Collaborating for Success Tips for Improving Partnerships Between QA and Clinical Operations at Your Site
Risk-Based Auditing and its Application to GLP Computerized System Validation Procedures
ISSUE NO. 39 — Considerations for Nonclinical Dermal Studies: Advancing to Phase I
An increasing number of advanced methods for dermal drug delivery contribute to successful 505(b)(2) applications and extend the patent life of a drug for its sponsor. As a result, new medications and innovative approaches are continually being designed specifically for dermal delivery, creating new marketing opportunities for sponsors, including those developing previously marketed drugs.
Surveys have shown that patients prefer dermal routes of administration, and so dermal and transdermal drug delivery systems (TDDS), also known as patches, can provide greater patient compliance, ease of administration, and convenience—especially for conditions in which chronic use is necessary.
As is the case with all drug products, dermal therapeutics require stringent safety testing and regulatory compliance. By leveraging new methodologies, researchers are paving the way for more effective, patient-friendly options, providing the expertise and resources necessary to navigate this complex but promising landscape.
Issue 39 of The Altascientist explores the nonclinical prerequisites and considerations for advancing dermal programs to Phase I clinical trials—and addresses the challenges of efficiently delivering drugs to the skin's multi-layered structure.
This issue includes:
Reuters: Flipping the Drug Development Industry on Its Head
Disrupting the CRO Model: Altasciences Participates in Documentary Series for 2024 Global Health Summit
Altasciences is leading the conversation on change in the drug development industry as part of a new documentary series for the 2024 Global Health Summit, hosted alongside the WHO’s 77th World Health Assembly in Geneva in May. The mini documentary explores transformation in the slow-to-change drug development industry.
Up Close and Personal With Eryn Corriveau, MSc, Senior Director, Drug Development and Regulatory Strategy
Here at Altasciences, Eryn is responsible for guiding regulatory strategies, conducting gap analyses, and leading interactions with regulatory agencies dur
ing early drug development.
ISSUE NO. 38 — Achieving Optimal Preclinical Formulation and Drug Product Manufacture
Formulating and manufacturing drugs for preclinical testing is an early—and necessary—step towards pushing your molecule through to human clinical trials. At the preclinical stage, the goal is to maximize exposure for safety testing, formulating the limits of solubility and maximum volume. To optimize the formulation for preclinical testing, it’s important to consider the following for informed decision-making regarding feasibility, scale-up, and the future success of your program: route of administration, excipients selection, stability testing, scale-up plans and options, and contingency plans.
Issue 38 of The Altascientist explores the key considerations for successful formulation development and manufacture for safety assessment, alongside examining the strategies Altasciences employs to support you in planning your program.
Preclinical manufacturing involves various sub-processes, all of which are critical in overall drug development. And in this issue, you will discover these sub-processes in detail, including:
- formulation development
- manufacturing process development
- scale-up
- process validation
- analytical method development and validation
- quality assurance and control
- stability studies
- regulatory compliance
- risk management
Also included is a case study about how Altasciences helped a client get their new
Three Platforms Used to Monitor Cytokines and the Complement System
Monitoring both cytokines and complement factors in drug development has become increasingly important, as the movement toward personalized treatments for cancers and genetic diseases has spurred research and development into biologics, vaccines, and small molecules that can have unintended consequences due to their immunomodulatory effects.