ASAPprime® Licenses & Training

ASAPprime® Licenses

ASAPprime® is the industry standard for pharmaceutical accelerated stability modeling and is currently licensed by the majority of large pharmaceutical companies.

User data are isolated since the program is installed and runs locally on customer PCs. Active licensees receive all updates and bug fixes at no additional charge.

Licensing options can be configured for your needs and include the following:

  • 1-year: one seat, one site
  • Multi-year and/or multi-user
  • Global license

System requirements for the ASAPprime® software include the following:

  • Microsoft Windows 7 or later
  • Total memory on designated computer is at least 4 GB
  • Free disk space available is at least 450 MB

With a license, you:

  • have unlimited use of ASAPprime® for the user
  • gain access to the FreeThink help desk and ASAPprime® user manual
  • receive document validation
  • join the family of ASAPprime® users!

Optional add-ons include:

  • ASAP training course (see below)
  • Installation Qualification/Operational Qualification (IQ/OQ) (read more)
  • ASAPprime® GO!™ Study Starter Kit (read more)
  • Regulatory support (read more)

ASAPprime® Basic Training

FreeThink offers customers the option to purchase a 7-hour training course on all aspects of ASAPprime®, including both practical lessons for carrying out experiments, hands-on work on the software and theoretical background (science and statistics). The course is taught by a FreeThink authorized trainer with options for conducting the course at either a FreeThink-authorized facility, on-site at a company, or by a web-based system.

The user will receive a certificate indicating the successful completion of ASAPprime® Basic Training.

The training syllabus is as follows:

I. Experimental Design
  • Setting up an ASAP study
  • Using the ASAPdesign™ module
II. Input Data
  • Input of data into ASAPprime®
  • User options
  • Data precision
III. Isoconversion
  • Kinetics
  • Why use isoconversion?
  • Data evaluation
  • Isoconversion precision
  • Summary
IV. Temperature
  • Background
  • The Arrhenius Equation
  • Statistics of temperature extrapolation
  • Summary
V. Moisture
  • Background
  • Moisture terminology
  • Combining RH and T
  • Conclusions
VI. Low Conversion
VII. Packaging
  • Background
  • Permeability
  • Bottles
  • Blisters
  • User entered MVTR values
  • Desiccant
  • User entered GAB
  • Parameters
  • Headspace moisture
  • Moisture accounting
  • Initial RH / water %
  • Conclusions
VIII. Potency
  • Background
  • Release specifications vs. stability specifications
  • Potency statistics
  • Standard deviation
  • Conclusions
IX. Excursions, In-use Stability, Results Comparison
X. Physical
  • Immediate release tablet dissolution
  • Capsule dissolution
  • Color change
  • Viscosity
  • Amorphous drug form
  • Accelerated stability not applicable for ASAP
XI. Regulatory
  • Overview
  • Pre-clinical
  • Early clinical trials (IND)
  • API, reference standards
  • ASAP and QbD
  • ASAP in NDA (sNDA) submissions
  • ASAP in ANDA submissions
  • Post-approval change

ASAPprime® Advanced Training

For knowledgeable users of ASAPprime®, FreeThink also offers advanced training. This training is more customized, based on the customer’s needs, and can use real data (under a confidentiality agreement).

The advanced training can serve as a “refresher” for the user(s), it can be utilized as companies gain more experience with ASAPprime®, and it can also assist in expanding the depth and range of users.

The user will receive a certificate indicating the successful completion of ASAPprime® Advanced Training.

Would you like to learn more?

For more information, or to get a price quote, please contact us.