LINEARITY (ICH vs ANVISA)

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  • čas přidán 13. 09. 2024

Komentáře • 15

  • @rahulkulkarni3037
    @rahulkulkarni3037 Před 2 lety +1

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

  • @PRAVEENKUMAR-xb6sb
    @PRAVEENKUMAR-xb6sb Před 2 lety +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 Před měsícem

    What about recovery 3 preparation or single

  • @AkshayRajHendre54
    @AkshayRajHendre54 Před rokem

    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?

  • @krish_krish354
    @krish_krish354 Před 2 lety

    Any limit for residuals and bias at 100% and homoscedticity

  • @JayPatel-kr3ip
    @JayPatel-kr3ip Před 2 lety

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

    • @pharmagrowthhub3083
      @pharmagrowthhub3083  Před 2 lety +1

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

    • @JayPatel-kr3ip
      @JayPatel-kr3ip Před 2 lety

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

  • @sushmagupta2787
    @sushmagupta2787 Před 2 lety

    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  Před 2 lety

      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 Před 2 lety

      Can you say the guidelines reference no for intercept nmt 2

  • @krish_krish354
    @krish_krish354 Před 2 lety

    Sensitivity should be high any criteria

  • @krish_krish354
    @krish_krish354 Před 2 lety

    Make video for 5 % significance level

  • @vishalgagare3783
    @vishalgagare3783 Před 2 lety

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