AAPS stability comparability discussion topic - brief survey

Below is a short survey to determine interest on topics related to product stability comparability so as to facilitate discussion and enable knowledge exchange at our next quarterly AAPS meeting on Sept 7

Question Title

* 1. Indicate which of the following molecules you have experience conducting comparability studies of pre-change and post-change lots

Small molecules

Biologics

ADC

Question Title

* 2. Per the study design at your company pre-change and post-change lots are (select all that apply)

Stored together

Tested together

Neither

Question Title

* 3. How do you evaluate potential differences in product quality between pre-change and post-change lots?

Question Title

* 4. Do you use pre-determined criteria to compare pre-change and post-change lots?

Yes

Sometimes

Question Title

* 5. How do you evaluate differences in product quality between pre-change and post-change lots? (select all that apply)

Pre-determined criteria

Visual evaluation

Other

Question Title

* 6. The pre-determined criteria in your studies include: (select all that apply)

Quantitative

Qualitative

Statistical

Question Title

* 7. Provided below are a list of possible topics that we may focus on at the next meeting. Please rank numbers (1,2,3,4) based on your level of interest (start with most interested)
1. Statistical methods for establishing criteria including details on pre-change lots used to establish the criteria
2. Establishing Pre-determined statistical criteria – is it a requirement?
3. Content to include in regulatory filing such as trend plots
4. Study design such as storage and testing conditions, number of lots

AAPS stability comparability discussion topic - brief survey

Question Title

* 1. Indicate which of the following molecules you have experience conducting comparability studies of pre-change and post-change lots

Question Title

* 2. Per the study design at your company pre-change and post-change lots are (select all that apply)

Question Title

* 3. How do you evaluate potential differences in product quality between pre-change and post-change lots?

Question Title

* 4. Do you use pre-determined criteria to compare pre-change and post-change lots?

Question Title

* 5. How do you evaluate differences in product quality between pre-change and post-change lots? (select all that apply)

Question Title

* 6. The pre-determined criteria in your studies include: (select all that apply)

Question Title

Question Title

* 8. Please indicate any other topics of interest related to stability comparability that are not listed above.