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
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
Complete thread:
- Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE studyGowthami 2017-04-25 12:13 [Regulatives / Guidelines]
- Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study nobody 2017-04-25 13:31