A general, systematic procedure is presented to support the development and
statistical verification of dynamic process models. Within this procedure,
methods are presented to address several key aspects, such as structural i
dentifiability and distinguishability testing, as well as optimal design of
dynamic experiments for both model discrimination and improving parameter
precision. A novel optimisation-based approach is introduced for testing of
model structural identifiability and distinguishability, involving semi-in
finite programming and max-min problems. The design of dynamic experiments
is cast as an optimal control problem within a framework that enables the c
alculation of optimal sampling points, experiment duration, fixed and varia
ble external control profiles, and initial conditions of a dynamic experime
nt subject to general constraints on inputs and outputs. Within this framew
ork, methods are presented to provide experiment design robustness, account
ing for parameter uncertainty. The procedure is demonstrated through a prac
tical biotechnology example. (C) 2000 Elsevier Science Ltd. All rights rese
rved.