[Video] Ethnobridging Studies
Watch the Ethnobridging Webinar On‑Demand
Altasciences recently released a webinar on ethnobridging studies in which Dr. Affrime demonstrates how ethnobridging can help minimize time lags in development of drugs destined for Asian markets. Included are detailed case studies on how to include ethnobridging in your early clinical development plans to safely speed up worldwide regulatory approval.
To learn how Altasciences can assist you with your clinical research program, contact us today!
You may also be interested in the following webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Up Close and Personal With Marie-Hélène Raigneau, MBA, Co-Chief Operating Officer
Marie-Hélène has been a leader in the drug development industry for close to 20 years.
Checklist for a Successful First-In-Human Trial
Planning Your First In Human Trial
Check out this issue of The Altascientist for your roadmap to successfully conducting FIH studies, including:
- Determining the necessary regulatory interactions
- Selecting the starting dose
- Designing the trial
- Planning for participant safety
- Identifying and mitigating potential risks
- Recruiting, educating, and retaining study participants
- Planning resources and conducting the trial
You may also be interested in the following:
Webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Making Sense of Antisense Oligonucleotides (ASOs)
ASOs — The Importance of Sensitive Bioanalytical Assays
Precise quantitation of ASOs helps you target the source of a disease’s pathogenesis. Chemical modifications of ASOs and advancements in drug delivery have improved drug stability and potency, reducing the requirements for quantity of drug per dose, and total number of doses.
Altasciences has expertise in the development of highly sensitive bioanalytical assays for the quantitation of ASOs in complex biological matrices such as eye, liver, or brain tissue, adapted to the different critical parameters of your preclinical or clinical study:
- The ability to quantitate ASOs to very low concentrations impacts calculation of half-life; more sensitive assays will produce more accurate readouts.
- Timepoints close to the end of the dosing cycle are expected to have lower concentrations in various tissues. Highly sensitive methods will produce the most accurate readings, allowing for an accurate PK profile even in late timepoints.
- Hybridization-based methods provide the best reported assay sensitivity and throughput, compared with other bioanalytical methods for ASOs. They are less time consuming, requiring little or no sample clean-up, and have been widely used for the quantitative analysis of ASOs to support both TK and PK regulated bioanalysis.
Take a deeper dive into our ASO capabilities and knowledge, and consult our two case studies, in the 12th issue of The Altascientist.
Want more info?
- Webpage: Comprehensive Bioanalytical Services
- PDF: Altasciences' Proprietary Bioanalytical Assay List
- Podcast: Three Laboratories — One Vision
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Safety Pharmacology Case Studies, Webinar On-Demand
You Won’t Want to Miss This Video!
Watch as, Dr. Michael R. Gralinski, CEO of CorDynamics, reviews the results of three GLP safety pharmacology validation studies.
The studies were conducted using telemetered dogs with well-characterized hemodynamic, electrocardiographic, and respiratory positive controls. All three studies demonstrated the ability to detect expected effects of positive controls with a high degree of reliability.
The studies were conducted in Altasciences' purpose-built, isolated telemetry facility, with data review and interpretation by CorDynamics.
Speak with one of our experts today.
You may also be interested in:
• The Altascientist: Scientific Journal Issue 13 — Safety Pharmacology Studies, a Review
• Fact Sheet: Safety Pharmacology
• Webpage: Safety Pharmacology Overview and FAQs
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Endpoints News: Canadian CRO Altasciences Kicks Off Client Manufacturing Expansion in Philadelphia
eBook – Monitoring Key Biomarkers of Immunomodulation
Altasciences has published a new eBook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
With the movement toward personalized treatments having immunomodulatory effects, monitoring complement factors and cytokines has become increasingly important to help prevent any unintended consequences that may arise from these new medications.
Contents include:
- REVIEW: Complement Factors and Cytokines
- SOLUTIONS: Biomarker Analysis
- CASE STUDY: Comparing Cytokine Data to In-Life Parameters on Nonhuman Primates in Nonclinical Toxicology Studies
- STUDY OUTLINE TEMPLATE: Nonclinical Study
Altasciences has been delivering excellence in bioanalytical services for over 25 years, and is fully equipped to analyze a comprehensive range of biomarkers to support your nonclinical toxicology programs. With over 260 scientists working in state-of-the-art laboratories and shifts running 24/7, as needed, our laboratory teams are able to process as many as 60,000 samples per month.
You may also be interested in the following:
- Poster: Multiplexed Cytokine Comparison Across Two Species Dosed With the Same Drug
- Poster: Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development 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.
Industry Expert Talks First-In-Human and Complex Clinical Trials
A Chat with Dr. Morelli
Altasciences has decades of experience designing, conducting, and reporting on early phase clinical trials. We have the scientific expertise and seamless operational processes to deliver quality data with speed and ease.
Watch as Dr. Morelli, Chief Medical Officer, shares his first-hand experience and insight into Altasciences’ planning and conduct of your first-in-human, complex, and innovator clinical trials.
Want to know more? Speak with an expert about your FIH and other clinical research needs.
You may also be interested in the following:
Webpages:
- First-In-Human Clinical Trials
- Comprehensive Early Clinical Development Solutions
- Altasciences’ State-of-the-art Clinical Trial Facilities
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
June 2022
Our Altascientists are hard at work, whether it’s on your drug development projects, or producing insightful scientific resources to share their knowledge with you. Catch up on what you may have missed, or revisit some highlights from the last three months. |
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A Message from Our CEO to You News: Altasciences Receives CRO Leadership Award in All Five Categories! eBook: One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs Blog: The Impact of Social Factors on Drug Development |
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Five New Scientific Posters Presented at SOT 2022:
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Blog: Five Facts About Psychedelics for Mental Health Quick Chat: Experts in Complex Clinical Trials (with Dr. Morelli, MD) On-Demand Webinar: Inside the Pharmacodynamic Toolbox On-Demand Webinar: Ethnobridging in Phase I Clinical Trials |
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Quiz: Test Your Knowledge of Liquid-Filled Capsules Case Study: Rapid Development of a Liquid-Filled, Hard-Shell Capsule Formulation of Cannabidiol Podcast: Episode #24 ― The Importance of a CDMO Consultant Quick Chat: Manufacturing and Handling Your Highly Potent APIs and Controlled Substances (with Ben Reed) |
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eBook: Key Biomarkers of Immunomodulation ― Complement Factors and Cytokines Poster: Parallelism Challenges When Using Commercial Kits for Biomarker Quantitation |
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Scientific Journal: Issue 23 — Robust Sample Management for Reliable Study Results Unboxing Video: What’s Inside Altasciences’ Clinical Sample Collection Kit? Blog: Q&A with Dr. Nicole Maciolek — Setting Up Your Clinical Research for Success |
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