Protocol development, validation, and troubleshooting of in-situ fiber optic bathless dissolution system (FODS) for a pharmaceutical drug testing

•Despite having technical/analytical advantages FODS is not the chosen technique to support pharmaceuticals’ release testing.•Reasons include a lack of systematic approach for dissolution method development validation and troubleshooting of FODS.•Current work provides a systematic approach for the validation and quantitative assessment for FODS.•Current work describes the technical problems which can arise and possible approaches to troubleshoot these issues.•Troubleshooting steps include modifying or changing instrumental, operational, and data analysis techniques.