Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples

 Hi friends,

  Here shared a topic "Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples  Retained Under 21 CFR 320.38(c) Guidance for Industry by USFDA August 2020" .For details click on below link:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-quantity-bioavailability-and-bioequivalence-samples-retained-under-21-cfr-32038c

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Bioanalytical Method Validation

Bioanalytical method validation parameters

Hi,

     Friends here i try to explain the bioanalytical method validation parameters as per the guideline for easy understanding.

Selectivity

Selectivity has the ability to differntiate the bioanalytical method and measure the analyte in the presence of potential Interfering substance in the biological matrix.Perform selectivity exercise with 6 indivial sources/lots of biological matrix in plain, haemolyed and lipemic.

Selectivity perform for both analyte and internal standard.

Selectivity exercise perform using blank samples (matrix samples processed without addition of an analyte or IS).The results of Selectivity Should be,no significant response contribute to interfering components is observed at the retention time(s) of the analyte or the IS in the blank samples. If Responses detected and attributable to interfering components should not be more than 20% of the analyte response at the LLOQ sample and not more than 5% of the IS response in the LLOQ sample for each matrix.

Specificity

Specificity is the ability of a bioanalytical method to detect and differentiate the analyte from other substances, including its related substances (e.g., substances that are structurally similar to the analyte, metabolites, isomer, impurities, degradation products formed during sample preparation, or concomitant medications that are expected to be used in the treatment of patients with the intended indication.

Note:

concomitant medications are like paracetamol, caffine, cetrizine, diclofenac, Ibuprofen etc.If concomitant medications drugs are used during study then selectivity for that particular drugs has to performed.

If concomitant medications are given during study then impact of such substances should be evaluated during method validation or alternatively in the pre-dose study samples.

In the case of LC-MS based methods, to assess the impact of such substances, the evaluation may include comparing the molecular weight of a potential interfering related substance with the analyte and chromatographic separation of the related substance from the analyte. Responses detected and attributable to interfering components should not be more than 20% of the analyte response at the LLOQ and not more than 5% of the IS response in the LLOQ sample.The possibility of back-conversion of a metabolite into the parent analyte during the successive steps of the analysis (including extraction procedures or in the MS source) should also be evaluated when relevant (i.e., potentially unstable metabolites such as ester analytes to ester/acidic metabolites, unstable N-oxides or glucuronide metabolites, lactone-ring structures).It is acknowledged that this evaluation will not be possible in the early stages of drug development of a new chemical entity when the metabolism is not yet evaluated.

For Bioanalytical Draft Advisory Document of the Working Group on Good Laboratory Practice on GLP Data Integrity Aug 2020

 Hello friends,

                     Found a Draft Advisory Document of the Working Group on Good Laboratory                                    Practice on GLP Data Integrity Aug 2020 for bioanalytical peoples for reading                              click on link

       

  http://www.oecd.org/env/ehs/testing/DRAFT_OECD_Advisory_Document_on_GLP_Data_Integrity_07_August_2020.pdf

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      htttps://www.bioanalyticalscience.com 

Bioanalytical Method Development

         

          Method Development

• The purpose of bioanalytical method development is to define the chromatographic conditions, limitations and suitability of the method for its intended purpose and to confirm that the method is optimised for validation. 
• Before the development of a bioanalytical method, analyst should understand the analyte of interest (e.g., the physicochemical properties of the drug, in vitro and in vivo metabolism and protein binding).
• Method development involves optimising the procedures and conditions involved with sample extracting and detecting the analyte. Method development can include the optimisation of the following bioanalytical parameters to ensure that the method is suitable for validation: Reference standards, Specific reagents, Calibration curve standards (CC), Quality control samples (QCs), Selectivity and specificity, sensitivity, accuracy, precision, recovery, stability of analyte in matrix and dilution preparation.
• Once the method has been developed, bioanalytical method validation confirm that method is suitable for study sample analysis.

M10 BIOANALYTICAL METHOD VALIDATION FDA

 

           Hello friends,

            Found an bioanalytical method validation guideline 

            may be interested in:

        https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation

      Regards,

      htttps://www.bioanalyticalscience.com