CMC Statistics Community

 View Only
Back to discussions
Expand all | Collapse all

Discover The Stats Snax Series

  • 1.  Discover The Stats Snax Series

    Community Leadership
    Posted 09-22-2022 12:00
    Have you discovered Stats Snax?

    Stats Snax discusses basic statistical concepts that apply to the pharmaceutical industry using examples from CMC development areas. Designed for non-statisticians, you will learn foundational concepts that CMC statisticians encounter in their daily interactions with clients.

    #StatsSnax #CMCStatistics ​​​

    ------------------------------
    Stacey Axler
    Community Manager
    AAPS
    Arlington VA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------


  • 2.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 09-22-2022 12:01
    How is a p-value calculated? Find out in the #StatsSnax series! Stats Snax discusses statistical concepts that apply to the #pharmaceutical industry using examples from #CMC development areas.



    ------------------------------
    Stacey Axler
    Community Manager
    AAPS
    Arlington VA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 3.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 09-27-2022 16:31
    What is a Confidence Interval? Find out in the #StatsSnax series! Stats Snax discusses statistical concepts that apply to the #pharmaceutical industry using examples from #CMC development areas.


    ------------------------------
    Jonathan Ross
    Associate Director MSAT Upstream Drug Substance
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 4.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 10-11-2022 16:32
    Understanding statistical measures of model fit is important to understand the quality of the model fit. Two values, R2 and R2 adjusted are common statistical measures used to evaluate model fit. R2 also known as the coefficient of determination and R2 adjusted are mathematically calculated using sums of squares. Having the ability to interpret these values strengthens the scientists' understanding of a statistical model and improves their skills to create better models. The goal of this video is to explain what R2 and R2 adjusted are and understand the meaning.


    ------------------------------
    Jonathan Ross
    Associate Director MSAT Upstream Drug Substance
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 5.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 10-12-2022 09:57
    Very useful simple video Jonathan. 

    It would be nice to extend by one more slide to discuss where R-square adjusted is more useful than R-Square.  

    I have not seen any life sciences scientist that never used R-square but not sure how often they use R-Square adjusted.


    You or anyone in the group can give some practical examples for the utility of R-Square in R&D.  

    Thanks for taking time to post the video.
    -Raja  



    Original Message


  • 6.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 10-31-2022 12:18
    Hi Raja, 

    Thanks for the suggestions. From my experience as a life sciences scientist, I've seen R-square utilized frequently for model selection even though it is not the best tool. As seen on slide 8, R-squared and R-Squared adjusted can be misleading. I would suggest looking at R-Squared adjusted for information purposes only, but understand that although the number may be high, it may not be telling the entire story of the data. 

    -Jonathan

    ------------------------------
    Jonathan Ross
    Associate Director MSAT Upstream Drug Substance
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 7.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 10-31-2022 12:07
    This Stats Snack will focus on the concepts of statistical significance and practical importance and will compare/contrast the two. Statistical significance is grounded in statistical testing. Practical importance interprets the results of statistical testing in the context of scientific importance. Videos on "what is a p-value?" and "What is a confidence interval?" should be viewed before this video for ease of understanding.


    ------------------------------
    Jonathan Ross
    Associate Director MSAT Upstream Drug Substance
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 8.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 11-04-2022 11:59
    This presentation will focus on the conceptual difference between statistical process control and statistical quality control. SPC is the application of statistical techniques and/or statistical or stochastic control algorithms to analyze leading indicators. SQC is the application of various statistical methodologies to monitor lagging indicators such as process output and all product quality attributes. Although SPC and SQC utilize similar statistical tools; distinct differences in the objectives exist between the two applications as discussed by the International Standards Organization (ISO, 11462-1:2009).


    ------------------------------
    Jonathan Ross
    Associate Director MSAT Upstream Drug Substance
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 9.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 11-04-2022 13:29
    This presentation will focus on the use of equivalence testing as opposed to difference testing for the demonstration of mean comparability for two processes. Although both approaches are performed by constructing a confidence interval on the average difference, the hypotheses being testing are quite different. The presentation will demonstrate these differences through an application used to determine if the accuracy of two analytical procedures can be considered comparable. Presentations on "what is a p-value?" and "What is a confidence interval?" should be viewed before this video for ease of understanding.


    ------------------------------
    Jonathan Ross
    Associate Director MSAT Upstream Drug Substance
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 10.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 11-17-2022 18:52
    This presentation will focus on how to select the appropriate regression model for multiple stability lots to determine or extend expiry per the fixed lot paradigm prescribed in ICH Q1E. The presentation on " Determining Expiry using Regression" should be viewed before this for ease of understanding.


    ------------------------------
    Jonathan Ross
    Associate Director MSAT Upstream Drug Substance
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 11.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 11-18-2022 11:54
    Jonathan, 
    The RS Community is rebuilding with other communities help...Can you suggest a CMC statistics member that will be interested in joining our monthly meetings to provide input on regulatory aspects of CMC statistics? 
    -Raja Velagapudi
    Chair, RS Community




    Original Message


  • 12.  RE: Discover The Stats Snax Series

    Posted 11-18-2022 15:17
    Hi Raja-

    We have a goal to partner with other communities to elevate CMC Statistics collaborations, so we would be happy to help.  I will send you request to our community members and have interested folks reach out to you.

    Thanks so much,
    LP
    Past Chair, CMC Stats Community

    ------------------------------
    Laura Pack
    Sr. Director, Quality Control & Statistics
    Rezolute Inc
    Loveland CO
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 13.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 11-18-2022 20:26
    Thank you Laura,  highly appreciated. CMC statistics has an important role in complex product development, establishing simarity.  Also,  in in- vitro release similarity.   We like to have at least one member to join our meetings in these areas to provide programing to understand regulatory aspects. Our focus is regulatory application and suitability of tests to be used in these situations. 
    Thanks again for your collaboration. 
    - Raja Velagapudi 





    Original Message


  • 14.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 12-13-2022 14:09
    Hi Raja,

    I am the new Chair of the CMC Statistics Community.
    Dr. Stan Altan ([email protected]) has volunteered to act as our liaison with the Regulatory Community for 2023. Please feel free to connect with him and share your thoughts for collaboration between the two communities.

    Thanks,
    Janet Alvarado
    Director, Center for Mathematical Sciences
    Merck (Manufacturing Division)

    ------------------------------
    Janet Alvarado
    Director
    Merck & Co Inc
    West Point PA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 15.  RE: Discover The Stats Snax Series

    Community Leadership
    Posted 11-18-2022 10:52

    This presentation will focus on Interpreting Regression on Stability Data with Respect to ICH Q1E. It will show how to graphically determine expiry based on a regression line and 95% confidence bound(s). The presentation titled “What is a confidence interval?” can be viewed before this video but is not required for understanding.


    ------------------------------
    Jonathan Ross
    Associate Director MSAT Upstream Drug Substance
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message