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.

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.

Contact us

You may also be interested in the following:

Webpages:

• Full-Time Equivalent Capabilities
• Tell Us Once™
• Clinical Trial Services

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 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.

Speak with an expert today.

You may also be interested in the following:

• Webpages:
  • Preclinical Services
  • Bioanalytical Services
  • Clinical Services
  • Manufacturing and Analytical Services

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.

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.

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:
  • Microsampling Benefits
  • Preclinical Services
• Videos:
  • Altasciences’ Animal Welfare Program
  • Your Road to Proactive Drug Development with Altasciences

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.

If you are struggling with getting SEND data, Altasciences can help. Our personable and accessible SEND team is ready and able to answer your questions throughout your SEND process.

As an active member of the CDISC SEND Consortium and Pharmaceutical User Software Exchange (PhUSE) nonclinical working groups, Altasciences contributes to the development of SEND standards and remains at the forefront of these evolving requirements.

Contact a SEND expert today and start saving time.

You may also be interested in the following:

• SEND FAQs: Ask These SEND Questions First 
• Webinar: From Guides to Rules and How They Impact Your SEND Requirements 
• Scientific Publication: The FDA Animal Rule and Standard for Exchange of Nonclinical Data (SEND)
• Webpages:
  • Preclinical Solutions
  • Bioanalytical Solutions

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.

With over 25 years’ experience conducting safety assessment, Altasciences’ preclinical facility in Seattle offers a wide array of solutions, including IND/CTA and NDA-enabling safety assessment, as well as laboratory services for both small and large molecules. 

In this 210,000-square-foot, purpose-built facility, Altasciences can thoroughly assess the safety of your molecules with a full range of in vivo GLP and non-GLP preclinical evaluation studies in both rodent and non-rodent species. We’ve conducted over 2,400 safety studies at this site, which features:

• 140 custom-design animal rooms, including European housing 
• 4,500 sq.-ft. archive facility 
• Capacity to house ~3,000 NHPs, ~500 Canines, ~100 Swine, ~12,000 Rodents, ~800 Rabbits
• AAALAC accreditation 
• USDA registration
• OLAW assurance
• BSL-2 certification

Catch a glimpse of the facility here.

Request a full virtual tour of our Seattle site or contact us for more information on our newest preclinical site in Scranton.

You may also be interested in the following:

• Webpage: Preclinical Drug Development Solutions
• Podcast: Science, 3Rs, and Animal Welfare with Dr. Megan R. LaFollette from 3RNA
• Webinar: Comparison of  the U.S. FDA and Health Canada CTA submission Process to Support First-in-Human Phase I Studies

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.

As your drug development partner, we have a deep appreciation of both the challenges and the potential of your small molecule. At Altasciences, we understand why developing your molecule requires tailored solutions at every stage. 

Find out how our small molecule solutions help identify new and improved approaches to study designs, and anticipate development challenges as studies evolve. 

Bring us your challenge. We have the solution.

Challenge us

You may also be interested in the following:

• Factsheet: Small Molecule Safety Assessment
• IND/CTA Guide: Planning your Preclinical Assessment
• Webpage: Bioanalytical Services

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.