Gowthami ☆ India, 2017-04-25 14:13 (2551 d 21:32 ago) Posting: # 17262 Views: 2,772 |
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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 (2551 d 20:13 ago) @ Gowthami Posting: # 17263 Views: 2,325 |
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"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 |