Adrian H B Gottschalk

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The development of new therapies is a crucial component of efforts to improve healthcare. Because drug development and FDA regulatory review have historically been lengthy and costly processes, the US Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA), which sought to expedite(More)
To elucidate the mechanisms that lead to sleep-disordered breathing, we have developed a mathematical model that allows for dynamic interactions among the chemical control of respiration, changes in sleep-waking state, and changes in upper airway patency. The increase in steady-state arterial PCO2 accompanying sleep is shown to be inversely related to the(More)
A mathematical model of the three-phase respiratory network proposed by Richter et al. (News Physiol. Sci. 1: 109-112, 1986) is developed and its properties are examined. The model reproduces the experimentally determined trajectories of membrane potential for the five physiologically distinct types of neurons included. Stepwise parameter changes can(More)
Periodicities of ventilation are common in elderly subjects during stage 1/2 sleep. The mechanism producing these periodicities is unknown. We hypothesized that the oscillations in ventilation might be related to oscillations in sleep state. To address this hypothesis, we examined, using cross correlation, the relationship between the oscillations in(More)
to Berndt and Gottschalk from general funds at the Harvard-MIT Division of Health Sciences and Technology is gratefully acknowledged. We thank Ed Hass of the FDA and Roy Gross of MIT for their very significant assistance throughout this project. The views and opinions expressed in this paper are those of the authors, and do not necessarily reflect any(More)
Administration, without whose encouragement this project would not have been possible. We also thank the interviewees in industry, academia and the FDA who generously gave of their time to meet with us. Responsibility for any errors and opinions expressed herein rests solely with the authors.The views expressed herein are those of the author(s) and do not(More)
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