Strategy of fixed-dose combination innovative development

Abstract

Abstract: Development of fixed-dose combination finished pharmaceutical products (FDC-FPPs, FDCs) is an innovative process and has become one of the breakthrough strategies for removing the bottlenecks in drug discovery. Formulating prescription of FDCs is based on drug interactions theory. The principle of formulating prescription is taking full advantage of the drugs' effects with a same remedy goal, then proceeding a demonstration of the prescription and multi-factor and multi-level analyses, verifying of clinical combinations, confirming of the goal prescription, finally accessing the normalize research and trials of new drug development. The whole process of FDCs research and development (pharmacy, pharmacodynamics, pharmacokinetics, toxicology and clinical trials) is as strict as such of the complete innovative drug, and need to optimize the formula and the ratio of prescription. This review summarizes the principles of formulating prescription, development strategy, and technical requirements specification of FDCs.

Key words: Development of FDCs, Drug interactions theory, Multi-factor and multi-level analysis technology, Principles of formulating prescription, Technical requirements specification

CLC Number:

R965.1

YUAN Bing-xiang, CHEN Li-na, WANG Bing. Strategy of fixed-dose combination innovative development[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(10): 1175-1181.

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