Gowthami
☆    

India,
2017-04-25 14:13
(2529 d 09:14 ago)

Posting: # 17262
Views: 2,698
 

 Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study [Regulatives / Guidelines]

Hi all,

As per the OGD recommendation of Naloxone hydrochloride nasal spray, FDA has recommended two options as follows:

Two options: In vivo or In vitro.

Strengths: 2 mg/spray & 4 mg/spray

As our product is not qualitatively (Q1) and quantitatively (Q2) the same as the reference (R) product and the nasal spray device (e.g., the pump and actuator design) of our product is appropriate for approval in an ANDA, we are planning to conduct bioequivalence (BE) of the T product to the R product.

OGD recommendation: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM554404.pdf

As per the FDA recommendation, we need to prove the Bioequivalence based on Log-transformed AUC0-t, AUC0-inf, and Cmax. Other than these PK parameters, FDA also recommending to submit partial AUC of early time points as supportive data to assess the onset of naloxone effect. Applicants should collect sufficient quantifiable PK samples to allow a comparison of exposure to naloxone between the T product and the R product within the initial 4 minutes, first 10 minutes, and 10-30 minutes after administration.

I think partial AUCs may be as AUC0-4min, AUC0-10min and AUC10-30min.

Kindly any one can explain the FDA rationale behind the selection of these pAUCs.

Best Regards,
Gowthami :-)
nobody
nothing

2017-04-25 15:31
(2529 d 07:55 ago)

@ Gowthami
Posting: # 17263
Views: 2,267
 

 Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study

"NARCAN nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose..."

...so every second counts. No question.

Kindest regards, nobody
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
78 visitors (0 registered, 78 guests [including 7 identified bots]).
Forum time: 22:27 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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