A Look at Driving Simulation Clinical Trials
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Drugs that contain psychoactive or sedative pharmaceutical ingredients which could alter the ability to operate a motor vehicle require driving simulation clinical trials. In 2017, the FDA finalized a guidance that proposes a tiered approach to such studies, consisting of pharmacological/toxicological, epidemiological, and standardized behavioral assessments to evaluate possible drug effects on driving, starting early in clinical development. |
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Save Time and Costs with Liquid-Filled Capsules
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Altasciences presents liquid-filled, two-piece capsule services to effectively formulate poorly soluble drugs and supplements, while reducing development time and costs. Liquid filling provides the ability to control R&D compounds, which are expensive and in limited supply. |
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Participant Retention Strategies in Phase I Clinical Trials
In this article, we explore key participant retention strategies in Phase I clinical trials.
Altasciences Full-Service Clinical Trial and Bioanalytical Support
We had the pleasure of working with the Altasciences team on a relative bioavailability study, including clinical pharmacology and bioanalytical analysis, for a treatment for palmoplantar pustulosis (PPP), a rare, chronic inflammatory skin condition with no approved therapy in the United States.
Complimentary Webinar — Critical Sample Handling Processes for Preclinical and Clinical Studies
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Sample management at the test facility or clinical site, including sample collection an processing, is a critical aspect of regulated bioanalysis. This is reinforced in the FDA's final industry guidance on Bioanalytical Method Validation (BMV). For meaningful data, every effort should be made to ensure that the analytes' concentration is maintained, from sample collection to completion of bioanalysis. |
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ON-SITE, ICH STABILITY STORAGE AND TESTING
Equipped with state-of-the-art analytical laboratories and on-site, ICH-compliant stability chambers, our laboratory is ready to handle all your needs.
Our facility offers the standard ICH conditions, as well as custom storage conditions. Our environmental chambers are continuously monitored by Rees Scientific, a centralized monitoring system. Rees Scientific provides us with real-time alerts to ensure samples remain within your desired specifications. All of our stability chambers are on our backup generator.
Current conditions:
- -80 °C
- -20 °C
- 5 °C (walk-in chamber)
- 25 °C/60% RH (walk-in chamber)
- 30 °C/65% RH
- 30 °C/75% RH
- 40 °C/75% RH
METHOD DEVELOPMENT, QUALIFICATION, AND VALIDATION
We have the necessary equipment and experience to perform validations of analytical methods in any formulation, valuable to reduce the development time required to get you to a validated method. This helps accelerate your product to the marketplace.
Our phase-appropriate validation protocols are developed closely with your goals in mind. Our Standard Operating Procedures for validation methods are modeled after the guidelines in the USP chapter of Validation of Compendial Procedures <1225>. Evaluation of key parameters is essential to a robust validation. Accuracy, precision, specificity, detection limit, quantification limit, linearity, range, and robustness are evaluated in each validation procedure.
Cleaning validations are also critical to remain compliant, especially in a multi-product facility. We have years of experience in cleaning validation and can help on- or off-site for your projects. At completion of any campaign, cleaning verifications are performed on all equipment to ensure the cleanliness and removal of any active ingredient and cleaning agent.
Whether you need validation for your API, in-process, or drug product testing, we are here to provide valuable expertise for your project.