Rigorous Sample Handling Processes
Regulatory Guidance
Ensuring that current and relevant FDA and EMA guidances are applied to the handling of bioanalytical samples during clinical tria
ISSUE NO. 14 — Central Nervous System
As you work towards a successful New Drug Application (NDA) submission, there are many considerations that must be taken into account, specifically for central nervous system (CNS)-active drugs. Molecules or compounds that are centrally active (the parent drug or metabolite[s]), may require additional evaluations to characterize the drug effects and unique safety characteristics.
Not all centrally acting drugs require additional assessments; however, strategic direction early in a drug development program can help determine whether such studies should be planned or can be waived.
In Issue 14 of The Altascientist, we look into the complex considerations of CNS-active drugs, including:
- The landscape of CNS-active drug studies
- Drug scheduling and the Controlled Substances Act (CSA)
- Reviewing data from early-phase preclinical and clinical studies
- Choosing a CRO for CNS studies
THE IMPORTANCE OF CLINICAL STUDIES FOR CNS-ACTIVE DRUGS
CNS-active drugs have unique attributes that necessitate additional specialized study, such as:
From Lead Candidate to In-life Use
From Lead Candidate to In-life Use – Manufacturing Drugs from Formulation Development to Commercialization
Podcast Speakers:
Steve Schweibenz, President, Manufactur
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.
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.