Join Dr. Anahita Keyhani for a discussion on proactive, effective, and efficient bioanalytical project management, and the positive impact it can have on your drug development program.
 
Topics covered include:

• The framework for successful bioanalytical support at various phases and for different types of studies
• Bioanalytical critical control points (operational, logistical, technical, and scientific) to proactively manage for successful project progression
• Bioanalytical communication flow and key stakeholders for different types of studies

Watch the webinar

You may also be interested in the following:

• Fact Sheet: Clinical Sample Kits
• Webpages: Bioanalytical Services
• Webinar: Critical Sample Handling Processes for Preclinical and Clinical 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.

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.

Choosing the Right Partner for Your Formulation Needs

Altasciences’ extensive formulation and manufacturing services, integrated with our early phase drug development offering, spans across the full drug development pathway, from discovery through commercialization. Our scientists have decades of expertise with both simple and complex dosage forms, and a successful track record of formulating molecules and developing the drug products required to support early phase clinical trials.
 
Discover our full range of analytical services, including: 

• Drug product release and stability testing
• Method development, qualification, and validation 
• On-site, ICH stability storage and testing

Get a head start on your project ― speak with one of our scientists.
 
You may also be interested in the following:

• Webpage: Pharmaceutical Contract Manufacturing Services
• Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials
• Webpage: 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.

The thorough and precise evaluation of cardiac effects is a critical element of new chemical entity development. You can choose to add early cardiac safety assessment to your first-in-human studies, or wait and perform a Thorough QT prolongation study; either way, we can help you with the study design and conduct.

In this educational video, Dr. Beatrice Setnik, Altasciences’ Chief Scientific Officer, walks you through the differences between early and late QT prolongation testing.

Watch the video.

Speak with our experts today for help in deciding between early and late QT prolongation testing.  

You may also be interested in the following: 

• Webpage: QT Assessment
• Fact Sheets:
  • Safety Pharmacology
  • Cardiac Assessment 
  • First-in-Human
• The Altascientist: Cardiac Clinical Trials, Global Regulatory Requirements, Design, and Timing of QT Assessment (Case Study Included)

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.

Regulated bioanalytical development for the analysis of antisense oligonucleotides (ASOs) is showing promise in therapeutic applications for a number of diseases.  

From preclinical to clinical, Altasciences has significant expertise in supporting robust and sensitive bioanalytical assays that minimize interference, for accurate quantification of ASOs in complex biological tissues.

In the last couple of years, our bioanalytical scientific experts have developed close to 100 assays of various matrices, supported close to 100 preclinical and clinical studies at various stages, and analyzed over 15,000 samples in oligonucleotide quantitation.

Speak with an expert today to ensure you are provided with the best bioanalytical techniques for your ASO drug development program.

Speak with an expert today

You may also be interested in the following:

• The Altascientist: Antisense Oligonucleotides
• Webinars:
  • Assessing Cognition and Driving Ability in Clinical Pharmacology Studies
  • Quantitation of Passive Immunotherapeutic Agents for COVID-19 by LC-MS
• Webpages:
  • Preclinical Solutions
  • Clinical 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.

Investigating the Abuse Potential of your CNS-Active Therapeutic

The FDA Guidance, Assessment of Abuse Potential of Drugs, states: 

Drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential…

The results of a human abuse potential (HAP) trial can indicate that your product will need an abuse-deterrent formulation (ADF), or specific labelling. Altasciences’ scientific, regulatory, and clinical experts will work with you to design a roadmap for your HAP evaluation program. 

HAP trials are procedurally intense, requiring high levels of skill and experience, secure clinical facilities with the necessary licenses, and pharmacy capabilities and expertise to ensure appropriate handling and storage of the drug products. 

For a more in-depth look at the requirements and implications of HAP trials for your drug development program, consult The Altascientist — Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs.

Speak with an expert today for more information or to review your specific program requirements.


Related Resources:

Webinar: To Control or be Controlled – Navigating the Abuse Potential Evaluation of CNS-Active Drugs for EU and US Submissions

Scientific Poster: Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse, Dependence, and Impairing Effects of CNS-Active Drugs in Healthy Volunteer and Patient Trials

Webpage: Human Abuse Potential


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.