1.3+1.4
Genentech Inc
Pulmozyme is manufactured by who?
cystic fibrosis
Pulmozyme is used to manage what?
FDA, EPA, USDA
Regulatory guidelines during the production of drugs and cosmetics, chemicals, and crops are written and overseen by agencies such as the...
the company will continue with the development of a product
If the answers to these questions are satisfactory, what happens?
clinical trials
a strict series of tests that evaluate the effectiveness and safety of a medical treatment in humans.
Auriculin
a therapeutic drug developed by Scios, Inc.
therapeutic
an agent that is used to treat diseases or disorders
hypothesis
an educated guess to answer a scientific question; should be testable.
control
an experimental trial added to an experiment to ensure that the experiment was run properly
ABI Prism 310 Genetic Analyzer
an instrument that speeds DNA sequencing and analysis.
clinical trials, FDA
If the product is to become a pharmaceutical, it must undergo ------- under the guidance of the --- before it can be marketed.
257 million
In 2008 Pulmozyme had sales of ...
experimental data not to support a hypothesis or expectation
It is not uncommon for..
too costly to produce
It may be learned early in research and development that a potential product is..
single
Many companies consider it a success to move even a ---- to market in a year.
variable
anything that can vary in an experiment; the independent variable is tested in an experiment to see its effect on dependent variables.
comprehensive product development plan
Many companies develop what for each potential product.
plant products
Monsanto Inc., produces...
market is as quickly as possible
No matter which product(s) a biotechnology company makes, the goal is to...
picture form using graph
Numerical data are shown in ..
data tables
Observations and measurements are reported in...
10 to 15 years
On average it takes about ----- for a company to move a pharmaceutical product through the product pipeline.
ABI Prism 310 Genetic Analyzer
One of the several DNA sequencers and reagest sold by live Technologies Corp.
polymerase chain reaction
PCR stands for
small scale manufacturing
increasingly large volumes of product are made for testing further experimentation.
data
information gathered from experimentation
observation
information or data collected when subject is watched
manufacturing
involves cell culture and product purification
sales and marketing
product is ready for distribution. additional testing for other applications is done
Research and development
researchers develop the techniques to make new products such as genetically engineered proteins
journals
scientific periodicals or magazines in which scientists publish their experimental work, findings, or conclusions
efficacy
the ability to yield a desired result or demonstrate that a product does what it claims to do.
concentration
the amount of a substance as a proportion of another substance; usually how much mass in some amount of volume.
EPA
the federal agency that enforces environmental laws including the use and production of microorganisms, herbicides, pesticides, and genetically modified microorganisms.
FDA
the federal agency that regulates the use and production of food, feed, food additives, veterinary drugs, human drugs, and medical devices.
further experimentation and applications of the findings
A conclusion also suggests ...
"proof of concept" data
A drug must demonstrate .... in the research laboratory before the project moves into the development phase.
REE PEE PA
A good approach for writing an experimental conclusion is to use the .... method.
decreasing the concentration of bleach 50% by diluting it with water will cause the desired lightening of color without causing visible damage to the fabric.
A hypothesis could be that...
Product Identification
A product of interest is identified and evaluated for possible research and manufacturing.
it will be pulled from the pipeline
If a product does not meet criteria what may happen?
clinical development
After products are thoroughly assessed they enter ...
fermentation equipment for large scale production of cell products
Applikon, Inc produces...
two or three
At a give time a smaller company has only ---- products in the pipeline at a time.
ten to fifteen
At a given time a larger company may have ----- in the pipeline at a time.
fade the color in denim, but it will also weaken the fabric and cause holes
Based on experience, full strength bleach will...
therapeutic drugs for several diseases
Bayer Biotech produces...
whether or not it is worth the investment of company resources
Before a product makes it into the pipeline, the company's management reviews it to determine what?
strong oxidizing agent
Bleach is a .... that will fade the colored dye in fabric.
Cystic fibrosis
CF stands for what
data tables, charts, graphs, or graphics
Collect and organize data into...
nearly the same
Companies can specialize in a particular product are because the manufacturing processes and procedure are -------- ----- ------- among similar products.
bioengineered enzymes
Contact lens cleaners, both the solutions and tissues, contain what?
30
Cystic Fibrosis becomes fatal to sufferers of age ....
Environmental protection agency
EPA stands for
similar products
Each biotechnology company usually specializes in a group of ...
nearly seven times, 1990 and 2000
Even with all the government regulations, the number of drugs approved for market increased .... in the 10 years between ...
experimental errors
Experiments are repeated to make sure there are no...
Food and Drug Administration
FDA stands for.
Microsoft Excel
Final copies of data tables and graphs are produced using a spreadsheet program, such as...
Phase III clinical trials with many thousands of patients
For a pharmaceutical, the product must be pass through what included in the testing before an application with the FDA for permission to market the product can be filed.
enzymes for food processing and other industrial applications
Genencor International, Inc. produces...
DNA sequencers for research purposes
Genomyx, Inc. manufactures...
viral therapies
Gilead Sciences Inc. produces...
more color fading
Higher concentrations of bleach should cause...
regular literature reviews, professional meetings
Scientists may envision new products as they conduct their ----- ------- ------ or when they attend ----- ------.
the procedure has been done correctly.
Sometimes a research finds that the hypothesis is just not supported even if..
how to test and the kind of data being collected
The hypothesis implies...
recombinant growth hormone, recombinant human insulin
The protocols for manufacturing ------- ------- ---- are almost identical to those for producing what?
several years
The research and development phase often takes...
driving along a twisty mountain road late one night in northern california
The technique for making billions of copies of DNA in a short time, the polymerase chain reaction, was conceived while a scientist was...
reducing the amount of mucus produced
The use of Pulmozyme improves the quality of life for its patients with CF by...
24
There were only -- new approvals in 2008
United states department of agriculture
U.S.D.A. stands for
previous experiment results
Usually a question or research direction arises from ......, but sometimes a question is based on a new idea.
Product identification, research and development, small scale manufacturing, testing for safety and efficacy, manufacturing, sales and marketing
What are the stages in product development?
Practical applications
What does PA mean?
Possible errors
What does PE mean?
Results with evidence and explanation
What does REE mean?
Auriculin
What drug was pulled from the pipeline when testing showed it was not effective.
What concentration of bleach is best to fade the color out of new denim material in 10 minutes without visible damage to the fabric
What is a good testable scientific question based on the past observation and experience.
Pulmozyme
What is one biotech product enzyme to recently reach the marketplace.
Formulate a conclusion based on experimental data and error analysis
What is step five of the scientific methodology?
Conduct the outlined experiment and collect and organize the data into tables, charts, graphs, or graphics
What is step four of the scientific methodology?
State a testable question or problem based on some information or observation
What is step one of the scientific methodology?
Plan a valid experiment
What is step three of the scientific methodology?
Develop a testable hypothesis
What is step two of the scientific methodology?
GVAZ Prostate
What is the only drug that made it into phase 3 as of 2005?
dialysis free life for patients with diseased kidneys
What was the hope for Auriculin?
quantitative data, multiple replications, a single manipulated variable, and control groups, control group
Whenever possible and appropriate, a valid experiment contains ----------, -----------, ---------, and --------------- - a positive ----------- and a negative -------------.
experimental error or to a hypothesis not being the answer to a scientific question
Why is it that a experimental data does not support a hypothesis or expectation.
testable hypothesis
a ..... ...... is a statement that attempts to answer the scientific question being posed.
reagent
a chemical used in an experiment
Cystic fibrosis
a genetic disorder clogs the respiratory and digestive system with mucus.
negative control
a group of data lacking what is being tested so as to give expected negative results
positive control
a group of data that will give predictable positive results
testing for safety and efficacy
a product is tested to make sure it is safe and effective. if the product is to be pharmaceutical, it must undergo testing called clinical trials.
USDA
the federal agency that regulates the use and production of plants, plant products, plant pests, veterinary supplies and medications, and genetically modified plants and animals
large scale production
the manufacturing of large volumes of a product
five step
usually scientific methodology is presented as a --- ----- process by which researchers ask and answer scientific questions.