Choose Wisely.

With decades of experience developing and manufacturing almost every dosage form on the market, our experts can guide you in selecting the optimal one for your drug development program.

Read the infographic to discover the pros and cons of the two most popular solid oral dosage forms to determine which is best for your molecule.

Ready to discuss your drug development and manufacturing needs? Send us a message.

Related resources that may interest you:

• Webpage: Drug Development, Manufacturing, and Analytical Testing Services
• Podcast: Key Considerations When Formulating APIs for Preclinical Testing
• eBook: Applications of Liquid-Filled Hard-Shell Capsules in Pharmaceutical Development

Unique FIH Solutions
for Small and Large Molecules

Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. Our FIH solution provides a customized approach that is safe, and delivers quality data with speed and ease.

This eBook provides an overview of how our unique process can facilitate your early-phase clinical program:

    •   small molecule manufacturing experts quickly formulate your drug product and deliver it to the clinical site, ready for dosing;
    •   coordinated processes between our clinic and our bioanalytical labs;
    •   timed interim sample analysis for proactive dose escalation decisions and rapid turnaround of PK/PD analysis between cohorts;
    •   transparent communication between our teams and locations, and strict attention to early-phase timelines; and
    •   a database of over 400,000 normal healthy volunteers and strict safety protocols.

Access the eBook here to learn more.

Speak with one of our experts.

You may also be interested in the following:

Webpages:

    •   Phase I Clinical Trial Units
    •   First-in-Human Trial Capabilities

Scientific Journal:

    •   The Advantages of Conducting Early Phase Clinical Research in Canada

CNS Center of Excellence Resource Library

Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.

Here are some of our most insightful scientific resources in the area of CNS drug development:

Webinar: A Square Peg in a Round Hole–Navigating the Unique Attributes of Psychedelic Drug Development
Altasciences’ panel of experts discuss the FDA’s recently published guidelines for early-phase clinical development of psychedelics and the assessment of abuse potential. Watch Now

The Altascientist: Central Nervous System
Early-phase development of CNS-acting drugs is a complex, challenging undertaking.
In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development. Learn More

The Altascientist: CNS, Psychedelics, and Other Schedule I Drugs
In this scientific journal, we uncover the regulatory environment and challenges, the required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs, and the manufacturing considerations for CNS-active drugs. Learn More

The Altascientist: Studying the Effects of Drugs on Driving
Driving simulation studies are required by the FDA when preclinical and early clinical studies show that a drug may cause somnolence or impair cognition. Discover the challenges of driving simulation clinical testing. Learn More

The Altascientist: Human Abuse Potential Studies
The 2017 FDA guidance states that a broad range of CNS drugs require human abuse potential (HAP) studies to evaluate the abuse liability of drugs in development before a drug reaches the market. The complicated regulatory pathway for HAP requires individualized consulting for each type of study. Watch Now

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

Have five more minutes? Check out these webpages:
      •   CNS Clinical Trials
      •   Human Abuse Potential<
      •   Driving Simulation<

Decoding FDA Requirements

Watch as Altasciences’ panel of experts discuss the FDA’s recently published guidelines for early-phase clinical development of psychedelics and the assessment of abuse potential.

Topics covered:
      •   important FDA recommendations;
      •   clinical methods to optimize early-phase clinical trials with psychedelics;
      •   how to address the abuse potential evaluation requirement for psychedelic drugs; and
      •   strategies to ensure study integrity.

You may also be interested in the following resources:
      •   Webpage: CNS Drug Development Solutions
      •   Scientific Journal: Challenges Associated with Schedule I Therapeutic Development
      •   Webinar: Practical Approaches to Conducting Early Clinical Trials with Psychedelics

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Optimizing Drug Development With Biomarkers

The strategic integration of biomarkers into the drug development process empowers sponsors with critical information at every stage.

Altasciences’ biomarker services provide insight into a drug’s efficacy, safety, and mechanism of action, where we can translate findings into clinical applications and beyond, resulting in reduced timelines.

Our Laboratory Sciences team has the scientific, operational, and regulatory acumen to offer pre-existing validated assays in multiple species and matrices, and can develop new methods to meet your needs.

Is the assay you are looking for missing? Contact us to discuss how we can support your specific needs.

You may also be interested in the below resources:

Fact Sheets

•   Flow Cytometry Services
•   Immunogenicity Testing
•   Immunomodulatory Drugs

eBooks

•   Key Biomarkers of Immunomodulation
•   Altasciences' Proactive Drug Development Solution: Large Molecules

Poster Presentation

•   Immunogenicity Target Interference: A Novel Blocking Approach

Start Your Driving Trial Quickly—Simulators On-Site

Driving simulator studies are a safe, efficient, and effective alternative to on-the-road driving trials for CNS-active drugs. This issue of The Altascientist dives into the requirements and technicalities of driving studies, and explains how driving simulation offers:

Faster study startup • Lower cost • No risk of property damage • No risk of injuries

This issue includes a case study for which the results were described as “reassuring” by the FDA.

Altasciences has conducted over 13,000 simulated drives in support of drug development.

Download as a PDF or listen to the audiobook; the choice is yours.

You may also be interested in the following: 
     •   Driving Studies Webpage
     •   Driving Studies Webinar