This document provides guidance on formatting tables for a bioequivalence submission. It includes templates for 21 tables requiring information on bioavailability and bioequivalence studies, analytical methods, subject demographics, pharmacokinetic results and other data. The tables are to be provided in PDF and Word format, with most in landscape orientation and following specific formatting guidelines.
This document provides guidance on formatting tables for a bioequivalence submission. It includes templates for 21 tables requiring information on bioavailability and bioequivalence studies, analytical methods, subject demographics, pharmacokinetic results and other data. The tables are to be provided in PDF and Word format, with most in landscape orientation and following specific formatting guidelines.
This document provides guidance on formatting tables for a bioequivalence submission. It includes templates for 21 tables requiring information on bioavailability and bioequivalence studies, analytical methods, subject demographics, pharmacokinetic results and other data. The tables are to be provided in PDF and Word format, with most in landscape orientation and following specific formatting guidelines.
This document provides guidance on formatting tables for a bioequivalence submission. It includes templates for 21 tables requiring information on bioavailability and bioequivalence studies, analytical methods, subject demographics, pharmacokinetic results and other data. The tables are to be provided in PDF and Word format, with most in landscape orientation and following specific formatting guidelines.
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Formatting of Bioequivalence Summary Tables
1. 2. #. *. ". 3. 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. Mar ins for the paper should be 1! for the top and bottom and 1.2"! for the left and ri ht sides. $ll te%t should be Times &e' (oman 1). Please use the Default Table St+le 'hen creatin the tables 'hen the+ are created in Microsoft, Word. -Select Menu Table.Table $uto /ormat.Table &ormal0 Table 11 Table *1 Table 71 Table 21 and Tables 1).13 should be in P4(T($5T orientation. Table 21 Table #1 Table "1 Table 31 Table 6 should be in 7$&DSC$P8 orientation.
Table 1 Submission Summary
Drug Product Name Strength(s) !!licant Name ddress Point of "ontact Name ddress Tele!hone Number Fa# Number 4r1 please provide an electronic cop+ of /orm #"39.
This information is needed for a complete ;ioe<uivalence revie' and1 althou h re<uired for the archival cop+ submitted to the $ enc+1 it is fre<uentl+ not readil+ available in the ;ioe<uivalence Submission. The Division of ;ioe<uivalence prefers that this information be submitted as a electronic /orm #"39. 5f this is not possible1 then please complete Table 1.
(andomi>ed /astin stud+ sin le.dose title crossover
= completin -=M/=/0 9ealth+ subAects or patients mean a e -ran e0
M -BCC0 M -BCC0
Median M M -(an e0 M -BCC0 M -BCC0 -BCC0 -BCC0 Col.= p.= M M Median M -BCC0 M -BCC0 -BCC0 -BCC0 -(an e0
Stud+ =
/ed stud+ title
(andomi>ed sin le.dose crossover
= completin -=M/=/0 9ealth+ subAects or patients mean a e -ran e0
M -BCC0 M -BCC0
M M Median M -BCC0 M -BCC0 -BCC0 -BCC0 -(an e0 M M Median M -BCC0 M -BCC0 -BCC0. -BCC0 -(an e0
Col.= p.=
Table 8 Statistical Summary of the "om!arative Bioavailability Data
Drug Dose (9 # mg) 2east Squares :eometric -eans) %atio of -eans) and ;4< "onfidence +ntervals Fasted Bioequivalence Study (Study No&) Test %eference %atio
Parameter 3"41t 3"5 "ma# Parameter 3"41t 3"5 "ma#
;4< "&+&
Test
Fed Bioequivalence Study (Study No&) %eference
%atio
;4< "&+&
Table = Bioanalytical -ethod >alidation
+nformation %equested Bioanalytical method validation re!ort location nalyte +nternal standard (+S) -ethod descri!tion 2imit of quantitation verage recovery of drug (<) verage recovery of +S (<) Standard curve concentrations (units.m2) ?" concentrations (units.m2) ?" +ntraday !recision range (<) ?" +ntraday accuracy range (<) ?" +nterday !recision range (<) ?" +nterday accuracy range (<) Bench1to! stability (hrs) Stoc@ stability (days) Processed stability (hrs) FreeAe1thaB stability (cycles) 2ong1term storage stability (days) Dilution integrity Selectivity Please include table for each anal+te. Please submit all Method Calidation S4Ps. Data Provide the volume-s0 and pa e-s0 Provide the name-s0 of the anal+te-s0 5dentif+ the internal standard used ;rief description of e%traction methodD anal+tical method 74E1 units B B Standard curve ran e and appropriate concentration units 7ist all the concentrations used (an e or per EC (an e or per EC (an e or per EC (an e or per EC hours F room temperature da+s F *GC hours F room temperatureD hours F *GC = c+cles 17 da+s F .2)GC -or other0 Concentration diluted H.fold &o interferin peaIs noted in blanI plasma samples
Table C Summary of +n >itro Dissolution Studies
Dissolution "onditions !!aratus/ S!eed of %otation/ -edium/ >olume/ Tem!erature/
FirmDs Pro!osed S!ecifications Dissolution Testing Site (Name) ddress) Study %ef No& Stud+ (eport =J Stud+ (eport =J Testing Date Product +D E Batch No& (Test 1 -anufacture Date) (%eference F G#!iration Date) Test Product Dosage Strength H Form m Tablet Capsule m Tablet Capsule No& of Dosage 3nits 12 "ollection Times (minutes or hours) Study %e!ort 2ocation
(eference Product
12
Mean (an e BCC Mean (an e BCC
Provide dissolution data for all stren ths -test and reference0.
Table I Formulation Data
+ngredient "ores mount (mg) . Tablet Strength 1 Strength $ mount (<) . Tablet Strength 1 Strength $
"oating
Total Please include the formulation of all stren ths.
144&44
144&4
Table J Demogra!hic Profile of Sub(ects "om!leting the Bioequivalence Study
Study No& Treatment :rou!s Test Product %eference Product NK NK ") K 1" 21 . 3* &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0
$ e -+ears0 $ e Lroups
Se% (ace
;M5 4ther /actors
Mean K SD (an e M 12 12 N *) *) N 3* 3" N 7" O 7" Male /emale $sian ;lacI Caucasian 9ispanic 4ther Mean K SD (an e
Please provide a separate table for each ;ioe<uivalence Stud+
Table L +ncidence of dverse Gvents in +ndividual Studies
Body System . dverse Gvent ;od+ as a 'hole Di>>iness 8tc. Cardiovascular 9+potension 8tc. Lastrointestinal Constipation 8tc. 4ther or an s+s. %e!orted +ncidence by Treatment :rou!s Fasted.Fed Bioequivalence Study Study No& Test %eference & -B0 & -B0 & -B0 & -B0
Total
& -B0
& -B0
Provide separate table for each ;ioe<uivalence Stud+
Table ; %eanalysis of Study Sam!les
Study No& dditional information in >olume(s)) Page(s) Number of sam!les reanalyAed Number of recalculated values used after reanalysis ctual number < of total assays ctual number < of total assays T % T % T % T %
%eason Bhy assay Bas re!eated
PharmacoIinetic1 (eason $ -e. . belo' 74E0 (eason ; (eason C 8tc. Total 1 . 5f no repeats 'ere performed for pharmacoIinetic reasons1 insert P).).! Please provide a separate table for each anal+te measured for each in.vivo stud+.
Table 14 Study +nformation
Study Number Study Title "linical Site (Name) ddress) Phone 9) Princi!al +nvestigator Dosing Dates nalytical Site (Name) ddress) Phone 9) nalysis Dates nalytical Director Storage Period of Biostudy Sam!les (no& of days from the first day of sam!le collection to the last day of sam!le analysis) Please provide separate table for each ;ioe<uivalence Stud+
Table 11 Product +nformation
Product Treatment +D Product Name -anufacturer Batch.2ot No& -anufacture Date G#!iration Date Strength Dosage Form Bio1batch SiAe Production Batch SiAe Potency "ontent 3niformity (mean) <">) Dose dministered %oute of dministration Test %eference
&/$ &/$
&/$ &/$ &/$
Table 1$ Dro!out +nformation
Sub(ect No Study No& %eason for dro!out.re!lacementM Period %e!lacedN %e!laced Bith
Please provide separate table for each ;ioe<uivalence Stud+ Q Please provide time1 treatment -test or reference01 and cause of dropout1 if reason of dropout is other than Ppersonal reasons!.
Table 18 Protocol Deviations
Study No& Ty!e Sub(ect 9s (Test) Sub(ect 9s (%ef&)
Please provide a separate table for each ;ioe<uivalence Stud+
Table 1= Summary of Standard "urve and ?" Data for Bioequivalence Sam!le nalyses Bioequivalence Study No& nalyte Name Standard "urve Sam!les
Parameter Concentration -n 1 mc /m70 5nter da+ Precision -BCC0 5nter da+ $ccurac+ -B$ctual0 7inearit+ 7inearit+ (an e -n 1 mc /m70 Sensitivit+/74E -n 1 mc /m70
Bioequivalence Study No& nalyte Name ?uality "ontrol Sam!les
5f applicable1 please provide separate tables for the parent dru and metabolite-s0
Table 1C S'PDs Dealing Bith Bioanalytical %e!eats of Study Sam!lesM
S'P No& Gffective Date of S'P S'P Title
Q Please include the S4P for ;ioanal+tical (epeats in +our submission.
Table 1I "om!osition of -eal 3sed in Fed Bioequivalence Study
"om!osition /at Carboh+drate Protein Total "om!osition of -eal 3sed in Fed Bioequivalence Study Percent of total 7cal 7cal
5f the standard meal referenced in the CD8( Luidance for 5ndustr+ /ood.8ffect ;ioavailabilit+ and /ed ;ioe<uivalence Studies is used1 then it is not necessar+ to complete the table. 5n that case1 please add a statement in the fed bioe<uivalence stud+ report indicated that the P/D$ standard meal! 'as used. 5f an alternative meal is used1 then please complete the above summar+ table.
