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Dosing 30 to 750 mL/day dosing of 500 mg extract is nontoxic Contraindications 금지사유 (contraindication: (특정 약물 치료의) 금지사유) Contraindications have not been identified Pregnancy/Lactation 임신 및 수유기간 Information regarding safety and efficacy in pregnancy and lactation is lacking

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• In February our partner Santen announced that they increased the sample size of the ongoing AVANTE Phase 2 randomized trial assessing the efficacy of DE-122 the ophthalmic formulation of TRC105 in combination with Lucentis in patients with wet AMD The primary endpoint of the trial is unchanged and measures best corrected visual acuity Top-line data from the study is expected in the

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Potent compound safety requires the same degree of assessment as the risks of inadequate containment lack of exposure controls and improper handling of the API can be significant (for example causing an adverse health effect in workers handling the drug or impeding speed to market) SafeBridge Consultants Inc of Mountain View California has created and implemented a metric that determines

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Assessing potent compound safety capabilities at CMOs A W Ader J P Farris R G Sussman Contract Pharma 2007 VIEW 4 EXCERPTS HIGHLY INFLUENTIAL Scientific and practical considerations for the development of occupational exposure limits (OELs) for chemical substances D M Galer H W -Y Leung Robert G Sussman R J Trzos Medicine Regulatory toxicology and

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The lead compound was the first mole- director Aventis University degree in molecular medicine in onco- clinical trials currently investigating the potential dical Director AstraZeneca Jorge was appointed Since GSK: The naima States reinforces its leadership in the field of a number of their daily activities while relieving seases rare diseases neurosciences and oncology peptides and

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This analysis should challenge capability and knowledge in potent compound safety (both occupational and environmental) assessing the organization's understanding of cross-contamination risk of how the product might be affected by other compounds produced at the prospective site and how current products might be affected by possible introduction of the new product Key elements to be

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The SafeBridge potent compound safety certification programme provides drug innovators with an independent assessment of the manufacturing company's capabilities to safely produce potent APIs and drug products The programme also provides pharmaceutical manufacturers with a metric to evaluate their own performance and to encourage continuous improvement The SafeBridge certification of the

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Cardiovascular diseases represent a complex group of clinical syndromes caused by a variety of interacting pathological factors They include the most extensive disease population and rank first in all-cause mortality worldwide

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Different pieces of equipment offer different containment performance and knowledge of equipment capabilities is required when selecting equipment for a given purpose and potent material The handling or manufacture of potent materials will invariably centre around a piece of process equipment in which dry powders are created or processed

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