Regulatory requirements for marketing fixed dose combinations
The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio is safe and effective and when all...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2010-01-01
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| Series: | Perspectives in Clinical Research |
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| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=4;spage=120;epage=123;aulast=Jayasheel |
| _version_ | 1818246002078908416 |
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| author | B G Jayasheel |
| author_facet | B G Jayasheel |
| author_sort | B G Jayasheel |
| collection | DOAJ |
| description | The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio is safe and effective and when all of the actives contribute to the overall therapeutic effect. Such combinations of drugs are particularly useful in the management of chronic diseases. In addition, there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution and reduced development of resistance in the case of antimicrobials. Above all, FDC therapy reduces pill burden and improves medication compliance. Although, FDCs seem to be ideal under certain pre-defined circumstances, if a dosing adjustment is warranted, there may not be an FDC available in the most appropriate strength for the patient and if an adverse drug reaction occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945, India) states the requirements for marketing approval of various types of FDCs. The same is further elaborated in this article to provide a detailed guidance including the clinical trial requirements. However, the heterogeneity of the therapeutic field makes it difficult to develop a standard guidance document. |
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| format | Article |
| id | doaj.art-2f3cffcfdadf42a0952ff68faba229c9 |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-12-12T14:41:53Z |
| publishDate | 2010-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-2f3cffcfdadf42a0952ff68faba229c92022-12-22T00:21:12ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852010-01-011412012310.4103/2229-3485.71768Regulatory requirements for marketing fixed dose combinationsB G JayasheelThe development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio is safe and effective and when all of the actives contribute to the overall therapeutic effect. Such combinations of drugs are particularly useful in the management of chronic diseases. In addition, there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution and reduced development of resistance in the case of antimicrobials. Above all, FDC therapy reduces pill burden and improves medication compliance. Although, FDCs seem to be ideal under certain pre-defined circumstances, if a dosing adjustment is warranted, there may not be an FDC available in the most appropriate strength for the patient and if an adverse drug reaction occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945, India) states the requirements for marketing approval of various types of FDCs. The same is further elaborated in this article to provide a detailed guidance including the clinical trial requirements. However, the heterogeneity of the therapeutic field makes it difficult to develop a standard guidance document.http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=4;spage=120;epage=123;aulast=JayasheelClinical trialsfixed dose combinationsIndiamarketing approvalregulatory |
| spellingShingle | B G Jayasheel Regulatory requirements for marketing fixed dose combinations Perspectives in Clinical Research Clinical trials fixed dose combinations India marketing approval regulatory |
| title | Regulatory requirements for marketing fixed dose combinations |
| title_full | Regulatory requirements for marketing fixed dose combinations |
| title_fullStr | Regulatory requirements for marketing fixed dose combinations |
| title_full_unstemmed | Regulatory requirements for marketing fixed dose combinations |
| title_short | Regulatory requirements for marketing fixed dose combinations |
| title_sort | regulatory requirements for marketing fixed dose combinations |
| topic | Clinical trials fixed dose combinations India marketing approval regulatory |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=4;spage=120;epage=123;aulast=Jayasheel |
| work_keys_str_mv | AT bgjayasheel regulatoryrequirementsformarketingfixeddosecombinations |