PharmPK Discussion - Dissolution profile comparison

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On 26 Mar 2004 at 19:39:26, "Carlos Montuenga Barreira" (cmrbarreira.-at-.hotmail.com) sent the message


  Dear collegues
Does someone know if there are commercial statistical programmes
available for similarity demostration between dissolution profiles,
when the f2 proof is not suitable because of high variability of
dissolution means?
Thank you and kinds regards

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On 26 Mar 2004 at 21:50:48, "kiran shankar lagu" (kiranlagu.aaa.rediffmail.com) sent the message

Do you intend to widen the criteria for similarity demonstration if f2
criteria is not suitable? What if the bio is ok?
Regards
Kiran

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On 27 Mar 2004 at 11:16:35, "Durisova Maria" (exfamadu.-a-.savba.sk) sent the message


Dear Carlos,
Such a program was employed in  the article:
  Ded\0xCCk, L. M. Durisov\0xB7: System-approach methods for modeling
and testing similarity of in vitro dissolutions of  drug dosage
formulations.
Comput. Methods Programs Biomed. 2002, 69; 49-55.
  http://www.sciencedirect.com/
  The program  is commercially available:
dedik.-a-.kam.vm.stuba.sk
  Sincerely,
Maria Durisova, PhD, DSc (Math/Phys)
Vice Director
and
Head of Department of Pharmacokinetics
Institute of Experimental Pharmacology
Slovak Academy of Sciences
D\0x02D9bravska cesta 9
841 04 Bratislava
Slovak Republic
Tel./Fax: +421 2 54775928
http://www.uef.sav.sk/durisova.htm

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On 27 Aug 2004 at 12:19:46, "Vishal P. Borikar" (vishalb.-a-.glenmarkpharma.com) sent the message


      dear sir
                what is the F2 value in dissolution profile and is their
any specific criteria for dissolution while conducting the
bioequivalence study

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On 27 Aug 2004 at 10:19:52, "Sunil Vandse" (SVandse.aaa.ablelabs.com) sent the message


Dear Vishal,
I am not really sure I understand your question correctly. F2 is used
to compare dissolution profile of two formulations. If you have a
product with multiple strenths and you do the BE on highest or lowest
strength against a reference product, then you use F2 (or F1/ any other
statistical methods) to demonstrate that all other strengths of your
product have similar dissolution profile as that of BE lot and
therefore qualify for bio-waiver (i.e assuming all strengths are dose
proportional/look alike). F2 is also used to demonstrate similarity in
case of SUPAC.
Hope this helps,
Sunil Vandse

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On 27 Aug 2004 at 20:25:25, =?ISO-8859-1?Q? "Helmut_Schutz" ?= (helmut.schuetz.at.bebac.at) sent the message


Dear Vishal,
(hopefully) you will find the following references useful.
FDA (USA)
http://www.fda.gov/cder/guidance/5356fnl.pdf
http://www.fda.gov/cder/guidance/3618fnl.pdf
http://www.fda.gov/cder/guidance/1713bp1.pdf
http://www.fda.gov/cder/guidance/1214fnl.pdf
EMEA (EU):
http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf
Regards,
Helmut
--
Helmut Schutz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
A-1070 Vienna/Austria
tel/fax +43 1 9713935
http://BEBAC.at http://forum.bebac.at
http://www.goldmark.org/netrants/no-word/attach.html

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