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			<div id="newshow-title">【原创】基于BCS分类的豁免相关指导原则的对比</div>
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				  <h1 id="activity-name" class="rich_media_title " style="font-size:22px;font-family:system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-weight:400;color:;font-style:normal;background-color:#ffffff;text-indent:0px;" align="center">
	【原创】基于BCS分类的豁免相关指导原则的对比
</h1>
<strong><span style="color:#ffffff;">一</span></strong> 
<h1 style="font-size:16px;font-weight:400;text-align:justify;">
	<strong><span style="color:#e36c09;">一、&nbsp;</span></strong><strong><span style="color:#e36c09;">BCS的定义</span></strong>
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<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS：biopharmaceutics classification sysetm，国内一般译作生物药剂学分类系统，是根据药物在<strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#007aaa;">水中的溶解度</span></strong>和<strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#007aaa;">肠壁渗透能力</span></strong>对药物进行科学分类的标准。对于口服固体速释制剂而言，原料药的溶解性、渗透性和制剂的溶出度这3 个方面基本决定了药物在体内的吸收速度和程度。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">根据FDA指导原则的定义，原料药按照BCS 可分为以下几类：</span>
</p>
<ul class="list-paddingleft-1" style="font-size:17px;font-family:system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-weight:400;color:;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<li>
		<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS Ⅰ：高溶解性-高渗透性；</span>
	</li>
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		<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS Ⅱ：低溶解性-高渗透类；</span>
	</li>
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		<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS Ⅲ：高溶解性-低渗透性；</span>
	</li>
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		<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS Ⅳ：低溶解性-低渗透性。</span>
	</li>
</ul>
<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"><br />
</span><strong><span style="color:#ffffff;">二</span></strong> 
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	<strong><span style="color:#e36c09;">二 、&nbsp;</span></strong><strong><span style="color:#e36c09;">什么是基于BCS的生物等效性豁免</span></strong>
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<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">制剂之间的治疗等效性一般需要进行体内生物等效性研究来论证，但是如果体外研究能够充分证明体内性能无差异，那么可以豁免此项研究。对于特定剂型，在符合某一标准时，BCS 可以作为申请人和监管机构评判是否可以豁免生物等效性研究的工具，</span>
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">这就是基于BCS 的生物等效性豁免的定义。</span>
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">目前出台的相关指导原则如下：</span>
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
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<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">WHO 2006年发布：</span></strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">Technical Report Series No.937，其中Annex 7和Annex 8引入基于BCS的生物等效性豁免。</span>
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">EMEA 2010发布：</span></strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">Note for guidance on the Investigation on Bioavailability and Bioequivalence。</span>
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">FDA 2017年12月发布：</span></strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">生物等效性BE豁免指导原则，Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Guidance for Industry。</span>
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">食品药品监督管理局2016年5月8日发布：</span></strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">2016年第87号通告附件 人体生物等效性试验豁免指导原则。</span>
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">CDE：</span></strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">ICH《M9：基于生物药剂学分类系统的生物等效性豁免》。CDE在2018年9月5日与2020年05月26日均发布了相关的征求意见稿，并于2021年12月31日正式发布关于ICH Q5D、M9及M9问答实施建议公开征求意见的通知，要求申请人需在现行技术要求基础上，尽早按照ICH指导原则的要求开展研究；本公告发布之日起6个月后开始的相关研究（以试验记录时间点为准），适用上述ICH指导原则。</span>
</p>
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	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">以下将从这几个指导原则进行对比分析：</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"><br />
</span><strong><span style="color:#ffffff;">三</span></strong>
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	<strong><span style="color:#e36c09;">&nbsp;三、</span></strong><strong><span style="color:#e36c09;">豁免范围、剂型与辅料要求</span></strong>
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<table style="font-size:17px;font-family:system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;width:677px;border-collapse:collapse;font-weight:400;color:;font-style:normal;text-align:justify;margin:0px 0px 10px;background-color:#ffffff;" cellspacing="0">
	<tbody>
		<tr>
			<td style="background:#f1f1f1;" valign="middle" width="56">
				<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"><strong>指导原则</strong></span>
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			<td style="background:#f1f1f1;" valign="middle" width="86">
				<p style="text-align:justify;">
					<strong><span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">豁免范围</span></strong>
				</p>
			</td>
			<td style="background:#f1f1f1;" valign="middle" width="190">
				<p style="text-align:justify;">
					<strong><span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">剂型要求</span></strong>
				</p>
			</td>
			<td style="background:#f1f1f1;" valign="middle" width="254">
				<p style="text-align:justify;">
					<strong><span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">辅料要求</span></strong>
				</p>
			</td>
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				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">FDA</span>
				</p>
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			<td valign="middle" width="86">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS I类</span>
				</p>
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			<td valign="middle" width="190">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">适用剂型为口服固体速释制剂，不包括口腔内吸收的剂型，如含片和舌下片</span>
				</p>
			</td>
			<td valign="middle" width="254">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">通常，使用经FDA 批准的用于口服固体速释制剂的辅料，不会引起BCS，类药物的吸收问题。但是，如果处方中使用了新辅料或者辅料用量超过常量许多时，应论证辅料不会影响药物的生物利用度。某些辅料用量较大时，如表面活性剂( 如聚山梨酯-80) 和甜味剂(如甘露醇、山梨醇) ，可能会引发问题，应与审评人员沟通</span>
				</p>
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				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">EMA</span>
				</p>
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				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS I、III类</span>
				</p>
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			<td valign="middle" width="190">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">适用剂型为口服固体速释制剂; 必须为发挥全身治疗作用的制剂; 对于口腔分散片或口腔崩解片，应排除口腔吸收; 适用于速释型复方制剂，条件是复方中的所有活性成分都属于BCS 分类Ⅰ或Ⅲ，并且辅料符合章节IV．2 的要求</span>
				</p>
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				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS Ⅰ原料药的制剂，建议试验制剂使用与对照制剂用量相近的相同辅料</span>
				</p>
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS Ⅲ原料药的制剂，为了排除对膜转运体影响的不同，应采用与对照制剂定性相同定量相似的辅料。</span>
				</p>
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">对于可能影响到生物利用度的辅料(如山梨醇、甘露醇、十二烷基硫酸钠或其他表面活性剂) ，应了解其对胃肠蠕动、与药物的相互作用、渗透性、与膜转运体之间的相互作用，并在试验制剂和对照制剂中应具定性和定量的等同性</span>
				</p>
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				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">WHO</span>
				</p>
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			<td valign="middle" width="86">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS I、II、III类</span>
				</p>
			</td>
			<td valign="middle" width="190">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">适用剂型为口服固体速释制剂; 复方制剂按“最差条件”进行试验，例如阿莫西林和克拉维酸。克拉维酸属于BCS Ⅲ类，阿莫西林属于BCS Ⅰ类，那么复方制剂就应按BCS Ⅲ类要求进行试验</span>
				</p>
			</td>
			<td valign="middle" width="234">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">在辅料种类方面，仿制药辅料与对照药一致，或者与已在ICH 成员国上市的同品种仿制药一致。在辅料用量方面，仿制药辅料含量应与对照药相近，或者是该类剂型的常规用量</span>
				</p>
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">对于符合豁免条件的含BCS Ⅲ类活性成分的仿制药，一般情况下，当药物的吸收程度较低( 特别是当Fabs ＜50%) 时，如果吸收部位局限于胃肠道近端和/或吸收过程服从诱导/竞争机制时，需要对辅料的定性和定量组成作详细评估（偏离对照药越多，作出不适当的豁免决定的风险就越大）</span>
				</p>
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">对于符合豁免条件的含BCSⅡ类活性成分的仿制药，应对处方中所用表面活性剂的类型和用量进行严格的评估</span>
				</p>
			</td>
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				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">ICH&nbsp;M9</span>
				</p>
			</td>
			<td valign="middle" width="86">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS I、III类</span>
				</p>
			</td>
			<td valign="middle" width="190">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">适用于将药物输送至体循环的普通口服固体速释剂型或混悬剂。具有窄治疗窗的药物制剂不适用本指导原则中基于BCS的生物等效性豁免。对于固定剂量复方(FDC)制剂，若所有药物活性成份均符合本指导原则第2和第3章节中的标准,则适用基于BCS的生物等效性豁免。</span>
				</p>
			</td>
			<td valign="middle" width="254">
				<p style="text-align:justify;">
					<span style="font-size:12px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">理想情况下,受试制剂的组成应模仿参比制剂。但是,若辅料存在差异，应评价这些差异可能对体内吸收产生的影响。</span>
				</p>
			</td>
		</tr>
	</tbody>
</table>
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	<br />
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<strong><span style="color:#ffffff;">四</span></strong> 
<h1 style="font-size:16px;font-weight:400;text-align:justify;">
	<strong><span style="color:#e36c09;">&nbsp;四、</span></strong><strong><span style="color:#e36c09;">体外研究的要求*</span></strong>
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	<br />
<img alt="" src="http://sxyykj.com/upfile/image/20230818/20230818092094489448.png" />
</p>
<strong><span style="color:#ffffff;">五
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	<img alt="" src="http://sxyykj.com/upfile/image/20230818/202308180920003030.png" /></span></strong>
</p>
<h1 style="font-size:16px;font-weight:400;text-align:justify;">
	<strong><span style="color:#e36c09;">&nbsp;五、</span></strong><strong><span style="color:#e36c09;">关于基于BCS 的生物等效性豁免的适用标准</span></strong>
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<p>
	<span style="font-size:15px;"><strong><span style="color:#e36c09;">1）FDA</span></strong></span><br />
<br />
<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">① 不属于治疗指数窄的药物。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">② 制剂为口服固体速释制剂，不包括口腔内吸收的药物，如含片和舌下片。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">③ 原料药属于BCS Ⅰ类。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">④ 制剂能够快速溶出，即该制剂在3 种不同pH 的溶出介质中（pH1.2，pH4.5和pH6.8标准溶出介质），以桨法（50rpm）或篮法（100rpm）（体积≤900 mL），在30min 内的溶出量≥85%。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">⑤ 辅料应使用FDA 批准的用于口服固体速释制剂的辅料。如含有新辅料或原辅料用量超常多时，应论证辅料不影响药物的生物利用度。某些辅料用量过大时，如表面活性剂（如聚山梨酯-80）和甜味剂（如甘露醇、山梨醇）可能会引发问题，需与审评人员沟通。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;"><strong><span style="color:#e36c09;">2）WHO</span></strong></span><br />
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<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">① 制剂为口服固体速释制剂。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">② 原料药可以为BCSⅠ、Ⅱ和Ⅲ类，但对应的制剂溶出度要求不同；</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">原料药为BCS Ⅰ类：制剂符合快速溶出的要求，即在pH1.2，pH4.5和pH6.8的标准溶出介质中，以桨法（75rpm）或篮法（100rpm）（温度37℃，体积≤900 mL），在30 min 内的溶出量≥85%。试验制剂与对照制剂的溶出曲线比较，f2&gt;50。若试验制剂与对照制剂在上述溶出条件下，15 min内的溶出量≥85%，可认为是极快速溶出制剂，不再需要比较溶出曲线。</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">原料药为BCS Ⅲ类: 若试验制剂与对照制剂都是极快速溶出的制剂，即在pH1.2，pH4.5和pH6.8的标准溶出介质中，以桨法（75rpm）或篮法（100rpm）（体积≤900 mL），在15 min 内的溶出量≥85%。这种情况下，可以考虑豁免生物等效性研究。一般情况下，在进行资料审评（比如特定部位吸收、吸收部位的抑制/竞争、辅料以及治疗风险）时，对BCS Ⅲ类原料药的制剂做出豁免生物等效性研究结论的错误风险高于BCSⅠ类。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<img alt="" src="http://sxyykj.com/upfile/image/20230818/20230818092281368136.jpg" /><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>
</p>
<p style="font-size:17px;font-family:system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-weight:400;color:;font-style:normal;text-align:center;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">原料药在pH6.8溶液中具有较高溶解性但在pH1.2或pH4.5溶液中溶解性差的制剂( BCSⅡ中的弱酸性化合物) 。BCS Ⅱ中有一些弱酸性化合物原料药同时符合以下条件时，可以考虑豁免生物等效性研究：</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">（<span>i</span>）在pH6.8溶液中具有较高溶解性，即单次给药的最大剂量能溶解在≤250 mL pH6.8缓冲液中。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">（<span>i<span>i</span></span>）制剂应符合pH6.8条件下的快速溶出，即在pH6.8的标准溶出介质中，以桨法（75rpm) 或篮法(100 rpm) (体积≤900 mL) ，在30 min 内的溶出量≥85%。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">（<span>i<span>i<span>i</span></span></span>）在pH1.2，pH4.5和pH6.8的标准溶出介质下，试验制剂与对照制剂的溶出曲线比较，f2＞50。对于此类仿制药，应对处方中所用的表面活性剂辅料的类型和用量进行严格的评价。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">&nbsp;&nbsp;&nbsp; </span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">③&nbsp;辅料不应导致试验制剂与对照制剂在吸收方面的差异（如对胃肠道运动或转运过程的影响），也不应因相互作用而影响活性药物的药代动力学特性。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;"><strong><span style="color:#e36c09;">3）EMA</span></strong></span><br />
<br />
<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">① 全身性作用的口服固体速释制剂，对于口腔分散片或口腔崩解片，应排除口腔吸收。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
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<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">② 原料药不同BCS 类别及制剂的溶出度要求：</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">原料药为BCS Ⅰ类: 制剂符合快速溶出的要求，即在pH1.2、pH4.5和pH6.8的标准溶出介质中，以桨法（50rpm）或篮法（100rpm）（体积≤900 mL），在30 min 内的溶出量≥85%。试验制剂与对照制剂的溶出曲线比较，f2&gt;50。若试验制剂与对照制剂在上述溶出条件下，15 min 内的溶出量≥85%，可认为是极快料药为速溶出制剂，不再需要比较溶出曲线。</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">BCS Ⅲ类：若试验制剂与对照制剂都是极快速溶出的制剂，即在pH1.2、pH4.5和pH6.8的标准溶出介质中，以桨法（50rpm）或篮法(100rpm）（体积≤900 mL），在15 min 内的溶出量≥85%。这种情况下，可以考虑豁免生物等效性研究。</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">一般情况下，与含BCSⅠ类的制剂相比，应更为谨慎地审查含BCS Ⅲ的制剂豁免生物等效性研究的风险（比如特定部位吸收、与吸收部位转运蛋白相互作用的风险、辅料组成以及治疗风险）。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">③ 辅料：对于BCSⅠ和BCS Ⅲ原料药，应使用常规用量的常用辅料。对于可能影响到生物利用度的辅料（如山梨醇、甘露醇、十二烷基硫酸钠或其他表面活性剂）&nbsp;，应了解其对胃肠蠕动、与药物的相互作用、渗透性、与膜转运体之间的相互作用，在试验制剂和对照制剂中应具定性相同、定量相似。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">④ 对于速释复方制剂，复方中所有活性药物成分都应属于BCSⅠ或BCS Ⅲ，并符合相关上述条件。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>&nbsp;
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;"><strong><span style="color:#e36c09;">4）ICH M9：详见CDE官网发布的M9：基于生物药剂学分类系统的生物等效性豁免。</span></strong></span>
</p>
<p style="font-size:17px;font-family:system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-weight:400;color:;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
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<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">基于BCS的生物豁免研究不同地区有不同的指导原则，而在中国现阶段执行的是<strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#007aaa;">ICH M9：基于生物药剂学分类系统的生物等效性豁免</span></strong>，可重点参考这个指导原则进行相关研究。</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">以上是笔者通过研究相关指导原则总结出来的内容，希望对读者有帮助。</span> 
<p class="rich_media_title " style="font-size:22px;font-family:system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-weight:400;font-style:normal;background-color:#ffffff;text-indent:0px;" align="center">
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