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Quantifying the Impact of a Drug on Gastric Emptying: Measuring the Pharmacodynamic Effect in Clinical Trials
A Rankin, M Paterson, A Connor. Pharmaceutical Profiles Ltd

Many drug classes are known to alter the rate of gastric emptying. Whilst there is no specific regulatory guidance requiring the impact of drugs on GE to be measured, it is important to fully understand the mode of action and the relationship between the pharmacokinetic profile and the pharmacodynamic response.

Building Flexibility ino Phase I Protocols and Early Clinical Development Programs
Lloyd Stevens and Gareth King. Pharmaceutical Profiles

The transition of a drug candidate into Phase I and other early drug development programs is undergoing considerable examination and change. This has largely been brought about by commercial and scientific drivers to reduce attrition rates coupled with an evolving regulatory environment, all of which encourage the pharmaceutical industry to build both scientific focus and flexibility into the drug development program.

Use of gamma scinitigraphy to understand inhaled device/formulation variables on delivery efficiency and
Peter Scholes and Karen Jones. Pharmaceutical Profiles Ltd

Systemic delivery of both small molecules and macromolecules via inhaled therapies is an area of significant ongoing research1. The pulmonary route offers the physiological benefits of a highly vascularised, large surface area for absorption which can promote high bioavailability and a rapid onset of action. For biomolecules such as peptides, proteins and nucleic acid derivatives, inhaled drug delivery can also provide a viable alterative to intravenous administration.

Evaluation of Human Regional Bioavailability to Assess Whether Modified Release Development is Feasible
A Connor, G King and K Jones. Pharmaceutical Profiles

Many modified release (MR) oral formulations rely on bioavailability from the distal regions of the gastrointestinal (GI) tract (i.e. the ileum and colon). Therefore, by assessing the bioavailability of a drug following delivery to the distal intestines, it is possible to determine whether MR formulation development is achievable.

THE OSTEOPROTECTIVE ACTION OF 6-OXA-8a-ANALOGUES OF STEROID ESTROGENS
A.G. Shavva, V.N. Belov, A.Yu. Solovyev, S.N. Morozkina. Saint-Petersburg State University

We synthesized fourteen 6-oxa-8a-estrogens analogues and investigated osteoprotective and uterotropic actions. We demonstrated correlation: every modification in structure of 6-oxa-8-analogues leading to strong (>30%) reduction of uterotropic action induces slump of osteoprotective activity. This allows to make conclusion: main biotarget, responsible for appearance of osteoprotective action is a-estrogen receptor. We found steroid estrogen analogues with cholesterol-lowering properties without u

Whole Body Endogenous Nitric Oxide Production in Patients with Decompensated Liver Disease
Demoncheaux E., Elphick D.A., Dürner M.B., Higgins G.E., Crowther D., Williams E.J., Higenbottam T.W and Gleeson D. University of Sheffield School of Medicine

Increased nitric oxide (NO) production has been implicated in the pathogenesis of the hyperdynamic circulation found in patients with advanced liver disease. There were no differences between patients with liver disease and controls with regard whole body NO production. Our results, in a well characterised set of patients, argue against greater basal NOS-dependent whole body NO production in patients with decompensated liver disease.

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