Regulatory challenges

VI. New Regulatory Challenges in Assessing the Use of Pharmacogenomic Diagnostics and the Use of Targeted Therapeutics... 

The future of safety pharmacology will depend, in part, upon the scientific and technological advances and regulatory challenges that envelop pharmaceutical development. 

Concern about the quality of botanical products poses another regulatory challenge. Most botanical products are complex and variable mixtures of constituents too numerous to characterize individually. For many preparations, active ingredients have not been identified and it is thus difficult to quantify strength or potency of the botanical product. Because of the biological nature of botanical products, the assessment of their impurity and stability is often more problematic than that of nonbotanical pure drugs. 

Thanks to the persistent efforts of Michael Leventhal, these 25 chapters, which are written by leading practitioners in each of these areas, provide coverage of the primary approaches to the fundamental regulatory challenges that must be overcome to manufacture successfully a deliverable and stable new drug. 

Development of a multicellular organism presents the most complex regulatory challenge. The fate of cells in the early embryo is determined by establishment of anterior-posterior and dorsal-ventral gradients... 

This section will discuss some of the compliance difficulties typically encountered in today s cleaning programs. These are areas that continue to cause the industry major regulatory challenges. 

Getting Started with a Combination Product. Part I Overcoming the Regulatory Challenges in This Ever-Expanding Field Yields Rewards. http //www.devicelink. com/mddi/archive/03/03/018.html... 

McKenna DJ. Clinical investigations of the therapeutic potential of ayahuasca rationale and regulatory challenges. Pharmacol Ther 2004 102(2) lll-29. 

It is estimated that 80 percent of the population consults with traditional healers before they seek access to conventional medicines. The use of indigenous African medicine is thus quite prevalent cind presents medicine regulatory challenges as the materials are obtained from the fauna and flora of the country. 

The potential regulatory challenges of personalised medicine. Available at www.mhra.gov.uk. 

A Regulatory Challenges for the Potential Use of Ecological Models in Risk Assessments of Plant Protection Products... 

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