NK
☆    

India,
2019-06-26 07:25

Posting: # 20360
Views: 417
 

 Baseline sampling [Regulatives / Guidelines]

Hello everyone,

I have a question with regards to FDA OGD guidance of Dihydroergotamine Nasal Spray" dated February 2019.

The guidance specified that "baseline corrected PK data of AUC and Cmax should be used for bio-equivalence calculation"

As per my understanding, Dihydroergotamine is neither endogenous nor available in the diet, then why baseline value is required?

If it is required, what should be baseline sampling time points (-1h or -30 min or -15 min ...)?

Thanks in advance.

Regards
NK


Edit: URL corrected. [Helmut]
Helmut
★★★
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Homepage
Vienna, Austria,
2019-06-26 10:10

@ NK
Posting: # 20361
Views: 360
 

 Dihydroergotamine Nasal Spray

Hi NK,

» The guidance specified that "baseline corrected PK data of AUC and Cmax should be used for bio-equivalence calculation"
» As per my understanding, Dihydroergotamine is neither endogenous …

Correct.

» … nor available in the diet, …

Oh yes! Even when, it would practically not absorbed.

» … then why baseline value is required?

IMHO, a bizarre idea. Ask the FDA.

» If it is required, …

It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR.

» … what should be baseline sampling time points (-1h or -30 min or -15 min ...)?

The FDA’s general approach for a stable baseline is subtracting the mean of {-1 h, -0.5 h, pre-dose}. In your case likely it would be BQL anyhow. ;-)

Cheers,
Helmut Schütz
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ElMaestro
★★★

Belgium?,
2019-06-26 12:47

@ Helmut
Posting: # 20363
Views: 340
 

 Dihydroergotamine Nasal Spray

Hi all,


» » If it is required, …
»
» It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR.

It would be an interesting lawsuit, if the company gets an RtR for lack of baseline correction and sues the FDA because the formal requirement is meaningless.
Perhaps a case where FDA could hide behind the fact that it is a draft and contains nonbinding recommendations blahblah?

I could be wrong, but...
Best regards,
ElMaestro
nobody
nothing

2019-06-26 10:21

@ NK
Posting: # 20362
Views: 356
 

 Baseline sampling

Sorry, but

Copy -> Paste -> Nonsense on behave of the FDA as the most likely explanation?

We will never know unless someone asks the oracle in Silver Springs, Maryland?

Kindest regards, nobody
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