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SD5015

By Rosa Grant,2014-08-04 13:31
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SD5015

    Formatting of Bioequivalence Summary Tables

1. Please provide these tables as pdf files and in MSWord. Place the MSWord format of all the tables in

    Module 2.7 and the pdf files in the appropriate eCTD/CTD locations. 2. Margins for the paper should be 1” for the top and bottom and 1.25” for the left and right sides.

    3. All text should be Times New Roman 10.

    4. Please use the Default Table Style when creating the tables when they are created in Microsoft? Word.

    (Select Menu Table-Table Auto Format-Table Normal)

    5. Table 1, Table 4, Table 7, Table 8, and Tables 10-16 should be in PORTRAIT orientation. 6. Table 2, Table 3, Table 5, Table 6, Table 9 should be in LANDSCAPE orientation.

    ;Table 1 Submission Summary

     Drug Product Name

     Strength(s)

     Applicant Name

     Address

     Point of Contact

     Name

     Address

     Telephone Number

     Fax Number

Or, please provide an electronic copy of Form 356H.

    Table 2 Summary of Bioavailability Studies

    Subjects Mean Parameters (+/-SD) Treatments (No. (M/F) Study Study Study (Dose, Dosage Study Design Type Report Cmax Tmax AUC0-t AUC? T? Kel Ref. No. Objective Form, Route) Age: mean Location (units/mL) (hr) (units) (units) (hr) (hr-1) [Product ID] (Range)

    Test product

    strength

    Tab./Cap./Susp # completing Median p.o. M M (#M/#F) M (%CV) (Range) M (%CV) M (%CV) Randomized [Batch #] (%CV) (%CV) Fasting study Healthy subjects Study # single-dose Vol.# p.# title or patients crossover Ref. product M M mean age M (%CV) Median M (%CV) M (%CV) strength (%CV) (%CV) (range) (Range) Tab./Cap./Susp

    p.o.

    [Batch #]

    Test product

    strength

    Tab./Cap./Susp # completing p.o. M M (#M/#F) M (%CV) Median M (%CV) M (%CV) Randomized [Batch #] (%CV) (%CV) Fed study Healthy subjects (Range) Study # single-dose Vol.# p.# title or patients crossover Ref. product M M mean age M (%CV) Median M (%CV) M (%CV) strength (%CV). (%CV) (range) (Range) Tab./Cap./Susp

    p.o.

    [Batch #]

Table 3 Statistical Summary of the Comparative Bioavailability Data

    Drug

    Dose (# x mg)

    Least Squares Geometric Means, Ratio of Means, and 90% Confidence Intervals

    Fasted Bioequivalence Study (Study No.)

    Parameter Test Reference Ratio 90% C.I.

     AUC0-t

     AUC?

     Cmax

    Fed Bioequivalence Study (Study No.)

    Parameter Test Reference Ratio 90% C.I.

     AUC0-t

     AUC?

     Cmax

Table 4 Bioanalytical Method Validation

    Information Requested Data

    Provide the volume(s) and page(s) Bioanalytical method validation report

    location

    Provide the name(s) of the analyte(s) Analyte

    Identify the internal standard used Internal standard (IS)

    Brief description of extraction method; analytical method Method description

    LOQ, units Limit of quantitation

    % Average recovery of drug (%)

    % Average recovery of IS (%)

    Standard curve range and appropriate concentration units Standard curve concentrations (units/mL)

    List all the concentrations used QC concentrations (units/mL)

    Range or per QC QC Intraday precision range (%)

    Range or per QC QC Intraday accuracy range (%)

    Range or per QC QC Interday precision range (%)

    Range or per QC QC Interday accuracy range (%)

    hours @ room temperature Bench-top stability (hrs)

    days @ 4ºC Stock stability (days)

     hours @ room temperature; hours @ 4ºC