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ASAPprime®
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
ASAPprime® is a software package available from FreeThink Technologies, Inc. The software is based on the Accelerated stability assessment program (ASAP) and uses experimental data modelling to accurately determine the shelf-life of products in very short time periods.
ASAPprime®
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
Use the ASAPdesign™ Wizard
to create an experimental
plan foran ASAP study for
your specificproduct.
ASAPprime®
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
Each plan is based on product knowledge, designspace limitations of temperature and relativehumidity (RH), data precision required, time available,and the number of samples chosen to be analysed.
ASAPprime®
This plan is based on product knowledge,
design space limitations of temperature
and relative humidity (RH), dataprecision
required, time available, and the number
of samples chosen to beanalyzed.
The experimental design
produces conditions and time
points to which your product is
exposed, without package
protection, designed to make
the product hit, but not greatly
exceed, its specification limit.
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
ASAPprime®
This plan is based on product knowledge,
design space limitations of temperature
and relative humidity (RH), dataprecision
required, time available, and the number
of samples chosen to beanalyzed.
Design tools include an Analysis
Scheduler to schedule when each
sample should be added and
removed from chambers, and a
randomized order for analysis to
minimize any systematic error
due to instrument drift or other
causes.
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
ASAPprime®
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
Chromatography
Conduct your ASAP study in a matter of weeks.
Mini-chamber holds your product sample, saturated salt solution vial for RH control, and datalogger
Digital convection ovens
ASAPprime®
design space limitations
and relative humidity(RH
required, time available,
of samples chosento
This plan is based on product knowledge,
Design tools include anAnalysis of temperature
Scheduler, and the ability to randomize ), dataprecision
order for analysis, whichis especially and the number
important duringcomparison studies be analyzed.
(e.g., formulation screening).
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
The study results are input into the main program to build a mathematical model of the product behaviour.
ASAPprime®
design space limitations
and relative humidity(RH
required, time available,
of samples chosento
This plan is based on product knowledge,
Design tools include anAnalysis of temperature
Scheduler, and the ability to randomize ), dataprecision
order for analysis, whichis especially and the number
important duringcomparison studies be analyzed.
(e.g., formulation screening).
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
.Design tools include an Analysis Scheduler, and the ability to randomize order for analysis, which is especially important during comparison studies (e.g., formulation screening).Data are analyzed in terms of isoconversion times (times when the product fails) at each condition. In this paradigm, the conversion to degradation products is kept constant to target the specification limit, while time is varied at each condition. When degradation amounts at a particular condition are close to the specification limit, the estimation of the isoconversion time will have a small error bar. When extrapolation is needed, the precision will be lower.
ASAPprime®
design space limitations
and relative humidity(RH
required, time available,
of samples chosento
This plan is based on product knowledge,
Design tools include anAnalysis of temperature
Scheduler, and the ability to randomize ), dataprecision
order for analysis, whichis especially and the number
important duringcomparison studies be analyzed.
(e.g., formulation screening).
Add your product formulation (API and
excipients), choose from a database of
packages (bottles, blisters, drums, and custom
packaging), and model behavior of your
product under long-term storage conditions.
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
ASAPprime®
design space limitations
and relative humidity(RH
required, time available,
of samples chosento
This plan is based on product knowledge,
Design tools include anAnalysis of temperature
Scheduler, and the ability to randomize ), dataprecision
order for analysis, whichis especially and the number
important duringcomparison studies be analyzed.
(e.g., formulation screening).
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
ASAPprime® enables you to look at many “what if”
scenarios. For example, you can adjust the initial
water content of your product, predict what would
happen if there was a shipping excursion, or
consider the impactof changing climate zones.
ASAPprime®
ASAP is different than traditionalstability:
➢ ASAP incorporates a open temperature
and RH conditions to make the product
fail, then calculates the packaging
required to pass at long- term storage
conditions
➢ ASAPdoes not assume product behavior
is linear over the long-term
➢ ASAP is Fast and Accurate!
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com
ASAPprime®
Regulatory acceptance:
➢ ASAP is used in conjunction with, or as a
replacementfor,
➢ traditional ICH or accelerated stability studies
➢ ASAP has been successfully used in place of
traditional stability, in support of use-period
assignments for INDs for many country authorities
including the USAFDA
➢ ASAPhas been used to justify late-stage minor
changes as part of NDA filings, and post-approval
changes of products that would normally require
new stabilityprograms
➢ With generics, ASAPjustifies equivalence to the
originator
Copyright FreeThink Technologies, Inc. 2019
freethinktech.com