DSE Consulting White Papers
The DSE Consulting Principal has written white papers (WP) on important aspects of the drug development process. The titles and short summaries for each of these WP’s are given below. To download a complete copy of a particular WP , click on the desired WP.
•Developability: A Science for Discovery Lead Candidate Selection
Preliminary in vitro and in vivo experiments can assess the developability of discovery leads for human use. Positive results allow earlier and more cost-effective entry into clinical trials with well-designed, data-productive clinical protocols. This WP discusses the types of developability assessment experiments that can be conducted to more effectively characterize drug discovery leads and to select the best lead for preclinical drug development.
• Bioanalytical Chemistry Methods: Development and Validation
A lead candidate has been selected for development and definitive pharmacokinetic and toxicology studies are scheduled to begin. To support these research efforts, a bioanalytical chemistry method is required. First this method needs to be developed and validated for each matrix and each species to be used in the preclinical research studies. The WP discusses the experiments necessary to validate a method to meet present regulatory agency requirements.
• Selection and Monitoring of Contract Research Organizations
Once a decision has been made to outsource any of the various aspects of the drug development process, careful selection and monitoring of CROs are necessary to ensure that the research studies are conducted as designed and are completed on time and within budget. This WP describes techniques for CRO evaluation.
• Drug Discovery and Development – Some Interesting Math
How much does it cost to discover leads, characterized the attributes (and possibly determine unacceptably demerits) of discovery leads, and conduct the necessary preclinical development studies on a selected drug candidate to support an first-in-human (FIH) clinical trial? This WP discusses the time and cost for these activities and compares them with the time and cost for clinical development of a drug candidate.
Requests to receive a hard copy of any of these white papers or to be put on the mailing list for future DSE Consulting white papers can be made by calling 512-285-4908 or 512-264-4730.
