Bioequivalence concentrates on for hostile to malarials in the prequalification venture: Outcomes and often experienced

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Tanzania, 21.- 25. Admirable. 2. Rundown of Submissions for Anti-Malaria Drugs (May 2006). MonoArtemether i.m. Inj.11Artemether oral 5Artesunate oral 50mg 8Artesunate oral 100 mg 1Artesunate oral 200 mg 2Artesunate rectal 3Artesunate i.v. Inj. 1Dihydroartemisinin oral 1Amodiaquine 2 (N=34).

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Bioequivalence thinks about for hostile to malarials in the prequalification extend: Outcomes and often experienced insufficiencies Overview and Examples Hans Kemmler Consultant to WHO White Sands, 23.Aug. 2006

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Summary of Submissions for Anti-Malaria Drugs (May 2006) Mono Artemether i.m. Inj. 11 Artemether oral 5 Artesunate oral 50mg 8 Artesunate oral 100 mg 1 Artesunate oral 200 mg 2 Artesunate rectal 3 Artesunate i.v. Inj. 1 Dihydroartemisinin oral 1 Amodiaquine 2 (N=34) Tanzania, 21.- 25. August

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Summary of Submissions for Anti-Malaria Drugs (May 2006) Artemisinin based blends Artesunate/+ Amodiaquine 8 Artesunate/+ Mefloquine 3 Artesunate + S/Pyrimethamin 2 Artesunate/+ Sulfamethoxypyrazin/P 1 Artemether/Lumefantrine 1 DHA/+ Piperaquine 1 N=16 Mono+ Combi N=50 Tanzania, 21.- 25. August

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Status of Submissions for Anti-Malaria Drugs (May 2006) Mono+ Combi add up to entries: N=50 Prequalified: 5 Cancelled: 19 "Dynamic" : 26 (counting rejected entries with new information) All five prequalified items are "trend-setters" (clinical Phase III trials (controlled) finished with the item itself, demonstrating the items viability/wellbeing straightforwardly; pharmacokinetic concentrates additionally present) Tanzania, 21.- 25. August

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Deficiencies in Submissions (Clinical part) First item evaluated July 2002 (this one is not yet prequalified) No accommodation without insufficiencies Not one accommodation for a non specific item with a BE-study given in the primary dossier Tanzania, 21.- 25. August

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Deficiencies in BE Studies Selected case: Artesunate oral measurement frames: 11 dossiers for mono, 14 for mix For 2 items (identifying with 8 dossiers, mono and combi) PK-considers submitted (originators) For 4 items (identifying with 7 dossiers) BE-Studies inevitably accommodated 10 dossiers : Nothing Tanzania, 21.- 25. August

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Results of Artesunate BE Studies Tanzania, 21.- 25. August

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Results of Artesunate BE Studies Tanzania, 21.- 25. August

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Identified Deficiencies in BE studies Major insufficiencies No bioequivalence think about performed and no sufficient support for not playing out a review Unacceptable reference item Inadequate approval information of bioanalytical technique Tanzania, 21.- 25. August

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Identified Deficiencies in BE studies Major insufficiencies (cont.) No check that test item utilized as a part of bioequivalence study is indistinguishable to item planned for advertising 90 % Confidence Intervals for pharmacokinetic parameters not exhibited (or all the more by and large, no sufficient factual examination) Tanzania, 21.- 25. August

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Identified Deficiencies in BE studies Minor lacks (cont.) No data on cluster size of test item Certificate of Analysis of test group not submitted In-vitro disintegration profiles not submitted for test item for reference item for various qualities of a similar item Tanzania, 21.- 25. August

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Thank you for your consideration Tanzania, 21.- 25. August

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