Preclinical Research
Preclinical Strategies in Rodent Studies Using Volumetric Absorptive Microsampling (VAMS®)
We’re Committed to the 3Rs
Through our commitment to the 3Rs and our careful adherence to regulatory guidelines, we maintain an unwavering focus on the welfare of the laboratory animals in our care.
In this podcast series, Dr. Christina Cruzen, Altasciences’ Attending Veterinarian and Chief Animal Welfare Officer, discusses our dedication to the 3Rs.
- Episode #1: The recent advancements made to Altasciences’ 3Rs program.
- Episode #2: Interview with Dr. Megan R. LaFollette, Program Manager at The North American 3Rs of Animals in Research Collaborative (NA3RsC), on the importance of animal welfare, how the role of animal research is changing, and much more.
Speak with Dr. Cruzen to discover how we make animal welfare a constant priority.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept.
You may also be interested in the following:
Video:
Webpage: Preclinical Services
Method for Surgical Closing of Muscle Biopsy Sites on Nonhuman Primates in Group Housing
Expert Support for Your IND/CTA Requirements
|
Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least six months before your required submission date.
For a more detailed discussion of the regulatory planning process, consult our Preclinical Assessment Planning Guide.
|
Moving Your Drug Forward to Preclinical Trials
Your drug discovery phase is nearing completion and your funding is in place. What comes next?
Safety Pharmacology ― Key Considerations for a Successful Study
In this edition of The Altascientist titled Safety Pharmacology Guidelines and Practices, discover how to reduce the use of test animals, save time, and ensure quality data by:
- Combining safety pharmacology studies when appropriate
- Including safety pharmacology endpoints in toxicology studies
Read The Altascientist
Speak with our experts to learn more about our combined cardiovascular/respiratory safety pharmacology capabilities.
You may also be interested in the following:
- Webpage: Preclinical Services
- Fact Sheet: Safety Pharmacology
- Podcast: Science, 3Rs, and Animal Welfare with Dr. Megan R. LaFollette from 3RNA
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
We Deliver Your Projects On-Time.
On-Time Delivery
Over the last 12 months, our project management team has played a key role in achieving a 99% on-time delivery success rate on your primary KPIs.
Altasciences’ high-quality project management is key to the success of your drug development programs, and is an integral part of our service offering. Our project management team has extensive expertise in managing studies for a wide range of therapeutic areas in small and large molecules, and will oversee every aspect of your study.
Partner with us to ensure seamless and timely communication for the successful completion of your project.
You may also be interested in the following:
Webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Ocular Toxicology ― Keeping an EYE on Success
We Share Your Vision
Altasciences has performed safety assessments of test articles administered via numerous ocular routes for over 50 years, including for nanoparticles and ocular implants.
Common routes of administration include, but are not limited to:
- Intravitreal injection
- Subretinal injection
- Anterior chamber injection
- Subconjunctival injection
- Topical instillation
We have supported a significant number of successful global regulatory submissions in terms of study design, conduct, and data integrity. Study durations have ranged from single-dose acute studies to six- and nine-month studies.
You may also be interested in the following:
- Webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Flow Cytometry Solutions to Support Your Preclinical and Clinical Studies
Altasciences’ offers scalable flow cytometry solutions, and leverages extensive knowledge to help ensure a smooth transition from preclinical to clinical studies. We provide you with:
- Dedicated flow cytometry scientists available to you early in the process to help determine the most appropriate strategy for non-GLP, GLP, and GCP testing
- Extensive knowledge with exploratory and GLP studies from panel development to validation
- Design and development of receptor occupancy (RO) assays
- Strategically located laboratories in both the U.S. and Canada.
- State-of-the-art instrumentation
- Rapid turnaround between sample collection and analysis
Altasciences has the same instrumentation in its U.S. preclinical site and Canadian site, which allows assay transfer for easy transition from preclinical to clinical studies.
Download flow cytometry fact sheet
Speak to a flow scientist for guidance on your assay development or validation strategy.
You may also be interested in the following:
- Webpage: Therapeutic Areas of Clinical Research
- Fact Sheet: First-in-Human Trials Capabilities
- The Altascientist: Facing Bioanalytical Challenges
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
The Power of Microsampling in Preclinical Research
As an alternative to traditional venipuncture, blood microsampling represents a less invasive and simplified collection technique, resulting in numerous benefits for preclinical and clinical studies alike.
Microsampling in safety testing supports Altasciences’ commitment to the 3Rs: replace, reduce, and refine experimental animal use. It also provides other advantages, such as:
- Accelerated animal recovery due to rapid blood collection
- Direct correlation of study findings with PD and toxicological effects given the use of main study animals
- Less variability in PK profiles when derived from individual animals versus composite profiling
- Collection of additional PK/TK timepoints
- Biomarkers and metabolites detection that aids interpretation of toxicological effect
- Reduced animal numbers saves on costs and time
Speak with one of our microsampling experts today.
You may also be interested in the following:
- Webpages:
- Videos:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.