The following recommendations are intended to facilitate the development and quality control of the FDCs that are the subject of this meeting. They are not necessarily listed in order of priority.

Pharmaceutical development

1 Publish formulations and methods of manufacture for the FDCs in question.

2 Consider the possibility of WHO purchasing a registration package for a generic and making it publicly available. Such a package would include inter alia formulation, method of manufacture (with in- process controls and limits), methods of QC testing and limits, stability data, bioavailability data.

3 Publish preformulation information on the drugs in question, including information on stability. The format of the series Analytical profiles of drugs substances and excipients⁴² could serve as a model.

4 Determine whether the Biopharmaceutical Classification System³ can reliably be applied to FDCs. If yes, then ascertain the GI permeability of of the drugs in question.

Quality control

5 Develop and publish monographs on the individual APIs and finished products in question where these do not already exist.

6 Ensure that reference standards are available for the drugs in question, and at a price that is acceptable to the manufacturers and the regulatory authorities involved.