The role of human absorption studies in successful product development was examined recently in the first in a series of web-based seminars
The role of human absorption studies in successful product development was examined recently by one of the pharmaceutical industry's leading authorities in oral drug delivery in the first in a series of webinars (web-based seminars).
The on-line sessions have been designed by Pharmaceutical Profiles to address some of the key challenges facing all companies developing pharmaceutical products.
The first webinar - 'attended' on-line by more than 50 key industry delegates - was delivered by Professor Ian Wilding, a frequent speaker at international meetings and a respected authority on drug delivery and intestinal absorption.
Following the success of the event - the first of its kind in this area of the pharmaceutical and biotechnology industries - the company is already planning the second webinar for September this year.
Professor Wilding, Chairman of Pharmaceutical Profiles, served as an expert scientist for the FDA in the area of food effects on drug bioavailability and is currently the only European scientist working with PQRI (an FDA/AAPS initiative) examining US regulatory guidance in the area of oral biopharmaceutics.
He is also on the Advisory Board for the University of Nottingham Institute of Enterprise and Innovation and is a member of the steering committee for the East Midlands MediLink programme, designed to improve connectivity between universities, hospitals, SMEs and large companies within the healthcare discipline in the region.
He explained; "Pharmacokinetic (PK) or bioavailability issues should be taken into account when drugs are selected as full development candidates.
"However, the difficulty still exists to screen for human PK properties. "The correlation between pre-clinical animal models and man is often poor.
"However, one of the main reasons for the prediction dilemma has been the limited understanding of what controls human drug absorption.
"New techniques for assessing which factors influence oral drug absorption in different regions of the gastrointestinal tract have gone some way in addressing this.
"Pharmaceutical and drug delivery companies are undertaking human absorption studies to create more reliable 'route maps' for developing new drugs with complex PK properties.
"Such studies are ideal for generating radical innovations in development by providing mechanisms to make informed decisions about the likely chance of bioavailability success for a candidate drug through optimised formulation development.
"That is the process this first webinar examined and we plan other similar initiatives in the future."
