ERHS 568 Pharmaceu/Regulatory Toxicology Test 1
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What are the basic steps of drug development?
- 1. Discovery
- 2. Formulation
- 3. Product Development
- 4. Pre-Clinical Research
- 5. Clinical Trials
What is the average time and $ to bring a drug from discovery to market?
"in vitro tests" as they relate to drug research?
In vitro tests are usually the exclusive test type used during early drug discovery.
When are animal and micro-organisms used drug development?
During the Pre-Clinical phase.
When are Safety and Toxicity screening done during drug development?
During the Pre-Clinical Phase.
What needs to be done during the Pre-clinical Phase of drug development?
- 1. Animal and Microorganism tests
- 2. Safety and Toxicity screens.
Describe the components of an effective Toxicity study:
- 1. Acute Toxicity
- 2. Subacute (chronic) Toxicity
- 3. Carcinogenicity
- 4. Minimal Lethal Dose
- 5. No Effect Dose
What would be important to find in a safety study?
How big the gap is between the ED50 and the LD50.
Describe an Acute Toxicity Study:
- Measuring up to a Lethal Level:
- 2 routes of exposure,
- 2 species,
- 1 single dose.
Describe a Subacute (chronic) toxicity study:
Checking Multiple doses, (vs the single dose in an acute tox study).
Describe a "SAFE" drug:
it's basically a drug where the ED curve and the LD curve do not overlap at all.
What are some limitations to the Pre-clinical phase of Drug Development:
- 1. Time Consuming and Expensive.
- 2. Lots of Animal Samples are Needed.
- 3. Animal to Human extrapolation is hard to predict.
- 4. While in-vitro is being used, it limits the effectiveness of the study vs. animal studies.
Who are some Pre-clinical governing bodies?
- 1. IACUC
- 2. AAAIAC
- 3. NIH: OLAW
Describe IACUC: (very basic)
- 1. 3+ members: Scientist, Vet, Non Affiliate Community Member.
- 2. Facility Inspection every 6 months.
- 3. IACUC must approve protocol before pre-clinical study can begin.
Briefly describe AAAIAC:
- Very strict organization.
- Their standards exceed IACUC.
- It is a voluntary certification.
Who publishes "The Guide"?
What is the full title?
- 1. NIH: OLAW
- 2. The Guide to Animal Care and Use.
What is a CRO?
- A Contracted Research Organization.
- Most notable were the problems CRO assurance provided during the 1960&70's
With the boom of drug development of the 60's and 70's, what happened.
Increase of drugs development led to an increase in the safety testing needed. This led to an increased use of CRO's to fill this need.
Descibe what happened with IBT
- 76- the FDA inspected IBT (35-40% of all tox(safety) studies done in the US were done by this company).
- Largest Scientific Fraud ever!
- Design Flaws,
- Complete Dry Lab Studies!!
- Bad conditions
- Analysis of analytical results were never performed.
What did the IBT findings do?
- Prompted FDA to form better controls from planning to submission.
- Published regs on GLP
Why did the FDA publish Title 21? (Regs on GLP?)
- To promote quality and validity of test data.
- helping results to be: reliable, repeatable, & recognized by science community.
What do GLPs not do?
Assess intrinsic scientific value of a study.
What governments adopted GLP in 86?
What if one GLP government wants to accept a study done by another GLP government?
Through the Organizatinon for Economic Cooperation and Development (OECD) they do not need to repeat GLP studies for individual certification.
What are the 3 Rs of GLP studies?
- 1. Reduction
- 2. Replacement
- 3. Refinement
5 check points to be GLP Certified?
- 1. Resources
- 2. Rules (procedures & protocols)
- 3. Characterization of test compounds
- 4. Documentation
- 5. Quality
What are Important RESOURCES?
- Study Director
- Quality assurance
- Facilities & Equiptment
Things to consider with Lab areas
- Are they separate?
- Cross Contamination?
Things to consider with test systems:
- Are they separate?
- Are individual projects, species, genomes separate?
What about the Drug?
Do we have DEA License and registration if it's a controlled drug?
What about our archived files?
- Are they preserved and protected from the environment?
- For how long?
How good is our science?
- Based on previous accepted procedures (precedent?)
- Experimental Design (is it solid?)
What about our organization
- How is the "Flow" in our facility?
- Staff Trained?
- what about resource allocation?
- Record Keeping?
Who keeps the Master Schedule?
And What is on the MS?
- Study Director.
- Schedule of All studies performed at facility
What about Documentation?
- If it's not documented, it didn't happen.
- Raw, Final, Archived data.
What does the FDA expect the sponsor will develop and determine at the preclinical stage?
- Pharm Profile
- acute tox
- 2 species of animals (rodent and non rodent)
- short term tox studies.
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