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Developing a better measure of gastric and esophageal acid exposure Eisai, Inc. wanted to provide clinical evidence of the efficacy of its new proton pump inhibitor, rabeprazole, as part of its New Drug Application (NDA) to the FDA. The company asked SFO to analyze data from 24-hour recordings of gastric and esophageal pH from 30 GERD patients. However, commonly used analyses permitted only a semi-quantitative assessment of the acidity. SFO's solution was to develop Integrated Acidity - a method of analyzing pH data that fully quantified gastric and esophageal acid exposure over time. Using this method, we could quantify acid exposure in the 30 GERD patients and determine precisely how much this acid exposure decreased during treatment with rabeprazole. This method has also been accepted by the FDA; and companies now routinely provide data using this method to the FDA. [View SFO's technique for determining integrated acidity from pH recordings in References 330 and 331.] Providing support for drug claims Eisai used SFO's Integrated Acidity analysis to support its proposed dosage for the new drug and its claim that the drug achieved 80% of its maximum effect on gastric acidity on the first day of dosing. FDA agreed with the analysis and approved the drug.