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RegisterDraft FDA Guidance Dec 2013 [Regulatives / Guidelines]
Hi,
"A replicate crossover study may be an appropriate alternative to the parallel or nonreplicate crossover study described above, and can be conducted as either a partial (three-way) or full (four-way) replication of treatment".
how can we replace parallel study by a partial (three-way) or full (four-way) replication? in case of long half life drugs.
In case of warfarine OGD guidlines.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201283.pdf
Warfarin has a long terminal elimination half-life. Please ensure adequate washout periods between treatments in the crossover studies. For long half-life drug products, an AUC truncated to 72 hours may be used in place of AUC0-t or AUC0-∞, as described in the Guidance for Industry: “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations”.
Warfarin has low within subject variability",- In OGD itself showing low variability then why suggesting RSAB (i.e. NTI)
Applicants may consider using the reference-scaled average bioequivalence approach for warfarin described below.
warfarine has long half life, FDA suggesting RSAB- ?
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA": in this guidence there is no disscussion about NTI drugs.
Thanks.
KVGR
"A replicate crossover study may be an appropriate alternative to the parallel or nonreplicate crossover study described above, and can be conducted as either a partial (three-way) or full (four-way) replication of treatment".
how can we replace parallel study by a partial (three-way) or full (four-way) replication? in case of long half life drugs.
In case of warfarine OGD guidlines.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201283.pdf
Warfarin has a long terminal elimination half-life. Please ensure adequate washout periods between treatments in the crossover studies. For long half-life drug products, an AUC truncated to 72 hours may be used in place of AUC0-t or AUC0-∞, as described in the Guidance for Industry: “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations”.
Warfarin has low within subject variability",- In OGD itself showing low variability then why suggesting RSAB (i.e. NTI)
Applicants may consider using the reference-scaled average bioequivalence approach for warfarin described below.
warfarine has long half life, FDA suggesting RSAB- ?
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA": in this guidence there is no disscussion about NTI drugs.
Thanks.
KVGR
Complete thread:
- Draft FDA Guidance Dec 2013 pash413 2013-12-04 15:05
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- First impressions Helmut 2013-12-04 16:47
- First impressions nasir 2014-02-14 06:47
- What is Bioequivalence in the US really? ElMaestro 2013-12-07 23:34
- Site of action vs. systemic circulation Helmut 2013-12-08 02:05
- Draft FDA Guidance Dec 2013 drgunasakaran1 2013-12-08 08:39
- Two-stage or RSABE Helmut 2013-12-08 13:59
- Two-stage or RSABE ElMaestro 2013-12-08 14:17
- Two-stage methods Helmut 2013-12-08 14:44
- Two-stage methods ElMaestro 2013-12-08 18:56
- Two-stage methods Helmut 2013-12-08 14:44
- RSABE Lucas 2014-03-24 17:05
- Two-stage or RSABE ElMaestro 2013-12-08 14:17
- Draft FDA Guidance Dec 2013 jag009 2013-12-09 22:31
- Draft FDA Guidance Dec 2013kvgreddy06 2014-02-14 16:44
- Two-stage or RSABE Helmut 2013-12-08 13:59
- End of consultation approaching‼ Helmut 2014-02-26 11:32
- End of consultation approaching‼ wien-ui 2014-03-01 08:05
- End of consultation approaching‼ Helmut 2014-03-01 20:09
- End of consultation approaching‼ wien-ui 2014-03-04 10:53
- End of consultation approaching‼ Helmut 2014-03-01 20:09
- End of consultation approaching‼ wien-ui 2014-03-01 08:05
- First impressions Helmut 2013-12-04 16:47
Ing. Helmut Schütz