EU Marketing Authorisation Procedures Registration Dossier Expert 欧盟的上市许可程序的注册档案专家.ppt

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EU Marketing Authorisation Procedures Registration Dossier Expert 欧盟的上市许可程序的注册档案专家.ppt

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EU Marketing Authorisation Procedures Registration Dossier Expert 欧盟的上市许可程序的注册档案专家

In drug assessment Work interdisciplinary Everything must be evaluated from every angle! (A fulsih exampleon the next slide) ?Everything must be evaluated form every angle”! Structure elucidation of new APIs – see the 3D structure! Structure elicidation of new APIs 3D structure Elucidation (abs. and rel.) – but not enough! Assessment: other structure also present ?impurity characterisation Racemate or one single? (issue, ?PK, ?PD) corporate decision: reveal it – hide it until PP expires? citalopram – escitalopram Stereochem. stability If rapid interconversion: in vivo also possible ?metabolism If slow interconversion: take it into consideration at PD and PK for the other form may have different action or at the toxicity studies (3 months + peri- és postnatal, minimum in 1 dose), as well as at planning human clinical trials Physical structure Particle size (issue: dosage-form, significance?) Dissolution, bioavailability? (PK) During the processing? Stability? Content Uniformity (API-content in dosage-form units)? appearance? ?Impurity rule”, ICH Unknown impurity should be noted: max. daily dose ?1 g: 0.1%; ?1 g: 0.05% Impurity should be identified: max. daily dose ?1 mg: 1%; 1-10 mg: 0,5%; 10 mg-2 g: 0.2%; ?2 g: 0.1% Impusity must be toxicologically characterised: max. daily dose ?1 mg: 1%; 1-100 mg: 0.5%; 100 mg-2 g: 0.2%; ?2 g: 0.15% Quality evaluation Drug analysis! Toxic degradation products, 1) Acetilsalicylic acid (everobody knows?) cefalosporins oxitetracyclin PAS Fat emulsions... Tetracyclin and its one toxic degradation product Quality evaluation 2) Anaphylactoid reactions of degradation products corticosteroids penicillins The ampicillin story Studies in a Swiss hospital pharmacy Corticosteroid-protein interaction The ampicillin-story Hungary, the early 80’s. The Paediatric Clinic (Budapest) notifies the regulatory authority: after administration of the (Bulgarian) Ampicillin injection there was a temperature elevation in children. It nev