Use of a lawfully marketed drug for an unapproved use in the course of medical practice is not a clinical investigation and does not require an IND

Answers

Answer 1

Use of a lawfully marketed drug for an unapproved use within the course of medical practice is not a clinical investigation and does not require an IND because it involves the employment in a personal patient wherever the first intent is to treat the patient.

An Investigational New Drug Application (IND) could be a request from a clinical study sponsor to get authorization from the Food ANd Drug Administration (FDA) to administer an investigational drug or biological product to humans.

The bulk of IND are filed for non-commercial analysis and are of 3 main sorts - (1) Investigator IND, (2) Emergency Use IND, and (3) Treatment (Compassionate Use) IND.

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Related Questions

Going to the pharmacy is "easy" for those of us who can see and hear. What do you think would be barriers and safety implications for those who are challenged in seeing and hearing?

Think of when you go to the pharmacy and the steps you need to take when picking up a prescription. Keep in mind every single step and possible places where confusion could occur for the seeing and hearing impaired.

Do you think going to the pharmacy will be easier now for you that you understand medical terms?

Answers

Answer:

For the blind it would be difficult to know whether the prescription they are getting is correct. Though they have the advantage of verbal communication, if there is any mistake on the amount or type of medication they have asked for it would be impossible to know unless there was someone else there with them.

For the deaf the language barrier becomes a problem as they often cannot communicate verbally and the pharmacists may not know sign language. This can become frustrating for both parties when they aren't being understood. You cannot ask for a medication if you cannot describe your pain to the pharmacist unless you already have a prescription.

Explanation:

According to the Dietary Guidelines for Americans, which of the following

Answers

the answer would be C fruits

IF YOU PLAY BASKETBALL HELP ME PLEASE AND AWNSER THESE QUSTIONS

Answers

Answer:

There are 5 positions in basketball. They include being the center, power forward, small forward, point guard, and shooting guard.

To identify how a point is worth 2 points, the shot has to be inside the big circle surrounding each hoop. For 3 points, it has to be outside the circle.

1. Blocking foul: If the defender does not get into a legal guarding position before contact occurs, it is a blocking foul on the defender. If he gets to a legal guarding position before contact occurs, it is an offensive foul.

2. A charging foul occurs when an offensive player makes significant contact with a defensive player who has established their position with both feet on the ground and their torso square facing the opponent.

3. A flagrant foul is if unnecessary and/or excessive contact occurs.

4. A personal foul committed by the offensive team during a throw-in shall be an offensive foul, regardless of whether the ball has been released. Contact which occurs on the hand of the offensive player, while that part of the hand is in contact with the ball, is legal. EXCEPTION: Flagrant and punching fouls.

5. A defensive foul in basketball is a foul committed by a defensive player. There are three main types of fouls: personal, technical, and flagrant fouls. Any of these fouls can be committed by a player on defense, but the term “defensive foul” is usually reserved for personal fouls by a player on defense.

6. Any player whose actions against an opponent cause illegal contact with yet another opponent has committed the personal foul. A personal foul committed by the offensive team during a throw-in shall be an offensive foul, regardless of whether the ball has been released.

7. A technical foul(s) may be assessed to any player on the court or anyone seated on the bench for conduct which, in the opinion of an official, is detrimental to the game. The technical foul must be charged to an individual. A technical foul cannot be assessed for physical contact when the ball is alive.

Explanation:

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Which of the following would NOT cause unreliable pulse oximetry readings?
Colored ac
ic nails

Answers

Which of the following will not cause pulse oximetry artifact (more than one response may be correct): (1) fetal hemoglobin; (2) Hgb < 7 g/100 mL

Fetal hemoglobin and bilirubin do not cause pulse oximetry artifacts. The correct option is 1.

What is pulse oximetry?

Pulse oximetry is a test that measures the amount of oxygen in the blood (oxygen saturation).

It is a simple, painless test that determines how well oxygen is delivered to parts of your body farthest from your heart, such as your arms and legs.

When the lungs' ability to transport oxygen into the blood is compromised, blood oxygen saturation falls, potentially putting our organs in danger.

A pulse oximeter can detect this drop in oxygen saturation quickly, alerting people to the need for medical help.

Systolic arterial blood pressure can be measured using pulse oximetry. Pulse oximetry artifacts are not caused by fetal hemoglobin or bilirubin.

Thus, the correct option is 1.

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Your question seems incomplete, the missing options are:

(1) fetal hemoglobin;

(2) Hgb < 7 g/100 mL;

(3) bilirubin;

(4) carboxyhemoglobin;

(5) methemoglobin;

Name the 3 parts of the lungs that air travels through to fill the lobes. List them from biggest to smallest.

Answers

the right upper lobe (RUL), the right middle lobe (RML), and the right lower lobe (RLL).

All of the following statements are true of word parts, EXCEPT:

A. a backslash is used between the word root and combining vowel.

B. Prefixes usually indicate location, time, number or status.

C. Word roots contain the basic meaning.

D. Four different word parts are always used in every medical term.​

Answers

All of the following statements are true of word parts, except , Four different word parts are always used in every medical term .

What is accurate about a word's root?

The foundation of a word is called a word root (i.e., less any prefixes and suffixes).The meaning of a word can be altered by adding a prefix or a suffix to the front or back of the word root. Prefixes and suffixes are frequently used to modify the meaning of word roots.

Does "doctor" have a root?

The Latin verb docere, which means "to instruct," is the origin of the term doctor and also unexpectedly appears in the roots of the words "docile" and "document," both of which you initially drew the word "doc" from.

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The definition of food needed by humans and animals is

Answers

The definition of food needed by humans and animals is the nutritional support needed by the body in order to perform activities. Food is the energy source.

What is the source of food ?

Food depends on the plants primarily and these are the primary producers of the planet.

Therefore, food is the energy source and required for the nutritional support of any living being.

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Health science, match the terms with the appropriate definition

Answers

Because it’s really ez to do and better and
Health is a state of complete physical mental and social well being. Its not only the absence of disease. ​ A person is said to be healthy when he/she is free of any type of disease (infectious/deficiency), when he/she is mentally happy and healthy and when his/her social relationships are healthy in a society.

genuine question, what mental disorder would be classifed?


you have a best friend you know them for a year to find out everything was just in ur head and none of it was even real

Answers

Answer:

Explanation:

Illness Anxiety Disorder (Hypochondria, Hypochondriasis)

for brainest

someone explain what happens when you die or how you are going to feel like when you die and why you shouldn't be afraid of death

most logical answer gets brainest​

Answers

The brain does not know what happens after death

But when you die you will have a flash back of all your memories before your brain completely dies

Explanation:

hmmm this question, well no one would actually know the answer

It is often assumed that you will see a bright light flash when you die signaling maybe the entrance to somewhere further beyond the physical world

There is also newton's law stating that energy cannot be made nor destroyed only converted from one form to the other: from this people can be seen as a form of energy, our body and soul, Everything in its entirety, so when we die our energy is not lost just converted, the physical body is not longer capable to hold the energy of the soul so it leaves and some people believe that is where the soul goes into the afterlife.

because of this same reason this is why many people believe in karma, and rebirth.

you shouldn't be afraid of death, it's inevitable, but actually what people fear is not death, it's loneliness and fear of the unknown cuz that's just it, we don't know

Also I think at the point of death, one will feel nothing because that is when their soul can completely remove itself from all ties to its body furthermore all its senses.

Part C
Why does Congress want the FDA to regulate UVA labeling as well?

Answers

Answer: Heart Outlined!

Explanation:

Answer: Congress wants the FDA to regulate UVA labeling because UVA rays also cause cancer.

Explanation: edmentum answer

Which best practice incorporates using respectful workplace courtesy? (5 points)
O Greeting a patient when they come to the desk
Holding a door open as a patient enters the room
Seeing a patient as quickly as possible but limiting your time with them
Keeping eye contact with the patient whenever you are talking to them

Answers

Answer:

Always give eye contact

Explanation:

Enter Nathan's pulse, along with the site, it was taken and a description (rhythm/depth).

Answers

It should be noted that Nathans's pulse given the reading below is 72 beats per minute.

What is a pulse?

A pulse in medicine is the tactile arterial palpation of the cardiac cycle by skilled fingertips. The pulse can be palpated anywhere an artery can be constricted near the body's surface, such as the neck, wrist, and groin, behind the knee, around the ankle joint, and on the foot.

To arrive at the above pulse, we must multiply the pulse reading by 4.
Rationale: There are 60 seconds in one minute.

Since pulse measurements are given in minutes,

and there are 18 beats in 15 seconds,

Pulse Per Minutes = (60/15) x 18

Pulse Per Minute  = 4 x 18

Pulse Per Minutes = 72

That is:

72 beats per minute.

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Full Question:

Enter Vitals

Signs: Pulse

Now, you measure Nathan's pulse on his wrist. It is 18 beats over 15 seconds with a regular rate and bounding depth

2. Enter Nathan's pulse, along with the site it was taken and a description (rhythm/depth).


To lose FAT you need to eat a diet of
and
carbs, that is high in
, and low in

Answers

You need to eat a diet low in carbohydrates and high in protein and vegetables

To lose FAT you need to eat a diet of healthy fats and carbs, that is high in fats, and low in carbohydrates.

Healthy fats are beneficial for the body. They do not cause mass gain to the body and also trigger the stored body fats to breakdown and release energy, therefore helping in fat loss. The foods rich in healthy fats are: avocados, cheese, fishes, nuts, beans, eggs, etc.

Carbohydrates are the biomolecules that are hydrates of aldehydes and ketones. They are of three types: monosaccharides, disaccharides and polysaccharides. Excessive intake of carbohydrates in food, cause its conversion into stored fats inside the body, leading to health problems.

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What has OSHA done for the workplace? What improvements have been made to the workplace as a results of OSHA compliance? What are your thoughts on the existence of OSHA in the workplace?

Answers

The thing that OSHA done for the workplace is that it has provided safe and healthy working conditions for both men and women by establishing and enforcing standards as well as by offering outreach, education, and aid with compliance

The improvements because of OSHA compliance are  workplace fatalities have decreased by 50% and work-related illnesses and injuries have decreased by 40%.

My  thoughts on the existence of OSHA  is that Your staff can work safely if you adhere to OSHA regulations.

What is OSHA's role?

You have a right to a safe workplace under federal law. Your workplace must be free of all known health and safety risks, according to your employer.

Note that OSHA establishes health and safety requirements for a range of professions. These professions could be in the construction industry, healthcare, maritime operations, etc. OSHA does more than just establish workplace regulations; it also educates employers on worker health and safety.

Therefore,  Employers are required by OSHA legislation to provide a secure and healthy working environment for their employees.

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100 POINTS!!!!!!!!Overview:

In this unit of the course, you learned about the different roles in the Healthcare industry, medical terminology, and the responsibilities and skills required for the workplace. Take a moment to review the skills and knowledge identified by the Health Science and Medical Technology Curriculum Standards to be prepared for the fundamentals of a career in the field of Patient Care.

Describe the various roles and responsibilities of health care workers as team members in an integrated health care delivery system.

1. Know relationship and use of an integrated health care delivery system.
2. Plan basic care procedures within the scope of practice to assist with patient comfort.
3. Know the definition, spelling, pronunciation, and use of appropriate terminology in the health care setting.
4. Use medical terminology in patient care appropriate to communicate information and observations.
5. Know the basic structure of medical terms.



Portfolio Assignment #1

In three or more paragraphs reflect on at least two of the topics you have completed in this unit. Describe each topic and explain which fundamental skills (listed above) you have met by completing this activity. In your concluding paragraph, reflect on how learning this material and completing the activities will help you in a career within the Healthcare industry.

Make sure your reflection assignment is typed (12-point font, Times New Roman) and saved somewhere you can easily access it for the final portfolio project at the end of Nursing Assistant 2.

See rubric on next page for how you will be evaluated for this assignment

Answers

Answer:3

Explanation:

According to a 2013 survey, _______ of those surveyed showed a negative bias toward the LGBT community

Answers

Answer:

hmmmnnn...I'm not sure this is an actual question..I guess it's just to see people's reactions and answers

According to a 2013 survey reactions of those surveyed showed a negative bias toward the LGBT community.

What is LGBT community?

The adaptation of the laws was significantly delayed with respect to sociocultural development. The equalization of homosexuals was part and consequence of a liberalization of respect to cultural traditions, which have been losing importance during the twentieth century and that gave way to the concept of individual maturity freedom.

The headline that comes out from television, newspaper and other headline news that is clearly communicating dull and negative bias towards the president of united states is that President kills bipartisan tax reform bill whom others believe that it will truly benefit middle-class Americans.

Therefore, According to a 2013 survey reactions of those surveyed showed a negative bias toward the LGBT community.

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If sexual
battery has
been
committed
on a 10 year
old, is it
necessary to
prove that
force was
involved in
order for it
to be
classified as
First Degree
Sexual
Misconduct?

Answers

Answer:

Explanation:

id sure hope so Jesus

What should you do if you get caught in a current?
A.
Float on your back
B.
Float on your stomach
C.
Swim against it
D.
None of the above

Answers

A! I hope the rest of the assignment goes well! :)

Answer:

A. Float on your back

Explanation:

How much sleep does an average teen need?

Answers

Answer: 9 to 9½ hours

Explanation:

? According to Johns Hopkins pediatrician Michael Crocetti , M.D., M.P.H. , teens need 9 to 9½ hours of sleep per night—that's an hour or so more than they needed at age 10.

Answer: 8–10 hours per 24 hours

Explanation:

The American Academy of Sleep Medicine has recommended that children aged 6–12 years should regularly sleep 9–12 hours per 24 hours and teenagers aged 13–18 years should sleep 8–10 hours per 24 hours.

HOW do you have a sprain in finger

Answers

Answer:

Sprained fingers are caused by physical impact to the finger. In most cases, sprains are caused by a blow to the end of a finger, which reverberates up to the joint and causes it to become hyperextended. This stretches or tears the ligaments. Sports injuries are extremely common causes of sprained fingers.

Explanation:

An injury that bends your finger too far backward (hyperextension) or the wrong way can lead to sprained fingers

Your welcome :)

If you see a disabled friend in your school, moving on a wheel chair, how would you
help him to climb up the stairs? Have you ever faced such situation before? If yes write
about that.

Answers

Answer:

what I would do is either use the lift if possible if there is no lift I would get another person to help me lift the front of the wheelchair and I would lift the back so I would be pulling the person on the wheelchair whilst the other person helping me would be pushing.

Which of the following would be the BEST activity to help you maintain a healthy skeletal system?
A. exercising often and eating a balanced diet
B. resting often and receiving proper immunizations
C. exercising often and eating only protein for your morning meal
D.
resting often and eliminating calcium from your diet
Please select the best answer from the choices provided.
O A
• B
O C
O D

Answers

Answer:

A is the correct answer.

Explanation:

Exercising often and eating a balanced diet helps you maintain a healthy skeletal system. D would be particularly unhelpful because calcium is important for the formation of strong bones.

A cross-connection is a link between?

Answers

A cross-connection is a link between the potable water supply and a source of contamination.

What is a Cross connection?

A cross-connection may be defined as a type of connection that significantly permits dirty water to go into a portable water supply. It is generally represented by the backflow of dirty water into potable water.

According to the context of this question, cross-connection governs the method of separating contaminated water from potable water. This sign represents the actual circumstance of water that is normally flowing in the water bodies.

Therefore, a cross-connection is a link between the potable water supply and a source of contamination.

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Which of the following describe the leader's role in concussion identification and management?
Select all that apply, then click Done.
A) Identifying Service Members who have been exposed to PCE
B) Referring Service Members for medical evaluation
C) Putting together a comprehensive treatment plan
D) Reporting potentially concussive events
E) Consulting with medical professionals
F) Determining when a Service Member is ready to return to duty

Answers

Answer:

A) identifying service members who have been exposed to PCE

B) referring service members for medical evaluation

D) reporting potentially concussive events

E) consulting with medical professionals

Explanation:

Leaders role must identify PCEs, or "Potentially Concussive Events," among service members. Remember the information and record incidents in the medical file. In addition to complete records, the service member's medical file must include the circumstances leading up to the concussion. A detailed report helps medical professionals diagnose and treat the patient. This continuous record helps understand the long-term consequences of concussions and ensures proper management throughout recovery.

Finally, military members' concussion diagnosis, treatment, and follow-up depend on accurate PCE and symptom data. This ensures team safety and prevents re-injuries. If medical personnel make treatment choices faster and more precisely, our wounded service member has a higher chance of recovering.

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According to the question, the answers are B, D, E, and F. The explanation is detailed below

B) Referring Service Members for medical evaluation: Leaders should be vigilant in recognizing signs of a potential concussion in Service Members under their supervision. If they suspect a trauma has occurred, they should promptly refer the affected individual for a thorough medical evaluation by qualified healthcare professionals. This ensures that the individual receives proper diagnosis and care.

D) Reporting potentially concussive events: Leaders play a crucial role in reporting any incidents that could result in a concussion, such as a blow to the head, exposure to a blast, or any other situation with a risk of causing a head injury. Accurate and timely reporting is essential for tracking and addressing potential concussions within the unit.

E) Consulting with medical professionals: Leaders should collaborate closely with medical professionals regarding concussion management. This involves seeking guidance, sharing information, and following medical recommendations for the affected Service Members. Effective communication between leaders and medical staff helps ensure proper treatment and a smooth recovery process.

F) Determining when a Service Member is ready to return to duty: While leaders don't make the final medical decisions, they can provide valuable input on a Service Member's readiness to return to duty based on their observations of the individual's performance, behavior, and adherence to medical instructions. This collaborative approach ensures that the Service Member's return to duty is well-informed and supported by medical expertise and the leader's assessment.

The combination of these responsibilities helps create a comprehensive approach to concussion identification and management, ensuring that Service Members receive appropriate care, their well-being is prioritized, and they can safely return to duty when medically cleared.

I hope it helps!  

How can two educators from different cultures work well together? (Select all that apply.)
a. Multiple select question.
b. Explore cultural differences.
c. Use a child as a translator.
d. Use constructive communication.
e. Ignore cultural differences.

Answers

Answer: Explore cultural differences, and Use constructive communication

Which of the following is true of genes?

Chromosomal diseases are caused by mutant genes.

Mutated genes lead to better health.

Hereditary characteristics come from both the mother and the father.

DNA consists of 16 pairs of chromosomes.

Answers

Answer: Hereditary characteristics come from both the mother and the father.

Which statement about grief is NOT true?
O Everyone grieves in the same way.
O Grieving is a process with several stages.
O One stage of grief is depression.
O Grieving helps people accept a loss.

Answers

the first answer is correct. not everyone grieves in the same way

3) “Turning down the volume” on repetitive information helps the sensory receptors cope with an overwhelming amount of sensory stimuli and allows time to pay attention to change, a phenomenon called _____________. a) perceptual constancy b) sublimation c) coding d) sensory adaptation

Answers

“Turning down the volume” on repetitive information helps the sensory receptors cope with an overwhelming amount of sensory stimuli and allows time to pay attention to change, a phenomenon called sensory adaptation.

Sensory receptors occur in specialised organs like the eyes, ears, nose, and mouth, yet as internal organs. every receptor sort conveys a definite sensory modality to integrate into one sensory activity frame eventually.

Sensory adaptation is a reduction in sensitivity to a stimulant once constant exposure to that. Whereas sensory adaptation reduces our awareness of a stimulant, it helps unencumber our attention and resources to attend to alternative stimuli in our surroundings. All 5 senses will expertise sensory adaptation.

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What is the CPT code for Hemiglossectomy?
What is the CPT code for a transnasal biopsy of the esophagus?
What is the CPT code for a percutaneous endoscopic colostomy?

Answers

The CPT code for Hemiglossectomy is 85124008 - Hemiglossectomy - SNOMED CT.

The CPT code for a transnasal biopsy of the esophagus is 0653T.

The CPT code for a percutaneous endoscopic colostomy is 43246.

What is a CPT Code and its uses?

The Current Procedural Terminology (CPT) codes provide doctors and other healthcare workers with a standard language for classifying medical services and procedures in order to improve reporting accuracy and efficiency.

CPT codes are used to describe tests, operations, assessments, and any other medical treatment carried out on a patient by a healthcare professional. As you can expect, this code collection is massive, containing codes for tens of thousands of medical operations.

CPT is a medical code set used to report medical, surgical, and diagnostic operations and services to institutions including physicians, health insurance companies, and accreditation agencies.

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what would you rather have: a loose constitution that can be updated by court decisions, or a rigid constitution that relies on popular amendments to keep up with the times? explain your reasons. Pls draw me what a velocity time graph would look like : moving at a positive constant speed to then at rest? Thank you!!! Is this the right answer? Jins mother estimates there is a half gallon of fruit punch remaining in the container. There is actually 72 ounces of fruit punch in the container. What is the percent error of Jins mothers estimate, rounded to the nearest tenth?PLS I NEED HELP ITS DUE IN 10 MINUTES!!!!!! Going to the pharmacy is "easy" for those of us who can see and hear. What do you think would be barriers and safety implications for those who are challenged in seeing and hearing?Think of when you go to the pharmacy and the steps you need to take when picking up a prescription. Keep in mind every single step and possible places where confusion could occur for the seeing and hearing impaired.Do you think going to the pharmacy will be easier now for you that you understand medical terms? restaurant akademay finds that there is sufficient demand for its products overseas. however, the restaurant doesn't have the resources to expand beyond the united states. which of the factors below prevent the company from targeting additional segments overseas? a substance or part of a substance (living or nonliving) that is recognized as foreign by the immune system, activates the immune system, and reacts with immune cells or their products is a/an: According to the graph provided, the weight for someone who is 1.4 meters tall is predicted to be close to kilograms you are a contestant in a quiz show, answering a series of questions. you answer correctly with probability p, or incorrectly with proabaility q; you get $1 for every correct answer, and you are eliminated when you first give two consecutive wrong answers. the questions are indepdent. find the expecred number of questions you attempt, and your expecred total prize moeny The mass of a test sample is 10 g, and it has a volume of 2.5 cm. What is its density?A. 10 g/cmB. 2.5 cm/gC. 4 g/cmD. 4 cm/gE. 0.25 g/cm simpire produces one product p1. their cost of materials is $6.20 per unit and the cost for labor is $1.20 per unit. they have an overhead cost of $ 240,000. if simpire budgets to sell 30,000 units, what is the total budgeted cost for every unit? Aidan walks 4 miles in 1 hour. At this rate, how many miles can he walk in 3.5hours? spanish A how do u ask what a word means in spanish PLEASE HELP!! PLEASE I WILL GIVE YOU BRAINLIST!! PLEASE ASAP :)LMNP is rotated 180 clockwise about the origin.What are the coordinates of M' ? in the simple quantity theory of money, the price level is assumed to be constant. group of answer choices true false what is the driest place on earth? group of answer choices death valley, california sahara desert, north africa atacama desert, chile great sandy desert, australia suppose a firm has had the historical sales figures shown as follows. what would be the forecast for next year's sales using the average approach? year20172018201920202021 sales$ 500,000$ 750,000$ 700,000$ 750,000$ 775,000 Mr. Young is replacing the fencing around his rabbit pens and garden. The table shows the dimensions of the different areas.Item Length (ft)Width (ft)Rabbit Pen 3.5 4.5Garden 12 10How many feet of fencing will he need to replace two rabbit pens and his garden? The perimeter of a rectangle is 2+2w2+2w, where is the length and w is the width.__ ft A cube-shaped gift box has a volume of 1000 cubic inches. Solve s = 1000 to find the lengths of one side of the box.s=__in. Write a system of equations to describe the situation below, solve using elimination, and fill in the blanks.A boy scout troop is selling Christmas trees at a local tree lot. In the morning, they sold 6 Douglas Fir trees and 16 Noble Fir trees, earning a total of $986. In the afternoon, they sold 6 Douglas Fir trees and 24 Noble Fir trees, earning a total of $1,386. How much does each type of tree cost?A Douglas Fir costs $_____ and a Noble Fir costs $_______