A Wealth of Information at Your Fingertips

Altasciences has an extensive understanding and decades of experience in IND/NDA-enabling toxicology, safety pharmacology, and laboratory services that meet global regulatory requirements.

Here are some of our most insightful scientific resources in preclinical development to guide you through every step of the journey:

• Webinars that cover topics related to the potential of miniature swine in preclinical studies, insights for avoiding common pitfalls in early drug development, and effective interpretation of toxicity data for classification.
  • Downsized Miniature Swine: A New Spin on the Oldest Model
  • Navigating the Challenges of Early Drug Development—How to Avoid Common Pitfalls
  • Case Studies Adversity Level Determination in Nonclinical Toxicity Studies
• ​​​​​​The Altascientist — A Scientific Journal that offers insights into the evolving role of miniature swine in preclinical safety studies, effective safety pharmacology practices, and valuable tips for planning successful preclinical assessments to support regulatory submissions.
  • A Changing Paradigm for Non-rodent Species in Nonclinical Safety Studies
  • Safety Pharmacology Studies - a Review
  • Navigating the IND Submission Process
• eBooks that help you navigate the preclinical regulatory process, identify key milestones for accelerated drug development, and delve into dermal testing solutions.
  • Nonclinical Assessment Planning Guide
  • Scratching the Surface of Dermal Testing

VISIT THE FULL LIBRARY

Speak with an expert today to learn more about our preclinical solution.

Have five more minutes? Check out these web pages:

Preclinical Services
Miniature Swine in Nonclinical Studies

If you missed our latest webinar titled Nonclinical Safety Assessment of Gene Therapy Products, it’s not too late! The on-demand version is now available.

Topics covered include:

•    current trends in the development of gene therapy products;
•    timing of biodistribution studies based on the ICH S12 Guideline;
•    planning considerations and requirements for toxicity studies; and
•    AAVs NAbs pre-dose screening data for animal selection.

Watch it now!
 

If you have questions about your nonclinical cell and gene therapy studies, speak with one of our experts.

You may also be interested in:
eBook: Key Considerations for Cell and Gene Therapy Nonclinical Studies
Scientific Poster: Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors
Scientific Journal: Applications of PCR Analysis for Your Gene Therapy Programs

Essentials for Successful Dermal Safety Testing

Altasciences’ team of preclinical research experts, including toxicologists, veterinarians, and technicians, have extensive experience and a solid understanding of the challenges specific to dermal research. In this eBook, we answer critical questions and highlight key considerations to help you advance your dermal program from discovery through clinical trials to proof-of-concept, and beyond.

You’ll learn about:

•    important factors to consider before starting your dermal research program;
•    questions you can expect our preclinical research team to ask you;
•    the data required for regulatory agencies; and
•    available FDA pathways and how to choose the right one for your molecule.

Ready to begin? Altasciences’ preclinical research team can design and conduct studies that reliably and quickly provide you with the data you need, from initial efficacy work through IND-enabling programs and regulatory submissions. We can develop new dermal models, validate existing ones, and perform GLP and non-GLP toxicology studies to support both 505(b)(2) and new chemical entity regulatory filings. Get started today!

DELVE INTO A SPECTRUM OF PRECLINICAL TOPICS BELOW

Get ready for a must-read experience! We are pleased to share with you seven new scientific posters we presented at the 44^th Annual American College of Toxicology (ACT) Meeting.

Delve into a spectrum of preclinical topics below: 

•    Introducing the Philippine Cynomolgus Macaque (Macaca Fascicularis Philippensis) as a Research Model in Drug Safety Assessment. Yafei Chen, MS, Senior Research Fellow

•    Comparison of Cardiovascular and Respiratory Parameters in Three Strains of Research Pigs; Sinclair Nanopig™, Göttingen Minipig®, and Yucatan™ Miniature Swine. Miri Pannu, MS, Associate Scientific Director

•    Creation of a Swine Model of Oral Angioedema. Kyle Klepner, Senior Study Director

•    Intravenous Sampling and Administration in Rodents: Overcoming Challenges of Using Vascular Access Buttons™. 
Dr. Gabriela Campoy, DVM, Associate Scientist, Study Director

•    Understanding Species Variation in the Occurrence of Spontaneous Background Eye Lesions in Toxicology Studies: A Comparative Study. Dr. Nirmala Chinnappareddy, BVSc, PhD, DABT, ERT, Scientist/Study Director

•    Historical Review of In-Life Data from Preclinical Studies Utilizing AAVs for Gene Therapy. Julie Forget, DESS Tox, DABT, Senior Director Safety Assessment

•    Proposed Best Practices for Optimizing the Number of Animals in Toxicology Studies. Narine Lalayeva, MS, Associate Director, Safety Assessment

Questions? Speak with one of our experts about your small or large molecule preclinical projects. We can get your study started within the next two months!
 
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