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riktlinjedokumentets titel conduct of pharmacokinetic studies in
emea/cpmp/phvwp/2058/99
Letzte Aktualisierung: 2011-10-23
Nutzungshäufigkeit: 1
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concept paper on the development of a cpmp note for guidance on the clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins.
concept paper for the development of the revision of the cpmp note for guidance on evaluation of new anti-bacterial medicinal products (cpmp/ewp/558/95) and the cpmp note for guidance on the pharmacodynamic section of the spc for anti-bacterial medicinal products (cpmp/ewp/520/96)
Letzte Aktualisierung: 2011-10-23
Nutzungshäufigkeit: 1
Qualität:
choice of delta points to consider on the requirements for clinical documentation for metered dose inhalers addenda for neuropathic pains to be considered clinical investigation of hypnotic medicinal products clinical investigation of medical products in the treatment of generalised anxiety disorder, panic disorder and obsessive- compulsive disorderrevision note for guidance on anthiarrhythmics note for guidance on clinical investigation of steroid contraceptives in woman clinical investigation of corticosteroids intended for use on the skin note for guidance on pharmacokinetic studies in man points to consider on live attenuated influenza vaccines guidance on requirements for pharmaceutical/ clinical documentation for cell culture influenza vaccines points to consider on xenogeneic cell therapy note for guidance on comparability of medicinal products containing biotechnology- derived proteins as active substance note for guidance on the use of medicinal products during pregnancy: need for post- marketing data note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling revision of the note for guidance on harmonisation of requirements for influenza vaccines
note for guidance on pharmacokinetic studies in man points to consider on live attenuated influenza vaccines guidance on requirements for pharmaceutical/ clinical documentation for cell culture influenza vaccines points to consider on xenogeneic cell therapy note for guidance on comparability of medicinal products containing biotechnology-derived proteins as active substance note for guidance on the use of medicinal products during pregnancy: need for post-marketing data note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling revision of the note for guidance on harmonisation of requirements for influenza vaccines
Letzte Aktualisierung: 2011-10-23
Nutzungshäufigkeit: 1
Qualität: