LINEARITY (ICH vs ANVISA)

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  • Опубликовано: 1 янв 2025

Комментарии • 17

  • @rahulkulkarni3037
    @rahulkulkarni3037 2 года назад +1

    Most of the people are not aware about ANVISA guideline about Linearity.Thank you for teaching us beautifully.

  • @krish_krish354
    @krish_krish354 5 месяцев назад

    What about recovery 3 preparation or single

  • @PRAVEENKUMAR-xb6sb
    @PRAVEENKUMAR-xb6sb 2 года назад +1

    Wonderful presentation 👏
    Sir I want to know ANOVA (analysis of variance) how to calculate this and how to interpretation of this statistical data, Sometimes ANVISA asking for this also
    And put some light on t-95 upper and t 95 lower. I have some confusion regarding this.
    Thank you.

  • @krish_krish354
    @krish_krish354 2 года назад

    Any limit for residuals and bias at 100% and homoscedticity

  • @sushmagupta2787
    @sushmagupta2787 2 года назад

    As per FDA regulations if intercept more than 2 then linearity shall not be accepted.
    Please make clarity, if is there situation like this
    How to resolve

    • @pharmagrowthhub3083
      @pharmagrowthhub3083  2 года назад

      You may narrow down the range, in case of not meeting acceptance criteria. High background noise (for instrument methods) and residuals may lead to high bias.

    • @krish_krish354
      @krish_krish354 2 года назад

      Can you say the guidelines reference no for intercept nmt 2

  • @JayPatel-kr3ip
    @JayPatel-kr3ip 2 года назад

    Please prepare a video on all calculation parameters like the residual sum of squares.

    • @pharmagrowthhub3083
      @pharmagrowthhub3083  2 года назад +1

      Hello Jay. Please find a video on the calculation of the residual sum of squares for your kind information. Link: ruclips.net/video/vhVBolLIC5Y/видео.html

    • @JayPatel-kr3ip
      @JayPatel-kr3ip 2 года назад

      @@pharmagrowthhub3083 Thank you for reply. I am talking about ANVISA calculation parameter such as homoscedasticity, angular coefficient, and 5% significance level in full calculation.

  • @AkshayRajHendre54
    @AkshayRajHendre54 Год назад

    According to ANVISA, "The solutions used for the evaluation of linearity must be prepared independently and diluted solutions from the SAME MOTHER SOLUTION of the CRS can be used."
    Where they says three different stock solutions must be prepare?

  • @mamatapanthi6987
    @mamatapanthi6987 18 дней назад

    Sir One class is needed for excel for this calculationa.In maximum cases regulatory body excels are locked.So calculation formula for excel highly needed

  • @krish_krish354
    @krish_krish354 2 года назад

    Sensitivity should be high any criteria

  • @vishalgagare3783
    @vishalgagare3783 2 года назад

    Hi Sir please tell me limit of %Y intercept why is +-10%

  • @krish_krish354
    @krish_krish354 2 года назад

    Make video for 5 % significance level