pravin17
★    

India,
2016-05-03 10:07
(2886 d 14:29 ago)

Posting: # 16263
Views: 9,140
 

 Reg-Bio Availability or Bio Equivalence study [Design Issues]

Dear All,

Test product is extended release tablet compered with reference product which is immediate release tablet, my question is whether this study is bio availability study or bio equivalence study?

Thank You in Advance

Pravin


Edit: Category changed; see also this post #1. [Helmut]
Ohlbe
★★★

France,
2016-05-03 12:25
(2886 d 12:11 ago)

@ pravin17
Posting: # 16264
Views: 7,985
 

 Bio Availability or Bio Equivalence study

Dear Pravin,

What is your opinion ?

Do you think an extended release formulation can be bioequivalent to an immediate release fomulation ?

Regards
Ohlbe
jag009
★★★

NJ,
2016-05-10 01:09
(2879 d 23:27 ago)

@ Ohlbe
Posting: # 16285
Views: 7,640
 

 Bio Availability or Bio Equivalence study

Hi Ohlbe

❝ Do you think an extended release formulation can be bioequivalent to an immediate release fomulation ?


It is possible if he is talking about a ER q.d. vs IR b.i.d (or t.i.d, or q.i.d.) formulation under the same total daily dose where in some cases one might want to demonstrate bioquivalence between the two products. Example, Ultram ER is bioequivalent to Tramadol IR (given as qid)....

John
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2016-05-10 18:08
(2879 d 06:28 ago)

@ jag009
Posting: # 16287
Views: 7,639
 

 Different rates = BE if intentional (FDA def.)

Hi John & Ohlbe,

❝ It is possible if he is talking about a ER q.d. vs IR b.i.d (or t.i.d, or q.i.d.) formulation under the same total daily dose where in some cases one might want to demonstrate bioquivalence between the two products. Example, Ultram ER is bioequivalent to Tramadol IR (given as qid)....


[image]

CFR 21(5) §320.1

(a) Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.

Already this definition sends pharmacokineticists through the ceiling. According to the book, BA means only the AUC (strictly speaking the AUC0–∞ or AUC0–τ). There is no “rate of BA” in PK. ;-)

(e) Bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Where there is an intentional difference in rate (e.g., in certain extended release dosage forms), certain pharmaceutical equivalents or alternatives may be considered bioequivalent if there is no significant difference in the extent to which the active ingredient or moiety from each product becomes available at the site of drug action. This applies only if the difference in the rate at which the active ingredient or moiety becomes available at the site of drug action is intentional and is reflected in the proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug.

So, given the blue part, John is right.

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Ohlbe
★★★

France,
2016-05-11 00:03
(2879 d 00:33 ago)

@ Helmut
Posting: # 16289
Views: 7,517
 

 Different rates = BE if intentional (FDA def.)

Dear Helmut and John,

❝ So, given the blue part, John is right.


On a purely US, regulatory, non-PK point of view, yes ;-)

Regards
Ohlbe
nobody
nothing

2016-05-03 12:41
(2886 d 11:55 ago)

@ pravin17
Posting: # 16265
Views: 8,008
 

 Bio Availability or Bio Equivalence study

Hi Pravin!

...if you try the latter and nobody in your organization stops you, at least the ethics board should have substantial objections ;-)

Kindest regards, nobody
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2016-05-03 13:55
(2886 d 10:41 ago)

@ pravin17
Posting: # 16267
Views: 8,161
 

 Bioequivalence study?

Hi Pravin,

I know one European assessor who rejects protocols containing the word bioequivalence in its title. Yes, even if it is a study of IR vs. IR.

Homework: Why does he do so?
Bonus question: Why is he right?

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nobody
nothing

2016-05-03 16:07
(2886 d 08:29 ago)

@ Helmut
Posting: # 16269
Views: 8,035
 

 Bioequivalence study?

❝ I know one European assessor who rejects protocols containing the word bioequivalence in its title. Yes, even if it is a study of IR vs. IR.


Guy with "comparative bioavailability" hobby? :-D

Kindest regards, nobody
d_labes
★★★

Berlin, Germany,
2016-05-03 17:50
(2886 d 06:46 ago)

@ Helmut
Posting: # 16272
Views: 7,978
 

 Bioequivalence study

Hi Helmut,

❝ I know one European assessor who rejects protocols containing the word bioequivalence in its title. Yes, even if it is a study of IR vs. IR.


❝ Homework: Why does he do so?


To be not bounded by an document called "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" in his assessment? :-D

Regards,

Detlew
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2016-05-03 19:44
(2886 d 04:52 ago)

@ d_labes
Posting: # 16274
Views: 8,092
 

 Bioequivalence study

Dear Detlew,

❝ To be not bounded by an document called "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" in his assessment? :-D


Nope. The guess of nobody above was correct. Let me highlight the relevant part:
"GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE"
We are performing a comparative bioavailability study (the experiment) and are hoping for bioequivalence (the desired result).
The assessor describes his hobby like this: “If you already know the result (bioequivalence) why do you want to perform a study?” ;-)

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d_labes
★★★

Berlin, Germany,
2016-05-04 10:43
(2885 d 13:53 ago)

@ Helmut
Posting: # 16279
Views: 7,877
 

 Investigation of ...

Dear Helmut,

❝ We are performing a comparative bioavailability study (the experiment) and are hoping for bioequivalence (the desired result).


Up to now my understanding of a bioavailability study was: A study with the aim to study the extent of availability in the body, without the aim to show equivalence. F.i. intra-venious application versus oral.

❝ The assessor describes his hobby like this: “If you already know the result (bioequivalence) why do you want to perform a study?” ;-)


IMHO this is a very sophisticated and nitpicking attitude, suitable to wow NLYW :-D.
In the same spirit you can't speak about non-inferiority or superiority studies.
But: "Jedem Tierchen sein Pläsierchen" (rough translation "To each their own"). Especially if it (the beastie) is an assessor.

Regards,

Detlew
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