Article(id=1322627343512883354, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627316266680781, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1590940800000, acceptedDateStr=2020-06-01, onlineDate=1793268531921, onlineDateStr=2026-10-29, pubDate=1611936000000, pubDateStr=2021-01-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268531921, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268531921, creator=13701087609, updateTime=1793268531921, updator=13701087609, issue=Issue{id=1322627316266680781, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='2', pageStart='97', pageEnd='192', issueExtLink='null', onlineDate='null', pubDate='1611936000000', pubDateStr='2021-01-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268525425, creator='13701087609', updateTime=1793269089393, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322629681875108722, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627316266680781, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322629681879303027, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627316266680781, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=110, endPage=113, ext={EN=ArticleExt(id=1322627343689044123, articleId=1322627343512883354, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Considerations on in vitro phosphate binding experiments for lanthanum carbonate chewable tablets, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Lanthanum carbonate chewable tablets were approved as a phosphate binder indicated to reduce serum phosphate in patients with end stage renal disease by the US FDA in the year of 2004. Lanthanum carbonate is a gastrointestinal (GI) tract locally acting drug. The oral absorption of lanthanum carbonate is very low, so the conventional in vivo bioequivalence study with a pharmacokinetic (PK) endpoint is not feasible. The FDA recommended in vitro dissolution testing and phosphate binding studies to demonstrate bioequivalence of lanthanum carbonate preparations. Based on the literatures and guidance issued by FDA, this article discussed the in vitro phosphate binding research of lanthanum carbonate chewable tablets from the aspects of methodology, experimental design and data analysis, hoping to provide references for the development of the generic drugs.

, authors=Dan ZANG, Jing-yi MA, Min LI, Shu-jie LIU, Li-li GAO, Ying-qi ZHAI, Jin-bo YANG, authorsList=Dan ZANG, Jing-yi MA, Min LI, Shu-jie LIU, Li-li GAO, Ying-qi ZHAI, Jin-bo YANG, authorCompany=null, correspAuthors=Jin-bo YANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322627343923925148, articleId=1322627343512883354, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=碳酸镧咀嚼片体外磷结合试验的一般考虑, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

碳酸镧咀嚼片于2004年由美国FDA批准上市，作为一种磷结合剂用于降低终末期肾病患者血清磷酸盐。碳酸镧是胃肠道（GI）局部作用药物，口服吸收率非常低，不适合采用常规的体内药动学（PK）终点方法评价生物等效性。FDA认为，体外溶出试验和磷酸盐结合研究可用于证明碳酸镧生物等效性。本文在FDA个药指南和文献资料基础上，从方法学、实验设计、数据分析等方面对碳酸镧咀嚼片体外磷结合研究进行探讨，旨在为相关仿制药的研究提供参考。

, authors=张丹, 马婧怡, 李敏, 刘淑洁, 高丽丽, 翟颖奇, 杨进波, authorsList=张丹, 马婧怡, 李敏, 刘淑洁, 高丽丽, 翟颖奇, 杨进波, authorCompany=null, correspAuthors=杨进波, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=VO9NFgpQ2n3m8ofqNdglEw==, magXml=kEeb/6m1HP0w3tFaI7GYTA==, pdfUrl=null, pdf=fBjBRNSwrPTDniGu0NgTtg==, pdfFileSize=841293, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=Pa91zpmKbckRQx3aioG2Pw==, mapNumber=null, fund=null)}, authors=[Author(id=1322627344255275169, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627343512883354, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=zhangd@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627344330772643, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627343512883354, authorId=1322627344255275169, language=EN, stringName=Dan ZANG, firstName=Dan, middleName=null, lastName=ZANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627344414658724, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627343512883354, authorId=1322627344255275169, language=CN, stringName=张丹, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京　100022, bio={"content":"

张丹，女，硕士，助理研究员，主要从事临床药理相关技术审评工作。联系电话：（010）85243576，E-mail：zhangd@cde.org.cn。

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张丹，女，硕士，助理研究员，主要从事临床药理相关技术审评工作。联系电话：（010）85243576，E-mail：zhangd@cde.org.cn。

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