!:

 Hello Caro:

I do not if you will use tablet or capsule and there is lack of more info,
but there are several points that we use all the times and they work for
us:

In vitro studies:

1.  Complete dissolution profile. Calculate nonlinear parameters in order
to know complete profile.
2.  Include formulations made by yourself to simulate bad, regular and
good profiles (this take in consideration pharmaceutical aspects).
3. !!! Use experimental designs (factorial or response surface designs),
to assure minimal amount of experiments.
4. Include statistical moments to your responses.

In  vivo studies:

1. If possible, use only male or females.
2. If possible, maintain them under hospital care.
3. !!! Use experimental design !!! (Same reasons).
4. Sample time superior to 8 half life (this take in consideration
pharmacodinamic/pharmacokinetic aspects).
5. If possible, evaluate PK parameters at steady state.
6. If possible, include placebo formulation in one of two optios:
   a. As a previous intake (wash time prior to drug).
   b. Another group of patients with only placebo (if there is any
      noticeble pharmacological effect, it will be under control
      with this group).
7. Even with pH at 7.5 it could be possible to get a IV formula (IM?).

Software:

Personally, I am more comfortable with mathematician software (Matlab,
Mathematica, or so).  Statistical software: SAS or SPSS.

I insist: I will use NONLIN or any PK software only if it is a
requieremente, otherwise the other packages are more friendly and you can
get more flexibility to modelate nonlinear models.

PD: A last sugestion: DO NOT trnasform data to obtain ""Linear"" profiles.
It can produce some lack of info for final models.

I hope these comments are useful.

 !!Good Luck!!

If you need something from this paradise country, let me  know !

*********************************************************************

	Carlos Ramos Mundo, M.S., C.Q.A.

	E mail:   cramos.aaa.cueyatl.uam.mx

	Phone:    (525) 6188739

	Fax:      (525) 7245338

	Address:  Calzada del hueso 1100
	          Mexico, City.
	           MEXICO

******************************************************

modelate

On Tue, 7 Oct 1997, Dr. David Caron wrote:

> pharmpk PK/PD Discussion LISTSERV
> We need to perform a bioequivalence study for a product which is
> insoluble in acid and water, soluble at pH 7.5, highly permeable, with a
> tmax of 3 to 5hours (bioavailability of 95%).
> What would be in terms of in vitro dissolution the parameters to be
> evalauted for a good in vivo in vitro correlation? Which software would
> you recommend to use?
>
> Thank you for your help,
>
> D.Caron, Pharm.D
> CPR
> Israel
> from: "Dr. David Caron" 
> see WWW Server at: http://www.cpb.uokhsc.edu/pkin/pkin.html for more info
>

from: Carlos Ramos Mundo

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