Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date Safety Evaluation on Extractables and Leachable Dr Clemens Günther, at Bayer AG, R&D Pharmaceuticals and Tino Otte at Intertek Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals 5 months ago | 159 mins Common Challenges in Evaluating the Reproductive System in Nonclinical Justin Vidal, PhD, DVM, DACVP According to the ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Au... 6 years ago | 53 mins Targeting Notch Altered Patient Derived Xenografts (PDX) with AL101 Joel Kaye, PhD, VP Research & Nonclinical Development, Ayala Pharmaceuticals Notch pathway activation has been implicated in the development of cancer. Notch cleavage by γ-secretase frees the Notch intracellular domain (NICD), ... 3 years ago | 28 mins Gene and Cell Therapy – An Overview of the Current and Changing Regulatory Mark D. Johnson, MS; Scott E. Boley, PhD, DABT Gene and Cell Therapy – An Overview of the Current and Changing Regulatory Requirements and Study Design for Nonclinical Safety Evaluation Nonclinica... 5 years ago | 72 mins The Otic Chronicle │ A Guide to Conducting Nonclinical Auditory Studies Rachel Tapp, MS, LATG Developments for new therapeutics to target various aspects of auditory system dysfunction is on the rise within the drug development industry. Join R... 6 years ago | 60 mins Risk Assessment of Extractables and Leachables... Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals Full title: Risk Assessment of Extractables and Leachables in Different Phases of Development. As the knowledge on the manufacturing process evolves ... 2 years ago | 127 mins Common Technical Challenges with Outsourcing Nonclinical Studies Scott Boley, PhD, DABT, Greg Ruppert, BA A primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy ... 6 years ago | 61 mins How Do I Get My Compound Into Phase I? Scott Boley, PhD, DABT, Greg Ruppert, BA Careful assessment of the relationship between efficacy and toxicity is vital to drug developers as they seek advancement of their compounds. Nonclini... 6 years ago | 58 mins
