{"title":"仿制药在精神药物治疗中的有效性。","authors":"Richard Kumet, Alan J Gelenberg","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>In order to win FDA approval, generic drugs must demonstrate bioequivalence, namely the ability to achieve blood levels similar to those of the innovator ones on which they are based. They must have the same active ingredients, be identical in strength, dosage form, and route of administration, and be manufactured under strict FDA standards. Because basic efficacy and safety studies are not required, their cost is significantly lower. However, there can be important differences between the innovator drugs and generics, as well as among the generics themselves. More research needs to be done to establish true comparability.</p>","PeriodicalId":87179,"journal":{"name":"Essential psychopharmacology","volume":"6 2","pages":"104-11"},"PeriodicalIF":0.0000,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The effectiveness of generic agents in psychopharmacologic treatment.\",\"authors\":\"Richard Kumet, Alan J Gelenberg\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>In order to win FDA approval, generic drugs must demonstrate bioequivalence, namely the ability to achieve blood levels similar to those of the innovator ones on which they are based. They must have the same active ingredients, be identical in strength, dosage form, and route of administration, and be manufactured under strict FDA standards. Because basic efficacy and safety studies are not required, their cost is significantly lower. However, there can be important differences between the innovator drugs and generics, as well as among the generics themselves. More research needs to be done to establish true comparability.</p>\",\"PeriodicalId\":87179,\"journal\":{\"name\":\"Essential psychopharmacology\",\"volume\":\"6 2\",\"pages\":\"104-11\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2005-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Essential psychopharmacology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Essential psychopharmacology","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
The effectiveness of generic agents in psychopharmacologic treatment.
In order to win FDA approval, generic drugs must demonstrate bioequivalence, namely the ability to achieve blood levels similar to those of the innovator ones on which they are based. They must have the same active ingredients, be identical in strength, dosage form, and route of administration, and be manufactured under strict FDA standards. Because basic efficacy and safety studies are not required, their cost is significantly lower. However, there can be important differences between the innovator drugs and generics, as well as among the generics themselves. More research needs to be done to establish true comparability.