Potent Compound Slideshare Presentation
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Provides a brief overview of the upcoming webinar on potent compound safety. Designed for industrial hygienists, engineers, and quality control personnel in the biotechnology, pharmaceutical, and medical device industry.
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Potent Compound Slideshare Presentation
- 1. At Affygility Solutions, we know… Affygility Solutions ■ 303-884-3028
- 2. …you’re under time pressures
- 3. We know…
- 5. That’s why…
- 6. Affygility Solutions has created.. Dean M. Calhoun, CIH President Host Joe Nieusma, Ph.D. Sr. Toxicologist Co-presenter
- 8. …exciting.
- 10. …fast-paced.
- 12. …informative. Module 2: Toxicology 101 Module 1: Introduction to Potent Compounds Module 3: Industrial Hygiene Module 4: Intermediate Toxicology Module 5: Banding & Control Strategies
- 14. What is a Potent Compound?
- 15. You will learn…
- 16. …basic & intermediate toxicology
- 18. …how to evaluate compounds DISCOVERY DEVELOPMENT LAUNCH Target Selection, Assay Development and High Throughput Screening Lead Optimization Candidate Selection Process Exploratory Development Safety / Feasibility Tolerability / Efficacy Registration Market Introduction Phase II a/b & III Phase I Phase IV MORE DATA 0
- 20. …case histories Estradiol Testosterone Progesterone 4-aminopyridine
- 21. You will be engaged in…
- 23. You will be exposed to…
- 24. …new exposure control principles.
- 25. You will find out…
- 26. why…
- 27. ..that this isn’t your normal presentation.
- 28. That this is…
- 29. Next series begins September 10th, 2009 go to: http://affygility.com/seminars/potent.html Affygility Solutions ■ 303-884-3028
Notes de l'éditeur
- …your time is limited.
- this at the end of the series because you get it…you understand.
- Module 1: What we’re covering today: The definition of a potent compound, the overall drug development process and how potent compound safety fits into the process. Additionally we will review some case studies.Module 2: Introductory toxicologyModule 3: Industrial hygiene sampling; using total dust vs. compound specific methods; wipe sampling; area vs. personal sampling; statistical analysis of resultsModule 4: advance toxicology including carcinogenicity; reproductive toxicology; genotoxicology; and moreModule 5: Control banding; engineering controls; administrative controls; and personal protective equipment
- Traditionally conducted in rats and mice. Two years is life-expectancy- mimics lifetime exposureCost = 1.2 M Seeks to estimate incidence of cancer to 1/1,000,000Dosing is appropriate for route of exposure/administrationUnder FDA Guidelines these are GLP studies and an pre-agreement meeting on doses is required In drug development these occurred in late stage of development and even after approvalDose species (rats and mice) 4 Dose Groups including Control 50-60 Animal Group/Gender = 480 animals Daily Dosing Clinical Observations Clinical Pathology Assessment Gross and Histologic Assessment of Most Tissue Blood Levels of Drug Tabulation of tumor type, tumor incidence Statistical Evaluation Live Phase= 2 year; Data Processing = 1 yearDoses are based on Estimate human exposure (25-Fold Rat/Human) Maximum Tolerated Dose in 90 Day Study Should not exceed 10% decrease in gain Saturation of Exposure Feasibility A dose mid way to provide for Extrapolation Human Therapeutic dose.
- Remember from Module 1, the amount of data that may be available really depends upon where you are in the drug development process. Keep in mind, that in most cases you’re not going to have all the information you need. That’s when you have to rely upon professional judgment and experience. Unfortunately in this field there is “no silver bullet.” For those of you not familiar with that phrase, it’s the expectation that that some new technology or practice will easily cure a major prevailing problem. [It also refers to the myth that only silver bullets would be effective at killing vampires, werewolves, and the like. The Lone Ranger used silver bullets.]
- Our first case is a compounding pharmacy. A small employer with approximately 25 employees. They were handling the compounds shown on the screen. Ask the question, “Does anyone know what a compounding pharmacy is?” Click the green check mark if you do, or the red X if you don’t.They make specialty drugs, prescribed by physicians, for drugs currently not available on the market. An example is Balco.
- In research facilities, there are processes, just harder to define