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développement clinique d'un médicament
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Tableau des différentes phases et étapes du développemet clinique d'un médicament.
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Phase I II III IVQuand ? pré-AMM pré-AMM pré-AMM post-AMM
- 1ère fois chez l’homme
- coute cher
Particularité - Succède devlpt pré-clinique - commercialisé
- Obtention AMM a la n
- Choix molécule
Participants 10s volontaires sains 100s patients 1000s patients 10.000s patients
❖ TOLERANCE CLINIQUE ET
BIOLOGIE
- relat° doses/effets
indésirables
- Relat° effets/concentrat° ❖ EFFICACITÉ ET
plasmatiques TOLÉRANCE A COURT ❖ EFFICACITÉ ET
- Rechercher dose maximale TERME TOLÉRANCE A LONG
❖ EVALUAT° DANS CONDIT°
tolérée - Ef cacité thérapeutique TERME
USUELLES DE
❖ PHARMACOCINÉTIQUE par relat° effets/doses - ef cacité et tolérance
PRESCRIPT°
- Devenir produit ADME pharmacodynamique comparé au traitement de
- ef cacité et tolérance
Objectif principal - Déf paramètres cinétiques - Choix dose optimale ( dans réf ou placebo
- Incidence effets
et devenir apres gamme dose limitée ) - Étude interactions
indésirables rares
administrat° - Tolérance médicamenteuses
- Béné ces termes
- Linéarité cinétique et - Pharmacocinétique ADME potentielles
pharmaco-économiques
variabilité ( effet maladie/produit ) - evaluat° effets sur patients
❖ PHARMACODYNAMIE - Détermination forme à risques ( âgés, IR, IH )
- Mécanisme d’action galénique dé nitive
pharmacologique
- relat° effets/doses +
effets/concentrat°
plasmatiques ( PK-PD )
- (-) concentré -> (+)
- (-) concentré -> (+)
concentré
concentré
Méthodologie - test avec placebo ou
- Dose unique -> doses
traitement réf ( tirage au
répétées Y.M.
sort et en double aveugle )
fi fi
fi fi
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