Clinical Pharmacology Considerations for Development of β Lactamase Inhibitor Combination with Antibiotics.

The shrinking drug pipeline for antibacterial drugs has made it very precious to discover and develop novel drugs in this space. In this context, the recent approvals of β lactamase inhibitors with either cephalosporin or penem as combination drugs are welcome news to the community. There are number of β lactamase inhibitors with suggested partnered drugs that are currently in various stages of drug development. The focus of this manuscript is to provide some perspectives on clinical pharmacology considerations that may aid in the successful development of such combination drugs. In this regard, a broad framework which includes pharmacokinetics (PK), pharmacodynamics (PD) and PK/PD guided surrogate strategies are provided to enable an informed dosing decision of the combination agent.