Practical problems in regulatory toxicology I ：Formulations
Although highly regulated, all non-clinical toxicology studies have the potential to experience practical prob- lems. Anticipation of potential hurdles and...Practical problems in regulatory toxicology I ：Formulations
Although highly regulated, all non-clinical toxicology studies have the potential to experience practical prob- lems. Anticipation of potential hurdles and planning for success are key actions for all investigators to ensure a study is ro- bust and suitable for submission and regulatory acceptance. This presentation will examine an area of study conduct which can be problematic but which if approached correctly will ensure good study conduct. Many test materials under develop- ment today are insoluble. Achieving a suitable formulation for administration to laboratory animalsis difficult and therefore having strategies for determining suitable vehicles and dosing regimen essential. To achieve the optimal bioavailability of the chemical you need to strike a balance between the dose concentration, dose volume and the dosing regimen. The presentation will consider the interactions of factors such as the physical nature of the final formulation, physicalproperties of vehicles and potential side effects which should be considered together when optimising the final dosing formulation. It will demonstrate how a methodical approach can assist the scientist in establishing a formulation that will achieve the best bioavailability possible with minimal effects to the test animal. The presentation will also illustrate how the Study Director can demonstrate strong involvement and active study management as required by the GLP authorities.展开更多
文摘Practical problems in regulatory toxicology I ：Formulations
Although highly regulated, all non-clinical toxicology studies have the potential to experience practical prob- lems. Anticipation of potential hurdles and planning for success are key actions for all investigators to ensure a study is ro- bust and suitable for submission and regulatory acceptance. This presentation will examine an area of study conduct which can be problematic but which if approached correctly will ensure good study conduct. Many test materials under develop- ment today are insoluble. Achieving a suitable formulation for administration to laboratory animalsis difficult and therefore having strategies for determining suitable vehicles and dosing regimen essential. To achieve the optimal bioavailability of the chemical you need to strike a balance between the dose concentration, dose volume and the dosing regimen. The presentation will consider the interactions of factors such as the physical nature of the final formulation, physicalproperties of vehicles and potential side effects which should be considered together when optimising the final dosing formulation. It will demonstrate how a methodical approach can assist the scientist in establishing a formulation that will achieve the best bioavailability possible with minimal effects to the test animal. The presentation will also illustrate how the Study Director can demonstrate strong involvement and active study management as required by the GLP authorities.
