Considerations for Deriving Health-Based Exposure Limits for Active Pharmaceutical Ingredients

In June 2015, a guideline published by the European Medicines Agency came into force (EMA/CHMP/CVMP/SWP/169430/2012).  This guideline outlines requirements and methods for establishing health-based exposure limits for active pharmaceutical ingredients (APIs) related to carryover contamination of one API into another API or drug product.  The health-based exposure limit is referred to as the permitted daily exposure (PDE) value, and its derivation requires consideration of toxicology/safety data, pharmacology (efficacy) data, the route(s) of exposure, and other information.

This webinar will provide an overview of numerous points to consider when deriving a PDE value for an API.  These include identifying relevant data, selecting a point of departure, and applying appropriate adjustment factors to derive a PDE value, as well as requirements for documenting the overall process and other factors.  Attendees of this webinar will have a better understanding of why, how, and when to derive PDE values for APIs.

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En juin 2015, une ligne directrice publiée par l'Agence européenne du médicament (EMA) est entrée en vigueur (EMA / CHMP / CVMP / SWP / 169430/2012). Cette ligne directrice décrit les exigences et les méthodes à appliquer afin d’établir des limites d'exposition pour la santé humaine de principes actifs pharmaceutiques (API) liées à la contamination croisée d'un API ou d’un produit pharmaceutique par un autre API. Cette dose limite est appelée limite d’exposition permissive journalière (Permitted Daily Exposure ou PDE) et son calcul nécessite la prise en compte des données de toxicologie / d’innocuité, des données pharmacologiques (efficacité), des voies d'exposition et d'autres informations sur l’API.

Ce webinar fournira un aperçu des nombreux points à considérer lors du calcul d'une valeur de PDE pour un API. Ceux-ci comprennent l'identification des données pertinentes, la sélection d’une valeur de départ (Point of Departure ou PoD) et l'application de facteurs de sécurité appropriés pour calculer une valeur de PDE, ainsi que les exigences pour documenter le processus global et d'autres facteurs. Les participants à ce webinar comprendront mieux pourquoi, comment et quand calculer des valeurs de PDE pour les API.

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In June 2015, a guideline published by the European Medicines Agency came into force (EMA/CHMP/CVMP/SWP/169430/2012).  This guideline outlines requirements and methods for establishing health-based exposure limits for active pharmaceutical ingredients (APIs) related to carryover contamination of one API into another API or drug product.  The health-based exposure limit is referred to as the permitted daily exposure (PDE) value, and its derivation requires consideration of toxicology/safety data, pharmacology (efficacy) data, the route(s) of exposure, and other information.

This webinar will provide an overview of numerous points to consider when deriving a PDE value for an API.  These include identifying relevant data, selecting a point of departure, and applying appropriate adjustment factors to derive a PDE value, as well as requirements for documenting the overall process and other factors.  Attendees of this webinar will have a better understanding of why, how, and when to derive PDE values for APIs.

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In June 2015, a guideline published by the European Medicines Agency came into force (EMA/CHMP/CVMP/SWP/169430/2012).  This guideline outlines requirements and methods for establishing health-based exposure limits for active pharmaceutical ingredients (APIs) related to carryover contamination of one API into another API or drug product.  The health-based exposure limit is referred to as the permitted daily exposure (PDE) value, and its derivation requires consideration of toxicology/safety data, pharmacology (efficacy) data, the route(s) of exposure, and other information.

This webinar will provide an overview of numerous points to consider when deriving a PDE value for an API.  These include identifying relevant data, selecting a point of departure, and applying appropriate adjustment factors to derive a PDE value, as well as requirements for documenting the overall process and other factors.  Attendees of this webinar will have a better understanding of why, how, and when to derive PDE values for APIs.

DOWNLOAD