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星�；蹆�榮譽(yù)版主 (職業(yè)作家)
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[求助]
請教RLD和RS的區(qū)別 已有1人參與
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在FDA上看到一個(gè)產(chǎn)品有RLD也有RS，但是兩者不一個(gè)廠家，請教RLD和RS到底有何區(qū)別，單從字面講，似乎RS更令人困惑。 MYLAN的是RS，但不是RLD；ASTRA的在橙皮書檢索下是RLD，但在drugs@FDA搜索出來的RLD項(xiàng)下又都是NO，很困惑，求解。 1.png 2.png |
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Reference Listed Drug and Reference Standard A reference listed drug (21 CFR 314.3(b)) means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA. Generally, a reference listed drug is a drug product approved in a new drug application under section 505(c) of the FD&C Act based on full reports of investigations of safety and effectiveness. A reference standard is the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval. FDA generally selects a single reference standard that ANDA applicants must use in in vivo bioequivalence testing. Ordinarily, FDA will select the reference listed drug as the reference standard. However, in some instances (e.g., where the reference listed drug has been withdrawn from sale and an ANDA is selected as the reference standard), the reference listed drug and the reference standard may be different. FDA has identified reference listed drugs in the Prescription Drug Product and OTC Drug Product Lists. Forthcoming, FDA will identify reference listed drugs in the Discontinued Drug Product List. These identified reference listed drugs represent drug products upon which an applicant can rely in seeking approval of an ANDA. FDA intends to update periodically the reference listed drugs identified in the Prescription Drug Product, OTC Drug Product, and Discontinued Drug Product Lists, as appropriate. FDA also has identified in the Prescription Drug Product and OTC Drug Product Lists reference standards to which the in vivo bioequivalence is compared. These identified reference standards represent the FDA’s best judgment at this time as to the appropriate comparator for purposes of in vivo bioequivalence testing. In some instances when a listed drug is not designated as a reference listed drug, such listed drug may be shielded from generic competition. If FDA has not designated a reference listed drug for a drug product the applicant intends to duplicate, the potential applicant may ask FDA to designate a reference listed drug for that drug product. Potential applicants should consult agency guidance related to referencing approved drug products in ANDA submissions for information on submitting such a request. If the request is granted, the listed drug will be designated as a reference listed drug, in which case an ANDA citing the designated reference listed drug may be submitted. Section 1.7, Therapeutic Equivalence Evaluations Codes (products meeting necessary bioequivalence requirements) explains the character coding system (e.g., AB, AB1, AB2, AB3...) for multisource drug products listed under the same heading with two reference listed drugs. A potential applicant should consult agency guidance related to referencing approved drug products in ANDA submissions for information on submitting a request for selection of a reference standard. FDA may, on its own initiative, select a new reference standard when doing so will help to ensure that potential applicants have adequate information required for in vivo bioequivalence studies, e.g., in the event that the listed drug currently selected as the reference standard has been withdrawn from sale for other than safety and efficacy reasons. Historically, there were two situations in which two listed drugs that had been shown to be bioequivalent to each other had both been identified by the symbol “+” in the Orange Book. The first situation was when the in vivo determination of bioequivalence is self-evident and a waiver of any in vivo bioequivalence may be granted. The second situation was when the bioequivalence of two listed products may be determined through in vitro methodology. If an applicant has a question related to the appropriate reference standard, it is recommended that an applicant planning to conduct an in vivo bioequivalence study submit a controlled correspondence to the Office of Generic Drugs. |
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橙皮書里的我也看了，我的情況是:原研有3個(gè)規(guī)格，都是RLD，其中最大規(guī)格的同時(shí)也被定為了RS。我仿制的是小規(guī)格，那也就是說我仿制的是小規(guī)格的就選對應(yīng)的小規(guī)格的RLD作參比就行？到時(shí)候做BE再選被定為RS的大規(guī)格？這樣藥學(xué)和BE不就脫節(jié)了嗎？最起碼我也得用大規(guī)格的參比先研究一下溶出，跟仿制的小規(guī)格的對比一下的吧？所以我覺得藥學(xué)應(yīng)該選對應(yīng)規(guī)格的同時(shí)還行增加大規(guī)格的RS研究，然后BE用大規(guī)格的RS。請大俠指正。 發(fā)自小木蟲Android客戶端 |
5樓2017-02-19 23:47:07
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