DOC

SD5015

By Rosa Grant,2014-08-04 13:31
11 views 0
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 Processed stability (hrs)

    # cycles Freeze-thaw stability (cycles)

    17 days @ -20ºC (or other) Long-term storage stability (days)

    Concentration diluted X-fold Dilution integrity

    No interfering peaks noted in blank plasma samples Selectivity

Please include table for each analyte.

    Please submit all Method Validation SOPs.

    Table 5 Summary of In Vitro Dissolution Studies

     Dissolution Conditions Apparatus:

     Speed of Rotation:

     Medium:

     Volume:

     Temperature:

     Firm’s Proposed Specifications

     Dissolution Testing Site

    (Name, Address)

    Study Testing Product ID \ Batch No. Dosage No. of Collection Times (minutes or hours) Study Ref No. Date (Test - Manufacture Date) Strength Dosage Report (Reference Expiration Date) & Form Units Location Study Test Product mg 12 Mean Report Tablet Range #: Capsule %CV Study Reference Product mg 12 Mean Report Tablet Range #: Capsule %CV

    Provide dissolution data for all strengths (test and reference).

Table 6 Formulation Data

    Ingredient Amount (mg) / Tablet Amount (%) / Tablet

    Strength 1 Strength 2 Strength 1 Strength 2 Cores

Coating

    Total 100.00 100.0

Please include the formulation of all strengths.

Table 7 Demographic Profile of Subjects Completing the Bioequivalence Study

    Study No.

     Treatment Groups

    Test Product Reference Product

    N = N = Age Mean ? SD 50 ? 15 (years) Range 21 - 64 Age < 18 N(%) N(%) Groups 18 40 N(%) N(%)

    40 64 N(%) N(%)

    65 75 N(%) N(%)

    > 75 N(%) N(%) Sex Male N(%) N(%)

    Female N(%) N(%) Race Asian N(%) N(%)

    Black N(%) N(%)

    Caucasian N(%) N(%)

    Hispanic N(%) N(%)

    Other N(%) N(%) BMI Mean ? SD

    Range Other Factors

Please provide a separate table for each Bioequivalence Study

Table 8 Incidence of Adverse Events in Individual Studies

    Reported Incidence by Treatment Groups Body System / Fasted/Fed Bioequivalence Study Adverse Event Study No.

    Test Reference Body as a whole

     Dizziness N (%) N (%)

     Etc. N (%) N (%) Cardiovascular

     Hypotension

     Etc. Gastrointestinal

     Constipation

     Etc. Other organ sys.

    Total N (%) N (%)

Provide separate table for each Bioequivalence Study

Table 9 Reanalysis of Study Samples

    Study No.

    Additional information in Volume(s), Page(s)

    Number of samples reanalyzed Number of recalculated values used after reanalysis Reason why assay was repeated Actual number % of total assays Actual number % of total assays

    T R T R T R T R 1Pharmacokinetic Reason A (e.g. below LOQ) Reason B Reason C Etc. Total 1 - If no repeats were performed for pharmacokinetic reasons, insert “0.0.”

Please provide a separate table for each analyte measured for each in-vivo study.

Table 10 Study Information

     Study Number

     Study Title

     Clinical Site

    (Name, Address, Phone #)

     Principal Investigator

     Dosing Dates

     Analytical Site

    (Name, Address, Phone #)

     Analysis Dates

     Analytical Director

     Storage Period of Biostudy

    Samples

    (no. of days from the first day of sample collection to the last day of sample analysis)

Please provide separate table for each Bioequivalence Study

Report this document

For any questions or suggestions please email
cust-service@docsford.com