SCIE 1P51 Final Flashcards
What is organ printing?
Organ printing is using 3D printing technology to create biomaterials like microstructures or complicated scaffolds
How many functioning 3D printed organs have been successfully created?
none
What does AM stand for?
Additive Manufacturing
What is Additive manufacturing?
A manufacturing technique that produces complex 3D structures by selectively adding materials to create complex biocompatible scaffolds
What are 4 controlled variables in the process of additive manufacturing?
1 shapes of pores
2 pore size
3 distribution of pores
4 connectivity of pores
What is bio-paper?
the printing substrate that the encapsulated cells would adhere to
What is bio-paper made of?
biocompatible ECM-containing hydrogels
How is 3D printing done using bio-paper?
layers are printed one on top of the other and after cells fuse, bio-paper is removed
What 4 ingredients are used in bio-printing?
bio-ink, mixture of cells, growth factors, nutrients
What are 4 parts of the bio-printing process which are currently posing challenges preventing it from being successful?
1 strength and integrity of bio-printed material
2 scaffolds
3 vascular structures
4 printing techniques
Name 3 different printing techniques
1 jet
2 extrusion
3 spin
Name 2 reasons why no functional organs have yet been made through 3D printing
1 difficulty creating blood vessels between tissue layers
2 the specialized functions of many organs are difficult to replicate
What is gene therapy?
Gene therapy is the process by which non-functioning or mutated genes/gene sequences (which are associated with a genetic disease/disorder) are replaced with a normal gene to restore function
What are 3 tools used in gene therapy?
restriction enzymes
plasmids
recombinant DNA
Where are restriction enzymes found?
in bacteria (not found in humans)
What are restriction enzymes used for?
cutting DNA at specific sites to take out a section of the DNA containing what you want (e.g. a specific gene)
What are plasmids?
small, circular pieces of DNA (a string of DNA looped together into a circle)
Name 3 characteristics of plasmids
have replication signal
contain 3 to 5 genes
usually have antibiotic resistance
What is recombinant DNA
new repaired DNA containing your gene of interest
How is recombinant DNA made?
DNA from plasmid and gene are glued back together
What is the purpose of recombinant DNA?
to make proteins
What are vectors (in relation to gene therapy)?
gene delivery systems
What is ‘in vivo’ gene delivery
vector and gene/plasmid are administered directly to organism, and transfers genetic information to live (in vivo) organism cells
Define ex vivo
takes place outside the organism
How many chromosomes are in the mouse genome?
20 chromosomes
At what university was a gene therapy trial done attempting to treat choroideremia (a retinal degenerative disease)?
University of Oxford
When and by whom was the gene therapy trial done attempting to treat choroideremia (a retinal degenerative disease)?
In 2011 by Robert MacLean and coworkers
Choroideremia gene therapy: How was the trial conducted?
6 patients were injected with a gene sequence in the viral vector adenovirus
Choroideremia gene therapy: what were the results of the trial?
2 patients experienced improvement in their vision
Gene Therapy Experiment for Ischemic Heart Failure: what year did the study begin?
2013
Gene Therapy Experiment for Ischemic Heart Failure: what phase is it in?
Phase I
Gene Therapy Experiment for Ischemic Heart Failure: how many patients are included in the study?
17
Gene Therapy Experiment for Ischemic Heart Failure: how is the study conducted?
used a gene sequence to produce protein SDF-1 which can promote the production of stem cells at a specific site
What is haemophilia B?
a sex-linked genetic disease where a person’s body cannot produce clotting factor IX
How is haemophilia B typically treated?
repeated injections of the clotting factor for the patient’s entire life
What is a problem with the typical method of treatment for Haemophilia B?
very expensive
Who conducted the 2011 study “Adenovirus-Associated Virus Vector-Mediated Gene Transfer in Hemophilia B”?
Davidoff and coworkers
How was the Hemophilia study by Davidoff conducted?
Viral vector was used to inject Aden-associated virus into the bloodstream of patients in order to insert the correct gene sequence to produce the clotting factor.
What were the results of Davidoff’s study on hemophilia?
4 patients do not need to continue injecting clotting factor, 2 patients inject less clotting factor, 2 patients experienced mild side effects which were treated successfully
“Treatment of Diabetes and Long-Term Survival Following Insulin and Glucokinase Gene Therapy” - what was this study about?
Four beagles injected with aden-associated virus (AAV) vector and gene sequences to treat diabetes
What animal is Sooam Biotech trying to “recreate” and how?
a woolly mammoth, using blood and skin cells from frozen samples through an elephant surrogate
What were 2 problems with Dolly (the cloned sheep)?
1 lung cancer
2 had arthritis
Why were there problems with Dolly and when was she euthanized?
shortened telomeres caused problems, euthanized age 6 in 2003
How many genes are in the human genome?
over 20,000
What percent of genetic diseases are caused by only one gene?
2% (other 98% caused by a gene combination)
Define homozygous
having identical genes (one from each parent) for a particular characteristic
Define heterozygous
having two different genes for a particular characteristic
Define dominant
the allele of a gene that masks or suppresses the expression of an alternate allele; the trait appears in the heterozygous condition
Define genotype
the genetic makeup of an organism
Define phenotype
the physical appearance
Name 2 different factors in identifying a genetic disease
1 dominant vs recessive
2 sex linked vs autosomal
What are 3 characteristics of a dominant disease?
1 heterozygous (usually)
2 carriers express the disease
3 when one parent is a carrier, risk is 1 in 2
Is sickle cell anemia dominant or recessive?
recessive
What is the shape of a normal cell vs sickle cell?
normal = disc-shaped sickle = sickle-shaped
What is the hardness of a normal cell vs a sickle cell?
normal = soft like a bag of jelly sickle = hard like a piece of wood
How long do normal cells live vs how long sickle cells live
normal = 120 days sickle = 20 days or less
What is one of the problems with the shape of a sickle-cell?
they often get stuck when flowing through small blood vessels
On which chromosome are the genes for sickle-cell anemia located?
chromosome 11
What did Romeo et al find in their test injecting modified human haematopoietic stem cells into mice?
The mice were free of sickle cells 2 to 3 months later
Is Huntington’s disease dominant or recessive?
dominant
What is Huntington’s disease?
a neurological disorder where control is lost of most motor functions
On which chromosome is the gene for Huntington’s disease located?
chromosome 4
Is muscular dystrophy dominant or recessive?
recessive
On which chromosome is the gene for muscular dystrophy located?
X chromosome
1 in how many males are affected by muscular dystrophy?
1 in 3500
What are the effects of muscular dystrophy?
weakness and loss of muscle tissue
Is hemophilia dominant or recessive?
recessive
On which chromosome is the gene for hemophilia located?
X chromosome
1 in how many live male births are affected by muscular dystrophy?
about 1 in 5000
What percentage of hemophilia A patients treated with plasma concentrates in the early 80s experienced negative effects from the treatment? What was this negative effect?
60% became HIV positive
What percentage of hemophilia patients have hemophilia B?
about 25%
1 in how many males have hemophilia A vs B?
A = 1 in 5,000 to 10,000 males B = 1 in 35,000 males
What is pleiotropy? Give examples.
When one gene influences many seemingly unrelated phenotypic traits, e.g. stroke, organ failure, poor circulation, and heart attack
Define polygenic traits, and give examples
Many different genes contributing to one single trait. May be multiple copies of the same gene, e.g. height, skin colour, intelligence
What is Turner syndrome?
A genetic disorder where the only sex chromosome the person possesses is a single X chromosome. Person is female, sterile, and has masculine traits.
What is Klinefelter syndrome?
A genetic disorder where the individual has two X-chromosomes and one Y-chromosome. Person is male, sterile, and has feminine traits.
What is Down syndrome?
A genetic disorder also called trisomy 21 where the individual has 3 copies of chromosome 21.
What factor increases risk of Down syndrome?
Higher age of mother
What is pedigree analysis?
the complex study of human genetics - we study family trees (pedigrees) to identify how traits are inherited.
Name 6 methods of food preservation
1 drying 2 smoking 3 salting 4 freezing 5 concentrating 6 fermenting
What food process had laws surrounding it in Ancient Egypt?
handling of meat
What food processes had laws surrounding it in Ancient Greece and Rome?
diluting of wine, short values on grains and oils
What was the purpose of the 1875 Inland Revenue Act (Canada) in regards to food?
to impose license duties on compounders of spirits and to prevent the adulteration of food, drink, and drugs
What 4 foods did the 1884 Adulteration Act mention?
coffee, tea, pepper, chocolate
In what year was the first standard set for tea in Canada?
1894
In 1920, the Adulteration Act changed its name to what?
the Food and Drugs Act
What was Dr. Harvey Washington Wiley’s profession and where did he work?
Chemist and Chief of the Bureau of Chemistry (which later became the FDA), at Purdue University
What is Dr. Harvey Washington Wiley known as?
the ‘father of pure food’
What was Dr. Harvey Washington Wiley’s ‘poison squad’ and what tests did he perform on them?
a group of local college students in 1902-1904 that he fed meals with some problematic additives, testing their bodily fluids for toxicity
When was the first patent made for a food additive?
1886
In was year was the FDA formed?
1906
What is a food additive defined as in Canada?
any substances, including any source of radiation, the use of which results in, or may reasonably be expected to result in, it or its byproducts becoming a part of, or affecting the characteristic of a food
What is a food additive defined as is the US?
In general, anything intentionally added to a food to produce a specific beneficial result
What does GRAS stand for?
Generally Recognized As Safe
How were older GRAS compounds added to the list?
“common experience” or the “nothing happened” test, aka no laboratory
How are new GRAS compounds certified?
A manufacturer can apply to have their additive receive GRAS status. Scientific studies done to show compound safety
What does GMP stand for?
Good Manufacturing Practice
what is the purpose of the GMP
to dictate that the minimum amount of the food additive required to achieve the desired technical effect may be used and no more
What are 3 sources of food additives?
1 natural
2 synthetic version of natural compounds
3 synthetic artificial new compounds not found in nature (synthesized in a lab)
What are 12 functions of food additives?
flavours preservatives flavour enhancers colours sweeteners thickeners/emulsifiers acidulants anti-caking agents humectants bleaching agents leavening agents nutritional agents
Name 3 types of preservatives
antioxidants
antimicrobials/anti-fungals
sequesterants
What is the function of antioxidants? give examples.
to prevent oxidation of fats and oils, and to stop or delay rancidity, e.g. BHA, BHT
What is the function of antimicrobials/anti-fungals? give examples.
to prevent microbe/fungal activity, e.g. vitamin C, sodium benzoate, calcium propionate
What is the function of sequesterants? give examples.
chemicals that react with any metal ions in food and create “chelates” or compounds with metals, e.g. citric acid, ammonium citrate, disodium EDTA
In 1958, what did James Delaney declare about food additives?
no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal or if it is found, after tests which are appropriate for the the evaluation of food additives
What are the two types of sweeteners?
natural and artificial
Give 3 examples of natural sweeteners
corn syrup dextrose glucose invert sugar lactose
Give 2 examples of artificial sweeteners
aspartame
sucralose
How high are aspartame and sucralose on the sweetness scale?
aspartame - 200
sucralose - 600
Who conducted a clinical trial to find a treatment for scurvy?
James Lind
How did James Lind conduct his study on scurvy?
he selected 12 sailors suffering from scurvy
divided into 6 groups of 2
group 1 - drank 1 litre of cider daily
group 2 - 25 drops of vitriol (sulphuric acid) 3 times a day
group 3 - 2 spoons of vinegar daily
group 4 - 177 mL of sea water
group 5 - small size of a mixture containing garlic, mustard seed, radish, balsam of Peru, and gum myrrh once daily
group 6 - 2 oranges & 1 lemon
What were the results of Lind’s study on scurvy?
he found that the group eating 2 oranges and 1 lemon daily was healing within about 5 days; the other treatments were not as effective
In 1947, what recent event had caused the push for regulation for the protection of clinical trials volunteers?
The Nuremberg Trials during WWII
What were the Nuremberg trials?
more than 30 different experiments described at the trials.
concentration camp victims - men, women, and children were tested on
What 5 different types of experiments did the Nazis conduct on prisoners?
high altitude or low pressure experiments freezing malaria phosphorus burn seawater
What 10 regulations does the Nuremberg Code (of conduct) outline?
- voluntary consent is absolutely essential
- experiment should yield useful results, unobtainable by other methods
- based on animal experimentation
- avoidance of unnecessary physical or mental suffering and injury
- death or disabling injury should not be expected outcomes
- degree of risk should not exceed expected importance
- protection against injury, disability, death
- scientifically qualified persons
- subject may withdraw from experiment at any time
- discontinuation of experiments is likely to result in injury, disability, or death
What was the Declaration of Helsinki? Describe it in 3 points.
The civil counterpart to Nuremberg, it:
1 extended burden of care to those conducting the trial
2 referred to people as patients, not subjects
3 differentiated between therapeutic and non-therapeutic research
What was the Beecher Article NEJM (1966) about?
A study done of 22 published medical studies which presented risk to test subjects without their knowledge or approval
Who were the test subjects in the Tuskegee Syphilis Study and how many were there?
Syphilitic African-American men, 400 were tested, plus 200 uninfected control subjects
In exchange for free burial, free “medical care”, food, and transportation to and from clinics, what did the study participants give the study permission to do?
autopsy after death, access to their blood samples, and their participation in ‘various’ medical tests
What were 2 problems with the Tuskegee Syphilis Study?
Subjects were actively discouraged from obtaining separate treatment (they would be disqualified from the trial if they did)
There was also deception about the treatments
What types of treatments were given to participants in the Tuskegee Syphilis Study?
iron and aspirin spinal taps (an extremely painful procedure)
What were 3 problems with the Tuskegee Syphilis Study?
1 Subjects were actively discouraged from obtaining separate treatment (they would be disqualified from the trial if they did)
2 There was also deception about the treatments
3 subjects were prevented from obtaining penicillin as treatment when it became available in 1943
What was the result of the Tuskegee Syphilis Study?
By 1972, most patients had died either directly from syphilis or complications associated with the disease. 40 wives were infected and 19 children were born with complications.
What was the 1979 Belmont Report?
a summary of basic ethical principles designed to clear up any confusion with regard to research involving human subjects
What were the 3 basic ethical principles outlined in the Belmont Report?
- respect of persons: treatment of person as autonomous
- beneficence: Issue re: potential conflict between good of society vs. individual
- justice: treatment of all fairly and all equally share benefits and risks
What is a clinical trial
a prospective study comparing the effect and value of intervention(s) against a controlling human subjects
How long does it take to test a new pharmaceutical drug?
about 12 years
What happens during phase 1 of a drug trial
- 50 - 80 subjects
- safety
- MTD - maximum tolerable dose
- Pharmacokinetics - study of the absorption, distribution, metabolism, and elimination of drugs (ADME)
- healthy subjects or may include subject with known conditions
- interaction studies - food, other medications
- 1 year
- 5 compounds enter trial
What happens during phase 2 of a drug trial
100 - 300 subjects short term effectiveness 2 years 5 compounds enter trial trials use subjects with specific target disease
What happens during phase 3 of a drug trial
1000 - 3000 patients
verify & long-term
3 years
3-5 compounds enter trial
What happens in phase 4 of a drug trial
long term surveillance
Health Canada/FDA
2.5 years
1 compound approved
What happens during phase 5 of a drug trial
further trials & monitoring
1 compound approved
What are the 3 methods of naming a drug
chemical name
nonproprietary (generic) name
proprietary (brand/trade) name
Who studied/discovered the placebo effect
Irving Kirsch
How did Irving Kirsch test using a placebo?
gave a placebo to people on Prozac
What were Irving Kirsch’s findings on using a placebo for Prozac?
some symptoms were alleviated
- feeling well
- more energy
- less distraction/more focus
- however, some experienced nocebo effect
Name 5 study methods to eliminate the nocebo effect
1 double blind study 2 randomized selection 3 crossover study 4 positive control study 5 factorial study
What is a crossover study
for half of the trial you are on the placebo and for half you are on the drug, but you do not know when you are on which (ideally, but some can tell the difference)
What takes place in a positive control study
group 1 on standard treatment
group 2 on new treatment
What is a factorial study
4 groups:
- one takes treatment A
- one takes treatment B
- one takes both
- one takes neither
What was thalidomide originally tested as in 1956?
a sleeping pill
What were the results of the use of thalidomide?
more than 12,000 infants deformed due to drug
40% died within a year of birth
5,000 survivors today
New uses of thalidomide?
leprosy, cancer, AIDS
What does sunscreen protect from?
ozone layer
ultraviolet radiation
What are active ingredients included in sunscreen to block and reflect?
zinc oxide
titanium dioxide
What are active ingredients included in sunscreen to absorb radiation?
PABA
benzophenones
dibenzoylmethanes (parasol)
How many skin types are there?
6
Which skin types are usually tested on?
1 & 2:
skin type I - always burns easily: never tans
skin type II - always burns easily: tans minimally
How are sunscreens usually tested?
Using UV exposure on hairless mice, then human subjects are given an MED (minimal erythemal dose) on patches of skin on the back or arm
What is an MED (minimal erythemal dose)
the smallest amount of radiation (expressed as joules per metre squared) that produces redness reaching the borders of the exposure site
Name 2 misconceptions about sunscreen
that it will completely prevent sunburn
that it will prevent cancer
When skin is exposed to the sun with no protection, how long until UVA and UVB induce cell apoptosis and necrosis?
19 minutes
What are Bioprints?
Using 3D printing technology to create biomaterials and microstructure or complicated structure
What is Additive Manufacturing (AM)?
A technique that produces complex 3D structured by selectively adding materials to create complex biocompatable scafolds
What are the main challenges that prevent bioprinting a functioning organ?
- inability to create blood vessels between tissues
- integrity of bioprinted material
- simulated multifunctional specialized organs
What was the first ever successful gene therapy experiment?
Sever Combined Immuno-Deficiency - using mouse retrovirus to deliver it (1990)
Name 4 additives that are preservatives?
Antioxidants
Antimicrobials
Sequestriants
Anti-Fungals
What problems were found with the gene therapy experiment in 1999?
The death of Jesse Gelslinger becasue:
- experiment continued despite adverse events in primates
- experiment continued despite edverse events in 2 previous human subjects
- patients did not receive proper informed consent
- conflict of interest of the principal investigator
What new regulations were instigated after the problems with the 1999 gene therapy experiment?
- the gene must be clonable
- there most be an efficient transfer mechanism
- minimal risk to subjects
- only if no other treatment is available
- preliminary mice and human trials were successful
What was the name of the primate who was first inserted with DNA?
ANDi - with jelly fish green florescent DNA (GFP) that did not function despite a successful transfer
(later successfully functioning GFP was inserted in marmosets and effectively transferred to offspring)
What was the gene therapy done on squirrel monkeys?
Colourblindness (2009 study successful)
What is Choreideremia?
A progressive retinal disorder affecting males and causing night blindness and progressive lose of peripheral
What occurred in the 2011 trial done for Choreideremia?
- 6 patients were injected with gene sequence
- two patients experienced improved vision
What are the 4 main types of cloning?
1 Molecular Cloning
2 Cellular Cloning
3 Embryo Twinning
4 Somatic Cell Nuclear Transfer
What is Molecular Cloning?
Making copies of single molecules
What is Cellular Cloning?
Making copies of cells to establish cell lines
Used to make human tissue (heart, skin etc)
What is Embryo Twinning?
Using a fertilized egg separated into individual cells re-implanted in to a host resulting in identical animals without host DNA involvment
What is SCNT?
Somatic Cell Nuclear Transfer
Removing nucleus from host cells and removing nucleus from unfertilized egg then, inserting somatic cell nucleus into egg and electrocuting to simulate fertilization before implanting
Coined term ‘Clone’?
Derived from Greek ‘Klon’ meaning twig or slip
What was the first successful SCNT cloning?
1997- Dolly (sheep) using the adult mammary cell of an Ewe
When was the first successful cat cloned?
2001 (Dec) -named CC (copy cat)
When was the first cloning of a rat?
2003- Ralph
When was the first cloning of a horse?
2003
When was the first cloning of a dog?
2005 -snuppy
What does it mean when an additive is Regulated?
Countries follow FAO/WHO regulated or restricted use of additives
Name the additives that are preservatives?
Antioxidants
Antimicrobials
Sequestriants
Anti-Fungals
What is the function of an Antimicrobial additive?
Prevent microbe/fungal activity
What are examples of Antimicrobials?
Sodium Benzoate
Calcium Propionate
What is the function of a Sequestriant?
Chemicals which react with any metal ions in food and create compounds with metal
What are examples of Sequestriants?
- Citric Acid
- Disdodium EDTA
What are examples of flavour enhancers?
MSG- mono sodium glutonate
HVP- hydrolyzed vegetable protein
What was stated in the 1960 Additives Amendment to FDCA?
- required FDA approval of dyes before manufacturing
- required testing of safety of existing dyes
What is the function of an Emulsifier?
Participate in the thickening of foods
What are examples of Emulsifiers?
- Gums from seeds/nuts
- seaweeds
- fruits
- plant cells
- starches
Examples of Acidulants?
Citric acid (most common) Acetic acid Phosphoric acid (used in coke)
What are the functions of Anti-Caking agents?
keep foods free flowing and stop particles from sticking together
What is the function of a Humectant?
Keep moisture in food - prevent drying out?
Examples of Humectants?
- Honey
- Glycerol
What is the function of nutrients supplement additives?
- restore nutrition lost in processing or in storage
- ensure nutritional value not provided in nature
Examples of Leavening agents?
Sodium Aluminium Phosphate
Ammonium hydrogen carbonate
What purpose to fat additives serve?
- mouthfeel
- flavour carrier
- carrier for fat soluble vitamins
What is the purpose of Trans and Hydrogenerated fats?
lengthen shelf life
What are Trans Fats linked to?
Coronary Heart Disease
What are the Trans Fat limits?
- 2% content for vegetable oils and spreadable margarins
- 5% content in all other foods
What does ADI stand for and what does it mean?
Acceptable Daily Intake:
The amount of a food additive, expressed on a body weight basis, that can be ingested daily over a lifetime without health risk
What is food irradiation?
The process of exposing food to controlled levels of ionized radiation to kill harmful bacteria, pests. or parasites (or to preserve freshness)
What is the nickname for food irradiation?
‘Cold Pasteurization’ because it kills harmful bacteria without heat
Name the three types of Radiation?
Alpha Radiation
Beta Radiation
Gamma Radiation
Describe Alpha Radiation?
- weakest radiation level
- cannot penetrate skin (would be stopped by a piece of paper)
Describe Beta Radiation?
- middle radiation level
- can penetrate the skin, but not deeply (stopped by plastic or metal)
Describe Gamma Radiation?
-stronger radiation level
-penetrates everything
Most commonly used for food
What year was food irradiation first suggested?
1895
What year was food irradiation WHO approved?
1980 (previously used for sterilization regularly in military)
Where is the radiation derived from?
Cobalt
What does food irradiation prevent?
- root formation
- spoilage
- pests
What other then food receives similar irradiation?
- baby bottle nipples
- bandages
- Medical gowns/gloves
- feminine hygiene products
Describe a Low Dose of Gamma Radiation
- 1 kGy
- used on imported food stuff
- prevents: Sprouts, ripening bugs
Describe a Medium Dose of Gamma Radiation
1-10 kGy
- used on grains, spices and ground meat
- Prevents: spoilage, pathogens and ripening
Describe a High Dose of Gamma Radiation?
10-50 kGy
- used on space equipment, and medical equipment
- purpose of sterilization
What foods are regularly irradiated in Canada?
- potatoes
- wheat, flour
- onions
- spices
- dehydrated seasonings
What foods are proposed to be irradiated in Canada?
- Ground Beef
- Poultry
- Shrimps, pawns
- Mangoes
What are concerns regarding increased use of irradiation?
- workers (safety concerns)
- possibility of a nuclear accident
- nuclear waste (however, cobalt can be re-radiated eliminating waste)
First Pharmaceutical Trial Scurvy: how many sailors were selected?
12 divided into 6 groups of 2 sailors
First Pharmaceutical Trial Scurvy: how were the sailors treated?
Each group received a different treatment (trial and error approach)
First Pharmaceutical Trial Scurvy: how were the sailors treated?
Each group received a different treatment (trial and error approach)
What is a clinical trial by definition?
A prospective study comparing the effect and value of interventions against a control in human subjects
Clinical Trials: What is the typical timeframe for a hypothesis to be thought to the time of its approval and selling?
approximately 12 years
Clinical Trials: Describe Phase 1 Testing?
- 50-80 patients (1 year)
- researching safety (MTD) (food/other medication interaction)
- most often done on healthy subjects
- 5 compounds enter phasing
Clinical Trials: Describe Phase 2 Testing?
100-300 patients (2 years)
- researching short term effectiveness
- use subjects with specific target disease
- 5 compounds enter phasing
Define Pharacokeneticts?
The study of the absorptions, distribution, metabolism and elimination of drugs
Clinical Trials: Describe Phase 3 Testing?
1000-3000 patients (3yrs)
- verify effectiveness and researching long term
- 3-5 drugs enter phasing
Clinical Trial: Describe Phase 4 of Testing?
- long term surveillance (2-5 years)
- (Health Canada and FDA)
- 1 compound approve
Clinical Trials: Describe Phase 5?
- further trials and monitoring
- 1 compound
Clinical Trials: Describe Phase 5?
- further trials and monitoring
- 1 compound
Who were the researchers of The Definition of Placebo in the Informed Consent Forms of Clinical Trials (2014) article?
Hernández et al
The Definition of Placebo in the Informed Consent Forms of Clinical Trials (2014): What were the researchers questioning?
Whether or not patients were receiving the proper amount of information about placebos on their consent forms
The Definition of Placebo in the Informed Consent Forms of Clinical Trials (2014): How were protocols analyzed and from what period of time did researchers take trial protocols from?
Three researchers read each explanation of the term placebo: 2007-2013
The Definition of Placebo in the Informed Consent Forms of Clinical Trials (2014): How many studies provided subjects with details about the placebo effect?
None of the studies provided details about the placebo effect.
-23 lacked any information about placebo at all.
The Definition of Placebo in the Informed Consent Forms of Clinical Trials (2014): What was the conclusion of the study?
There is a lack of information about placebos in informed consent forms and information about the placebo effect and associated risks are absent.
The Definition of Placebo in the Informed Consent Forms of Clinical Trials (2014): Which medical fields had the majority in trials involving placebos?
Oncology (15.0%)
cardiology (14.2%)
neurology (13.1%)
The Definition of Placebo in the Informed Consent Forms of Clinical Trials (2014): In most cases, how was the term Placebo defined in the various trials?
Similarly short - between four and eight words, not very informative
The Definition of Placebo in the Informed Consent Forms of Clinical Trials (2014): What is an ICF?
Informed Consent Form
Placebo Reading: What does Analgesic mean?
A painkiller…..used to relieve pain
Placebo Reading: What is the Nocebo effect?
When a patient experiences negative events after being treated with a placebo (opposite of the placebo effect)
3D Printing Reading: What is an Autograft vs. an Allograft
Autograft: Tissue transported from one area to another of a single individual
Allograft: Transported from one person to another (organ transplant)
3D Printing Reading:What is a Collagen?
Most abundant protein in the human body - used as various connective tissue
3D Printing Reading: Osteoconductive
When the graft material acts as a scaffold for bone growth and regeneration
3D Printing Reading: Osteoinductive
Involves the stimulation and then beginning of new bone formation
3D Printing Reading: Proliferation
The growth, or multiplication of cells
3D Printing Reading: Cyto-compatibility/toxicity
Whether or not cells are ‘getting along’ ;)
3D Printing Reading: Osteotomy
The surgical cutting or removal of a bone
3D Printing Reading: Ex vivo/in vivo
studying in an external environment/internal environment
3D Printing Reading: Anisotropic
The property of being directionally dependent
3D Printing: Tween-80
A non-cytotoxic surfactant, was added to some of the binder formulations to improve printing function
3D Printing: What does CPS stand for?
Calcium Phosphate Scaffolds
