kishorpatil
☆    

2011-02-08 11:24
(5118 d 13:35 ago)

Posting: # 6582
Views: 6,876
 

 Therapeutic equivalence [Design Issues]

Dear All,

Can any body tell me it is possible to conduct therapeutics equivalence/BE study of one oncology products/Anticancer drug in healthy volunteer. If any guideline for that please provide the link for the same.

Regards
PK


Edit: Category changed. I deleted another post with the same wording. [Helmut]
d_labes
★★★

Berlin, Germany,
2011-02-08 11:37
(5118 d 13:22 ago)

@ kishorpatil
Posting: # 6584
Views: 5,898
 

 Therapeutic equivalence?

Dear PK,

what therapeutic action of an Anti-cancer agent do you expect in healthy volunteers :ponder:?

Due to the cytotoxic effects of most Anti-cancer agents it's IMHO unethically to treat healthy volunteers with them. So also a classical BE study (comparing blood/plasma/serum levels is IMHO also not possible in most cases :no:.

Regards,

Detlew
Dr_Dan
★★  

Germany,
2011-02-08 15:40
(5118 d 09:20 ago)

@ d_labes
Posting: # 6593
Views: 5,925
 

 Therapeutic equivalence?

Dear d_labes
not all anti-cancer drugs are cytotoxic, for example aromatase inhibitors for treating breast cancer or imatinib, a phenylaminopyrimidine derivative, which is a selective inhibitor of the tyrosine kinase activity of BCR-ABL fusion gene (oncoprotein), the product of the Philadelphia chromosome. You can test these drugs in healthy subjects, no problem. Other drugs like capecitabine or temozolomide can only be tested in patients. So it depends.
Dan

Kind regards and have a nice day
Dr_Dan
d_labes
★★★

Berlin, Germany,
2011-02-08 15:45
(5118 d 09:14 ago)

@ Dr_Dan
Posting: # 6594
Views: 5,906
 

 Therapeutic equivalence?

Dear Dan,

❝ So it depends.


As always in real life ;-).
Thanks for enlighten me.

Regards,

Detlew
bjkim97
☆    

Korea / Seoul,
2011-02-23 12:06
(5103 d 12:53 ago)

@ Dr_Dan
Posting: # 6663
Views: 5,754
 

 Therapeutic equivalence?

Dear Dan

I understand your opinion. Anti-Cancer is not all cytotoxic. I agree with your opinion

You say about the imatinib that "No problem"
Then if so, did you think the tests are performed.

Please tell me studying about the imatinib of healthy volunteer.
Safety, AE (adverse event), specific issue eg.

Your advice is very helpful to me!

Kind regard
BJ
Dr_Dan
★★  

Germany,
2011-02-28 15:53
(5098 d 09:06 ago)

@ bjkim97
Posting: # 6672
Views: 5,804
 

 Therapeutic equivalence?

Dear BJ
I performed several BE studies with imatinib to evaluate and compare the relative bioavailability and therefore the bioequivalence of two different formulations of imatinib after a single oral dose administration under fed conditions, since imatinib should be administered orally with a meal and a glass of water to minimize the risk of gastrointestinal irritations as per label. These were very easy studies since the intra-subject variability of the drug is low and the tolerability is excellent.
Don't worry, it is just an ordinary BE study, no additional safety examinations needed.
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan
bjkim97
☆    

Korea / Seoul,
2011-03-03 13:37
(5095 d 11:22 ago)

@ Dr_Dan
Posting: # 6693
Views: 5,705
 

 Therapeutic equivalence?

Thank you for reply MR Dan

But no one expected the authorities of your country permit did not have?
As you know yourself, FDA recommend that patients with Imatinib to look at is.
Not available as well as healthy adults, but not the PK DATA, Issue, did not we.

Yet I did not proceed too many questions to be asked.
We look forward to in kind. ^_^;;

Thank you so much Dan
BJ


Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Mauricio Sampaio
★    

Brazil,
2024-06-17 04:21
(240 d 21:38 ago)

@ d_labes
Posting: # 24030
Views: 1,685
 

 Therapeutic equivalence?

Cytotoxic effects in a single dose??? You must be joking.
raghu
★    

India,
2011-02-09 11:07
(5117 d 13:52 ago)

@ kishorpatil
Posting: # 6600
Views: 6,053
 

 Therapeutic equivalence

Dear Mr Kishore,

You can conduct BE study in healthy volunteers if the anticancer drug not shows any cytotoxic or any major health risk for participating healthy subjects.

Therapeutic equivalence study should be conducted in patients.

Regards
Raghu.
UA Flag
Activity
 Admin contact
23,380 posts in 4,914 threads, 1,661 registered users;
42 visitors (0 registered, 42 guests [including 2 identified bots]).
Forum time: 01:00 CET (Europe/Vienna)

Everything is trivial, if you know the answer.    Thomas Jaki

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5