Where to start?
For many teams AQbD = DoE
And that’s exactly why it feels overwhelming, abstract and a whole bunch of ‘extra’ experiments outside of your day-to-day lab work.
Here’s the part that often gets missed:
- AQbD isn’t a new regulatory burden that arrived with ICH Q14
- And no, AQbD is 𝘯𝘰𝘵 just DoE.
In fact, AQbD doesn’t even start with experiments.
Before you touch a dissolution tester, you ask one question: What must this method reliably and consistently achieve?
That answer becomes your ATP i.e., 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝗧𝗮𝗿𝗴𝗲𝘁 𝗣𝗿𝗼𝗳𝗶𝗹𝗲
From there you ‘𝗚𝗮𝘁𝗵𝗲𝗿 𝗽𝗿𝗶𝗼𝗿 𝗸𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲’ by collecting relevant information on solubility/ stability, formulation and manufacturing.
This helps you focus on what actually matters: the 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗠𝗲𝘁𝗵𝗼𝗱 𝗔𝘁𝘁𝗿𝗶𝗯𝘂𝘁𝗲𝘀 (𝗖𝗠𝗔𝘀) e.g., % drug dissolved at a specified time point and the method parameters that impact the CMAs – these are your 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗠𝗲𝘁𝗵𝗼𝗱 𝗣𝗮𝗿𝗮𝗺𝗲𝘁𝗲𝗿𝘀 (𝗖𝗠𝗣𝘀) e.g., paddle speed, medium pH
Only then does 𝗗𝗲𝘀𝗶𝗴𝗻 𝗼𝗳 𝗘𝘅𝗽𝗲𝗿𝗶𝗺𝗲𝗻𝘁𝘀 (𝗗𝗼𝗘) come in- not as ‘extra lab work’ but as systematic experiments to understand which parameters truly affect method performance.
That understanding defines your 𝗠𝗢𝗗𝗥 - 𝗠𝗲𝘁𝗵𝗼𝗱 𝗢𝗽𝗲𝗿𝗮𝗯𝗹𝗲 𝗗𝗲𝘀𝗶𝗴𝗻 𝗥𝗲𝗴𝗶𝗼𝗻:
A proven ‘safe’ zone, a range/ combination of method parameters where the method consistently meets the ATP.
And importantly, this design space offers 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘧𝘭𝘦𝘹𝘪𝘣𝘪𝘭𝘪𝘵𝘺 - minor adjustments within the MODR don’t automatically trigger revalidation.
With the method parameters locked in, the dissolution method must be ‘𝗱𝗶𝘀𝗰𝗿𝗶𝗺𝗶𝗻𝗮𝘁𝗼𝗿𝘆’ enough to distinguish between batches that affect in vivo behavior.
And the most critical step of all? 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁 everything! Maintain a structured record for every step.
So, as you can see, AQbD doesn’t make dissolution method development more complex.
Nor is it a new regulatory burden that arrived with ICH Q14
It’s what good scientists were already doing - only now it has a name, structure and ICH credentials.
Read also: Difference Between QbD and AQbD
Resource Person: Pearl Pereira Nambiar
