Pharmaceutical Profiles To Host Open Forum At AAPS 2008 Real-Time Adaptive Early Clinical Development Debate
Pharmaceutical Profiles is making important contributions to the 2008 AAPS Annual Meeting and Exposition (Nov. 16-20, Atlanta, USA). An integrated formulation development, manufacture and clinical evaluation platform coupled with technologies to address drug bioavailability issues underpin the company's pacesetting approach to early drug development protocols. As part of the conference program, Pharmaceutical Profiles will chair and contribute to an interdisciplinary Open Forum on flexible clinical protocols and present six scientific posters. Senior members of the company team will be available for discussions on exhibition booth #1749.
'Real-time adaptive early clinical development - an open debate on pharmaceutical, clinical and regulatory challenges', takes place on November 20th at 13:30 - 17:00. Dr Lloyd Stevens, Senior Research Fellow at Pharmaceutical Profiles will chair the session with experts from Pfizer Inc., Abbott Laboratories, Eli Lilly and Company, and the US Food and Drug Administration. Dr Peter Scholes, VP Pharmaceutical Sciences will contribute expertise on how formulations can be manufactured and tested in the clinic within 24 hours, thereby enabling within-study decision-making regarding formulation selection and dose level . Participants will debate, in depth, the opportunities, challenges and regulatory framework of real-time adaptive early clinical development.
Scientific poster presentations will demonstrate the application of Pharmaceutical Profiles solutions:
- Phase I and Early Clinical Studies to Determine Intravenous Pharmacokinetics and Absolute Bioavailability Using Tracer Intravenous Doses of 14C-Radiolabelled Drug: L. Stevens, Pharmaceutical Profiles
- Regulatory Requirements and Experiences for Microdose/IVmicrotracerT studies in the UK: LA Stevens, SE Dobbin, RE Bacon, Pharmaceutical Profiles
- Absorption of omaprazole from the gastrointestinal tract: V. E. Cowles, S. E. Hou, R. Fell, A. Connor, P. Evans, I. Wilding, B. Berner, Depomed, Inc, Pharmaceutical Profiles, Ian Wilding Associates
- Radiolabelling technologies for scintigraphic evaluation of oral pharmaceutical dosage forms: J. C. McDermott, P. D. Scholes, A. C. Connor, Pharmaceutical Profiles
- Direct radiolabelling of fluticasone propionate for in vivo scintigraphic evaluation of a suspension formulation: W. Lin, I. Chaudry, M. Pickford, J. McDermott, P. D. Scholes, J. Naumann, Pharmaceutical Profiles and Dey Laboratories
- Future applications of gamma scintigraphy in inhaled drug development: M. Limb, P. D. Scholes, F. Sadler, Pharmaceutical Profiles
The Pharmaceutical Profiles team is expert in early clinical drug development. AAPS 2008 is the world's largest gathering of pharmaceutical scientists, which aims to, "Provide a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to health." (www.aapspharmaceutica.com). Pharmaceutical Profiles interdisciplinary Open Forum is set to exemplify this objective. It offers delegates the opportunity to examine and debate flexible approaches and real-time early adaptation protocols that hold the potential to save development time and money. www.pharmprofiles.com
About Pharmaceutical Profiles
Pharmaceutical Profiles provides drug development support to most of the top pharmaceutical and biotechnology companies around the world.
A specialist in clinical drug development, the company has innovative technology and is pioneering a novel approach to rapid formulation development, manufacturing and early clinical testing. Pharmaceutical Profiles has around 75 highly qualified staff. Facilities include a phase I GCP clinical unit, a GMP facility for the manufacture of Investigational Medicinal Products (IMPs), and formulation R&D facilities all integrated under one roof, just south of Nottingham in the UK.
The company's world leading expertise in oral drug delivery has assisted the development of over 100 small molecules, peptides and protein therapeutics, including over 40 marketed drugs. In addition, the Pharmaceutical Profiles team has supported the development of the majority of inhaled drug delivery devices and formulations on the market today.
SOURCE: Pharmaceutical Profiles