Aptuit’s Toxicology and Safety Pharmacology Support group offers a wide range of analytical support for dose formulation samples, including Suspensions, IV, Purkinje, hERG, and Genotox. We develop and validate drug specific methods for specific matrices. Our laboratories operate under GLPs and can perform validations in accordance with OECD and FDA guidelines.
Some of the areas of support include:
Method Development
Development of the methods necessary to support the various dose formulation samples can vary from simple modification of an API method to complete method development, including selection of appropriate analytical techniques and detection methods. In addition, the methods will be optimized for each vehicle.
Method Validation
We create methods that are flexible to meet the client’s expectations for system suitability requirements and validate these methods using a validation plan. Components of the validation include: linearity, accuracy, precision, specificity, and sample and solution stability. Depending upon expectations, we can modify the plan as necessary.
Formulation Homogeneity and Stability
Some clients request that homogeneity and stability on dose formulations be performed as a separate GLP study after the completion of the method validation. Our study directors are trained to supervise the technical conduct of the study. For suspensions, we determine homogeneity across the concentration range. Additionally, we determine stability on the dose formulation at several storage conditions, over several time points. We can modify the conditions to meet the needs of our clients.
Dose Analysis
We strive to analyze the dose formulation samples by the validated method the day that they arrive. Samples are analyzed per the study protocol under the direction of a principal investigator. The principal investigator will work on behalf of the study director to ensure that the samples are appropriately analyzed according to the method.
End of Study Potency Support
To ensure stability of the test article, some clients choose to perform potency analysis at the completion of the in-life portion of the study. Potency determination is done using an API method that has been either transferred or validated at Aptuit.