Questcor Pharmaceuticals, Inc.

Mallinckrodt Ard IP Limited

Globomax LLC

David Young

Steve Cartt

Leonid V Gibiansky

Michael Petrone

Laura S Lehman

Colm B Farrell

Sian E Bigora

David Tierney

Patrice Becker

William R Gillespie

Anastassios D Retzios

Carol B Trapnell

James Knight

Theresa A Shepard

Ruth Oliver

Provided herein are methods of treatment of acute respiratory distress syndrome comprising administration of adrenocorticotropic hormone (ACTH). or fragment, analog, complex or aggregate thereof, or any combination thereof, to an individual in need thereof.

ACTH for treatment of acute respiratory distress syndrome

A biological modeling system and method for enhanced computer-aided analysis of biological response data provides information synthesized from immediate and extended release in vivo data and in vitro data. An executable model of a biological system is developed from information and structures based on the data. In a preferred embodiment, a two stage approach to modeling is used in the development of an IVIVC. The first stage of the procedure is deconvolution, where the percentage of drug absorbed is determined. In the second stage, the in vivo percentage absorbed data is correlated to the in vitro fraction or percentage dissolved data. This correlation then represents a point-to-point relationship between the in vitro dissolution and the in vivo input rate of the drug from the dosage form. In such a correlation, the in vitro dissolution and in vivo absorption profiles are either directly superimposable or may be made to be superimposable by the use of a scaling factor. Prior to the deconvolution stage, a unit impulse response function can be determined from immediate-release concentration-time data. This impulse response function is used in the deconvolution process to determine the in vivo percent absorbed for the extended release formulations. A nonlinear IVIVC model is developed that can incorporate time-scaling and time-shifting into the model if needed. After the two-stage modeling is completed, the predictability of the developed IVIVC model is evaluated by both internal and external validation.

Tool for in vitro-in vivo correlation

The present invention is directed to a method for the treatment of gastroparesis by the use of metoclopramide nasal formulation.

Nasal administration of agents for the treatment of gastroparesis

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Ellicott City, MD, United States of America

David Young