Unique Risks, Benefits, and Challenges of Developing Drug-Drug Combination Products in a Pharmaceutical Industrial Setting

The Wider Use of Fixed-Dose Combinations Emphasizes the Need for a Global Approach to Regulatory Guideline Development

“…Combination studies are likely to be seen as not only advantageous but necessary from the early stages of clinical development. 40 As expressed by the World Health Organization as long ago as 2005, ''the development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective,'' and ''it is important that access to useful, new FDCs should not be delayed by unnecessary constraints''. 41 Although this project focused on FDCs, the topics raised highlight some of the major challenges that currently face the regulatory world.…”

Convergence of Strategies and Technologies - Next Generation Biocosmeceuticals and Biopharmaceuticals Products

“…FDCs are products that comprise at least two (often more) active pharmaceutical ingredients (APIs) combined in a single dosage form with fixed doses. New intellectual property, comparable safety, increased compliance and efficacy, as well as sustained or increased revenues are associated with the 'multi-target' approach that constitute FDCs [10][11][12][13]. For other complex therapeutic areas such as CNS diseases and disorders, the trend is more recent.…”

Drug–drug combinations revisited

“…The search for increased efficacy has raised interest in developing drug–drug combinations directed towards independent targets involved in disease pathology 6 7. Systems pharmacology involving holistic systems approaches now allows such targets to be identified 8 9.…”

“…This mistrust continues today 7 13 14. Collected arguments for and against the wider use of medicine combinations are given in table 1.…”