Document ID: FDA-2007-D-0369-0002
Agency: fda
Document Type: Notice
Title: Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
Posted Date: 2007-10-25T04:00Z

<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">
<HTML>
<HEAD>
<META name="generator" content="PDFCreactiveX HTML Export">
<META name="creation-date" content="07/04/2008 07:10:05 ">
<TITLE></TITLE>
<SCRIPT LANGUAGE="JavaScript1.2"> var agt=navigator.userAgent.toLowerCase();if ( (parseInt(navigator.appVersion)>=4) &&(agt.indexOf('mozilla')!=-1) && (agt.indexOf('spoofer')==-1)&& (agt.indexOf('compatible') == -1) ){msie = false;} else if ( (parseInt(navigator.appVersion)>=4) &&(agt.indexOf('msie') != -1) ) {msie = true;	} page=0;</SCRIPT>
</HEAD>
<BODY bgcolor="#ffffff" text="#000000" topmargin=0 leftmargin=0 marginheight=0 marginwidth=0 >
<SPAN STYLE="color:#000000;position:absolute;left:385.90pt;top:25.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.80pt;top:54.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.80pt;top:89.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.55pt;top:119.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:84.85pt;top:120.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:398.50pt;top:83.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:101.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:445.30pt;top:101.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:398.75pt;top:109.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:117.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.80pt;top:155.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.55pt;top:181.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.85pt;top:217.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:88.90pt;top:215.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.60pt;top:245.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:84.00pt;top:242.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.60pt;top:301.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.90pt;top:299.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.85pt;top:325.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.20pt;top:350.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.95pt;top:376.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.85pt;top:401.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.00pt;top:427.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.80pt;top:453.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.05pt;top:479.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.55pt;top:505.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.80pt;top:530.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.75pt;top:560.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:78.70pt;top:558.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.30pt;top:583.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.05pt;top:609.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.05pt;top:635.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:34.80pt;top:665.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.75pt;top:663.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:34.55pt;top:688.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:34.30pt;top:713.85pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:791.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:271.45pt;top:817.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.15pt;top:844.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.40pt;top:870.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.15pt;top:896.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.90pt;top:921.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.90pt;top:946.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.65pt;top:973.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:241.45pt;top:973.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.90pt;top:1001.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:211.30pt;top:999.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.95pt;top:1025.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.90pt;top:1057.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.65pt;top:1055.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.45pt;top:1080.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.70pt;top:1106.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.20pt;top:1139.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.95pt;top:1167.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:49.55pt;top:1167.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.25pt;top:1194.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.70pt;top:1220.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.50pt;top:1246.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.50pt;top:1272.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.50pt;top:1298.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.50pt;top:1324.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:208.20pt;top:1323.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.20pt;top:1349.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.95pt;top:1375.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.20pt;top:1400.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:62.15pt;top:1429.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.00pt;top:1454.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.00pt;top:1479.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.65pt;top:1505.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:207.50pt;top:1504.85pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:1582.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:272.30pt;top:1612.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.50pt;top:1638.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.30pt;top:1664.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.30pt;top:1690.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.50pt;top:1715.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.00pt;top:1741.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.30pt;top:1767.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.55pt;top:1802.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.85pt;top:1803.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:297.70pt;top:1804.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:333.35pt;top:1803.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:39.00pt;top:1828.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.55pt;top:1856.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:83.40pt;top:1854.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.55pt;top:1878.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.30pt;top:1904.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.10pt;top:1929.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.60pt;top:1954.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.10pt;top:1989.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:52.70pt;top:1989.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.55pt;top:2016.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:59.05pt;top:2016.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.15pt;top:2015.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.60pt;top:2039.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.35pt;top:2064.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.35pt;top:2090.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.35pt;top:2115.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.35pt;top:2139.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:62.90pt;top:2164.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:62.90pt;top:2189.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:62.90pt;top:2214.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.60pt;top:2250.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:51.70pt;top:2250.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:294.70pt;top:2251.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:330.35pt;top:2250.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:35.55pt;top:2275.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:62.40pt;top:2299.70pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:2374.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:272.50pt;top:2402.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.90pt;top:2427.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.75pt;top:2454.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.40pt;top:2483.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.40pt;top:2511.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.75pt;top:2538.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.90pt;top:2567.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.50pt;top:2593.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:241.55pt;top:2595.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.30pt;top:2618.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.30pt;top:2647.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.05pt;top:2675.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:111.00pt;top:2673.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.80pt;top:2699.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.05pt;top:2725.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:38.10pt;top:2751.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.85pt;top:2778.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.55pt;top:2804.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:468.85pt;top:2806.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:479.50pt;top:2804.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.55pt;top:2830.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.10pt;top:2832.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:74.40pt;top:2830.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.10pt;top:2854.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:62.90pt;top:2883.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.30pt;top:2909.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:380.40pt;top:2910.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:37.30pt;top:2937.00pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3166.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:43.50pt;top:3221.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:117.65pt;top:3217.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:144.90pt;top:3219.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:151.70pt;top:3217.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:85.60pt;top:3242.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:43.50pt;top:3308.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:43.25pt;top:3320.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:43.50pt;top:3345.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:229.60pt;top:3347.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:256.00pt;top:3346.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:43.00pt;top:3376.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:106.10pt;top:3505.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:109.60pt;top:3515.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:156.90pt;top:3514.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:180.40pt;top:3515.55pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3958.00pt"> </SPAN>
</BODY>
</HTML>