This recent guidance from the FDA outlines the necessary evaluations during the clinical development of oligonucleotide therapeutics, including assessments for QTc interval prolongation, immunogenicity risks, and potential drug-drug interactions—and aims to ensure a complete characterization of these drugs' pharmacokinetics, pharmacodynamics, and safety profiles. View the guidance below, or at: https://lnkd.in/ehRJHpYq #ClinicalPharmacology #Guidance #RNA
Altasciences
Research Services
Laval, Quebec 31,542 followers
Quicker go/no-go decisions with integrated preclinical, clinical, bioanalytical, manufacturing, and CRO services.
About us
Outsourcing made easy with a one-stop solution to early phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!
- Website
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http://www.altasciences.com
External link for Altasciences
- Industry
- Research Services
- Company size
- 1,001-5,000 employees
- Headquarters
- Laval, Quebec
- Type
- Privately Held
- Founded
- 1992
- Specialties
- Clinical Research, Clinical Trials, Phase I-II, Human Abuse Liability & Abuse Potential, Early Cardiac Safety & TQT, Biosimilars, Bioanalytical Laboratory, Analytical Services, Toxicology Study, CDMO, Safety Pharmacology, Preclinical Study, GLP / Non-GLP Study, IND-Enabling, NDA Submission, LCMS and LBA, Small and Large Molecule Bioanalysis, Research Support Services, Medical Writing, Clinical Project Management, and Pharmaceutical Manufacturing
Locations
Employees at Altasciences
Updates
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Discover the latest life science resources curated by our experts! From CNS-active compounds and regulatory timeline comparisons for starting first-in-human trials, to sensitive quantitation of ASOs—we’ve got something for you! https://lnkd.in/dUGEgE-p #LifeSciences #DrugDevelopment #CRO #CDMO
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Today, we celebrate the contributions of our talented interns. From preparing reagents and running 10-plex cytokine assays, to assisting in shipment receiving, their hard work and fresh perspectives make an impact on those around them. Here’s to their continued success! #WeAreAltasciences #MovingInUnison #NationalInternDay
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Explore the heart of our three harmonized labs! Witness the essence of our expertise in Part 1 of our video series, where our Laboratory Sciences leadership team sheds light on our commitment to scientific excellence. #DrugDevelopment #LaboratorySciences #WeAreAltasciences
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Dr. Lynne Le Sauteur and her team are in the spotlight in Insights Care’s The Top Most Innovative Bioanalytical Service Providers to Watch! Read how our experts are leading the charge in bioanalytical advancements: https://lnkd.in/dxGi48qz #Bioanalysis #DrugDevelopment #LifeSciences Lynne LeSauteur
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Don't miss out! Watch this on-demand webinar on which we collaborated with Cambridge Cognition to learn about the important role of cognitive and pharmacodynamic testing in first-in-human (FIH) trials for novel CNS-active drugs: https://lnkd.in/gVcMjVAv Key topics include: • selecting the right cognitive and pharmacodynamic tests for your CNS-active drug; • understanding the most relevant populations for testing; and • leveraging cognitive and pharmacodynamic data to shape your drug development and regulatory strategies. #DrugDevelopment #ClinicalTrials #CNS
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The shortest distance from preclinical to clinical is Altasciences, a single provider for both phases—focused on early-phase drug development, including CDMO capabilities and bioanalytical labs. #DrugDevelopment #ClinicalTrials #Nonclinical
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Preclinical manufacturing involves a series of sub-processes, all of which are critical to your overall drug development. In Issue 38 of The Altascientist, we explore critical considerations for formulation development and manufacturing for preclinical testing, and the strategies we employ to support your projects. Topics covered include: - pre-formulation development - biopharmaceutical assessments - drug product manufacturing - quality control procedures - regulatory aspects - risk management Read the journal or listen to the audiobook: https://lnkd.in/ddAv99-F #DrugDevelopment #LifeScience #Nonclinical
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How can you mitigate challenges that arise in your ophthalmic drug development program? By partnering with Altasciences, an integrated CRO/CDMO. We can safely advance your product seamlessly through each development phase with accelerated timelines and cost savings, ease of data transfer, reduced handoffs, and fewer logistical challenges. Learn how our end-to-end ophthalmic drug development solutions optimize your program and get your products to market, faster: https://lnkd.in/dfaXBFeN
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We’re gearing up for the 4ᵗʰ Annual mRNA-Based Therapeutics Summit in Boston! Booth #34 As a leading CRO/CDMO, our services simplify your drug development journey to market. With a comprehensive understanding of FDA regulations and requirements for vaccine approval, and a large database of study participants, we are uniquely positioned to streamline the clinical development of new vaccines and delivery systems. Pre-book your preferred meeting time now: https://lnkd.in/d9CJy8Eh #mRNATherapeutics #Preclinical #Toxicology Meghan Lancaster Michael Olson