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Hi all,
Can some one help me regarding the BE studies requirements in Canada?
1. From where can I get the Reference listed drug details?
2. Does the Canadian agency accept BE studies data for he product
compared with RLD of the same company but marketed in someother country
( say US)
3. If the innovator is selling the drug product world wide, how can
we come to know that the manufacturing process is the same for
product marketed in different countries?
Thanks in adv..
Vardhini
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The following message was posted to: PharmPK
Vardhini:
The following link should help you out with most of your questions.
http://www.hc-sc.gc.ca/english/about/about.html
Good Luck,
Prasad
Prasad NV Tata, M.Pharm., Ph.D.
Manager-Pharmacokinetics
Mallinckrodt, Inc.
675 McDonnell Blvd.
Saint Louis, MO 63134-5840
Tel: (314) 654-5325
Fax: (314) 654-9325
e-mail: prasad.tata.-a-.tycohealthcare.com
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Hi Vardhini,
Health Canada's (HC) Therapeutic Products Directorate's (TPD) BE
requirements are similar (assuming the "average bioequivalence"
approach) to those of the US FDA, especially for immediate release
formulations, except that for Cmax only the Test/Ref ratio must be
within 80-125% based on natural log transformation of the data. (i.e.
In Canada no 90% Confidence Interval for Cmax is required.)
As an aside, the current requirement internationally (FDA, CPMP and HC)
of requiring log transformation of AUC and Cmax and an 80-125% C.I. has
long been the standard in Canada. Also, HC never promulgated the
"Individual Bioequivalence" approach which the FDA appeared to be on
the verge of adopting (especially for "highly variable" drugs) a couple
years ago.
Concerning, the reference formulation, this must be a product that is
actually on the market in Canada.
I'd suggest that you check the TPD website for additional details
especially re. those relating to manufacturing. The TPD ULR
is:http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/
index_drugs_information_guidelines_e.html
Best regards,
Peter
Peter W. Mullen, PhD, FCSFS
KEMIC BIORESEARCH
Kentville
Nova Scotia, B4N 4H8
Canada
Tel.: 902-678-8195 Fax: 902-678-2839 Email:pmullen.-a-.kemic.com
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The following message was posted to: PharmPK
Dear Vardhini,
You have to prove bioequivalence against the RLD and Reference listed
drug for canadian generics can be easily located on Drug Product
Database (DPD) on http://www.hc-sc.gc.ca website.You just cannot take
the RLD from any other markets (like US) if your intent is to develop
the generic equivalent for Candian market.
Regards,
Pradeep
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Hi,
Thanks for your valuable reply.
When we check for RLD in Orange book. We find the RLD status. it says
either yes or no. But I am not able to find any such reference in DPD.
Can you kindly enlighten me on this,
Thanks once again.
Vardhini
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The following message was posted to: PharmPK
Health Canada ,however ,doesnot specify the Canadian Reference Product
like USFDA provides in Orange Book in my knowledge. But for more
information its worth considering the following canadian guidances for
selection of Candian Reference Product in BE/BA studies.
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/bio-a_e.html
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/canrefer_e.html
Kind Regards,
Pradeep Bhadauria
RANBAXY RESEARCH LABORATORIES.
INDIA.
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Dear Vardhini,
There is no Canadian equivalent to the Orange book.
Generally the BE study should be performed with the highest strength of
marketed drug-product unless safety of the subjects is at risk. Then a
waiver for BE study on the lower strength drug-product is requested.
This apply only if the dosage forms are proportional in their ratio of
the active ingredients to the excipients.
Exception from this rule is the case of compounds known to exhibit
nonlinear pharmacokinetics.
radu
Radu D. Pop
Director Biopharmaceutics
Pharma Medica Research Inc.
966 Pantera Drive
Mississauga, Ontario
Canada, L4W 2S1
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