By Dr. Jian Liu, Dr. Thomas N. Chiesl Dr. Fuh-Wei Tang Dr. Marika Kamberi

Published in: Pharmaceutical Outsourcing

Published on: August 22, 2018

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. These products may include “single-entity” items such as monoclonal antibodies mixed with a therapeutic chemotherapy drug, devices impregnated or coated with drugs such as drug eluting stents, pacing lead with steroid-coated tip, catheter with antimicrobial coating, transdermal patch and or prefilled drug delivery systems such as insulin injectors. “Co-packaged” combination products are two or more separate classes of product contained in a single package or as a unit and finally “cross-labeled” combination products encompass individual products that are provided separately but are specifically labeled for use together.1 However, products intended to be used together may not strictly meet the regulatory definition of a combination product if, for example, a syringe is marketed for general delivery of unspecified drugs. Additionally, two or more of the same class of medical product (drug-drug, biological- biological, device-device) or a medical product combined with a non- medical product such as a dietary supplement does not constitute a combination product.

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