Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics.

ABSTRACT: The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability

SUBMITTER: Li Z 

PROVIDER: S-EPMC5800388 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature