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CRETICOS Dynavax Technologies [1998 present] Consultant To provide advice and expertise with regard to therapeutic applications and the company's novel therapeutic vaccines in the field of allergic respiratory disease and or related areas. Stallergenes [1996 1999] Consultant To inform and advise company with regard to therapeutic considerations and marketing issues in the field of allergy. ALK Abello [2000 present] Consultant To provide advice regarding therapeutic methodologies and current marketing trends in the field of immunology. Aventis Pharmaceuticals [2002 present] Consultant Member of Scientific Advisory Board To review U.S. and European clinical trial data and provide input for design and protocol development of the company's novel therapeutic compounds cytokine antagonists immunomodulatory compounds second-generation inhaled corticosteroids third-generation antihistamines ; . GlaxoSmithKline [2002 present] Member of International Scientific Advisory Board To review clinical trial decisions protocol development marketing issues related to the company's asthma and rhinitis product line. Their ruling on this yet. In addition, Pfizer is moving carefully right now on roflumilast because it has its own PDE4 in development. Reportedly, there is no excess of GI toxicity nausea or vomiting ; with roflumilast at expected doses, but there is some emetic potential at high doses. A speaker said, "There is less GI toxicity with drugs that cone on slowly rather than are given by bolus, and roflumilast is naturally slow release." However, several sources warned that, though roflumilast appears to look promising at this point, it has not been published. Roflumilast does appear efficacious. A speaker said, "In moderate asthma, roflumilast was as effective as inhaled steroids, and it acts very much like an inhaled steroid.In a Phase III study in COPD, there was not much difference in efficacy between 250 g day and 500 g day." Another speaker said, "Roflumilast is 2 log more potent than Ariflo in inhibiting eosinophils, because atenolol.
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Participants also identified Bioequivalence as a second priority to address the issue of BE implementation and established a working group WG BE ; . Among the main responsibilities of the WG BE were the development of a set of criteria for bioequivalence-bioavailability testing of generic drug products, implementation of technical educational seminars on BE; and, identification of ways to follow up BE implementation in the Region. The II Pan American Conference November 1999 ; established the Pan American Network for Drug Regulatory Harmonization PANDRH ; and rules and regulations for the Network and its working groups. According to those regulations, harmonized proposals developed by the WGs are to be presented at the Conferences for their adoption or approval. 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