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Stability Software

The leading laboratory for solving complex stability and formulation challenges using world-class science to speed products to market.

Why use FreeThink’s ASAPprime® Stability Software

FreeThink’s ASAPprime® software, based on the Accelerated Stability Assessment Program, enables scientists to quickly and accurately determine product shelf life. A range of scientifically and statistically designed exposure conditions are used to force a product to fail (hit its stability specification limits). Using these edge-of-failure times (isoconversion times) at a range of conditions allows the software to project the long-term storage shelf life based on short-term data.

ASAPprime® is now widely used in the pharmaceutical and other industries to speed up many aspects of product development, to make better decisions faster, and in some cases, to meet regulatory requirements.

To learn more about ASAPprime® and schedule a demonstration, please contact us.

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Stability Software

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Stability Software

ASAPdesign™

ASAPprime®

Regulatory

Services

Stability Software

ASAPdesign™

ASAPprime®

Regulatory

Services

ASAPdesign™

ASAPdesign™ is a subroutine within ASAPprime® that designs an optimal study for data modeling. ASAPdesign™ first considers the precision of the measurements needed to determine the failure point and thereby establishes the number of repeats needed to power the study. From the number of analyses used and how long the study will last, the program populates an optimized design with respect to repeats, conditions (temperature, relative humidity), and timepoints. The design space is limited based on any phase boundaries. To hit the product’s specification limit at as many conditions as possible, available prior knowledge (or default behavior) is used to establish appropriate conditions and timepoints.

When an ASAPprime® study is carried out in shorter overall times, there is a greater extrapolation to the long-term conditions with correspondingly larger error bars.

When the design requires relative humidity control, ASAPdesign™ provides information about the appropriate saturated salts to use at each condition. These studies are carried out in individual jars containing vials of salt slurries to control the relative humidity in “mini chambers.”

Click here to watch a video demonstration of ASAPdesign™.

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ASAPprime®

When the degradation behavior of a product is not linear, fitting of the data to temperature models can be non-predictive. With ASAPprime®, data are analyzed using different curve shapes to determine isoconversion times (tiso). The isoconversion times at all conditions are fit to the moisture modified or standard Arrhenius equation, which has been shown to work across all chemical and most physical changes that occur as samples age. The probability that a product will remain within its specification limits at the end of its shelf life is calculated using Monte Carlo simulations.

Ideal packaging is determined by combining calculated relative humidity as a function of time inside a package with the moisture sensitivity of the product from the ASAPprime® fitting. The relative humidity versus time behavior is calculated using the balance of moisture transfer rates and the ability of the product to hold moisture as a function of relative humidity. ASAPprime® uses an extensive database of both packaging material moisture permeabilities (bottles, blisters, and drums) and moisture sorption isotherms of most pharmaceutical materials.

Click to view: “What is ASAPprime®?”

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Regulatory

ASAPprime® is used in conjunction with, or as a replacement for, traditional ICH or accelerated stability studies. There have been over 100 successful regulatory filings for drug products (RX, OTC) using ASAPprime®, including NDAs globally. While in clinical applications ASAPprime® alone has been successfully used in place of traditional data, for NDAs and post-approval changes ASAPprime® modeling is first validated against any ICH data available (either for an earlier lot prior to a change or using available data on the product itself at the point of filing). ASAPprime® can then be used to show that the stability does not vary with the change (ASAPprime® bridges stability before and after a process, formulation, or raw material change) or that a longer shelf life can be assigned than justified from the long-term data itself.

To learn more about how ASAPprime® has been used in regulatory submissions:

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Services

Training

FreeThink provides complimentary training for new customers who license ASAPprime®. This covers practical lessons for carrying out experiments, hands-on work with the software, and theoretical background (science and statistics). The course is taught by a FreeThink authorized trainer and can be completed on-site or virtually. Customers who complete the training will receive a certificate. FreeThink also provides options for subsequent refresher and advanced training.

Consulting

FreeThink offers consulting services for software customers needing assistance with designing, analyzing, or interpreting their ASAP studies. We also help prepare regulatory documentation for clinical, market, and post-approval applications using ASAPprime®. We have extensive experience in the use of ASAPprime® with most health authorities.

IQ/OQ

ASAPprime® customers can purchase onsite Installation Qualification and Operational Qualification (IQ/OQ) services. These qualification services are useful when using ASAPprime® in regulatory filings. An authorized FreeThink representative works with your IT and/or technical staff to install ASAPprime® under a pre-approved protocol and carries out extensive tests to demonstrate the validated software was delivered as specified (IQ) and will function according to operational specifications (OQ). Documentation is provided following a successful IQ/OQ.

ASAPprime®GO!™

The ASAPprime®GO!™ Study Starter Kit is used as a tool to ensure proper running of an ASAP laboratory and use of the software for analysis and to establish Performance Qualification (PQ). Each kit includes:

  • Specially designed active tablets for stressing
  • Saturated salts with vials having prepared lids (24 count)
  • Analytical method and standards
  • Labels for glassware
  • Detailed instructions for carrying out work and using ASAPprime® for modeling
  • Expected results to verify against
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FAQs

Q: Can ASAPprime® be used in regulatory filings?

A: Yes, ASAPprime® has been successfully used in regulatory filings worldwide. It supports applications during clinical phases, drug approvals, and post-approval changes. 

Have more questions? Contact our team to discuss your needs [here].

Q: How does licensing work?

A: ASAPprime® is licensed annually, with discounted multi-year options available. The first year includes free training. Qualification options (IQ/OQ) are also available, and FreeThink offers the ASAPprime®GO! kit for process qualification.

Interested in licensing options? Contact us [here].

Q: Can I use ASAPprime® with my traditional stability data?

A: Traditional stability studies often lack the detail needed for ASAP modeling, as ICH stability programs typically involve limited temperature points and poorly controlled humidity exposure. Instead, we use any available long-term data to validate the ASAPprime® modeling, especially in regulatory filings.

Contact us to learn how ASAPprime® enhances traditional stability studies. [here].

Q: Does ASAPprime® help manage or calculate trending for traditional stability studies?

A: No, ASAPprime® does not include functions for managing traditional stability studies. It is also not suitable for data analysis or trending from such studies.

Have specific questions? Contact our team [here].

Q: Is it better to license ASAPprime® or to outsource the ASAP study to FreeThink?

A: Licensing ASAPprime® allows large, well-staffed companies to manage studies internally. Smaller organizations, requiring only one to two studies annually, may find outsourcing more practical. Some companies choose to do both.

Need help deciding? Contact us to explore your options [here].

Q: How is data security handled with ASAPprime®?

A: ASAPprime® is not web-based. All data reside within the company licensing the software, stored on individual computers or shared storage systems. Companies can implement their own security measures to ensure data safety.

Have more concerns about data security? Learn more [here].

Q: Is ASAPprime® a Laboratory Information Management System (LIMS)?

A: No, ASAPprime® does not track samples. It is designed to analyze accelerated, not traditional, stability data.

Contact us for further clarification [here].

Q: What are the technical requirements to install and run ASAPprime®?

A: ASAPprime® requires Microsoft Windows 7 SP1 or a newer operating system and 450 MB of available hard disk space.
Need help with installation? Reach out to our support team [here].