A drug manufacturer wants to provide a generic version of a trade-name drug that eliminates all symptoms of an illness. Its laboratory studies show that the pill contains no dangerous chemicals, reduces symptoms of the illness, and has been produced consistently. Also, no deaths have occurred in the trial period. Why would this drug fail FDA approval as a therapeutic equivalent drug?

Answers

Answer 1

Answer:

Explanation:

There are some reasons why a generic version of a trade-name drug could fail FDA approval as a therapeutic equivalent drug but what is described in the question suggests that the active ingredient of this generic version is different from that of the "original" trade-name drug. The reason is because, all the properties of the drug mentioned should have been compared to that of the original trade-name drug to prove bioequivalence - as the therapeutic effects of this drug should be in comparison to the original trade-name drug and not just be of it's own as suggested (for example, the drug should reduce symptoms of the illness with the same strength the trade-name does and not just as written that it reduces the symptoms of the illness) in the tone used in the question.


Related Questions

40 points
When performing Hands-Only CPR, how many times should you push in
the center of the chest during a one minute period?

1-At least 50
2-At least 150
3-At least 100

Answers

Answer:

100-120 , so at least 100

Explanation:

Answer:at least 100

Explanation:just took the exam

*
Food is an) commodity.

Answers

Answer to your question: true

Food is an commodity, because humans use it in everyday life.

A commodity is something used constantly

check whether 12^n can end with the digit zero for any natural number n.​

Answers

Answer:

No, 12^ 0 is 1, 12^1 is 12 so it  cant end.

Hope this helps :D

im a type one diabeic anyone else :D

Answers

Answer:

not me my friend is tho

Explanation:

I’m not sure! I hope everything is okay

explain how emotions represent your mental and emotional health?

Answers

because by having emotions u express however ur feeling at the time

Answer:

for example if your happy your emotional healthy will be good and if your sad you won't have good emotional health.

You will see the greatest improvement in cardiorespiratory endurance by applying which of the following FITT Principle variables?
1 Frequency (5-7 sessions per week)
2 Intensity (51%-65% of maximum heart rate)
3 Time (50 minutes or less)
4 Type (weight lifting and stretching)

Answers

I believe it’s 1 aka frequency

Answer:

I think it is 2

Explanation:

A medical intern enters a room and sees a patient, a surgeon, and nurses. In order for the surgical team to be complete
who else needs to be in the room?
team leader
anesthesiologist
scribe
family doctor

Answers

Answer:

family doctor

Explanation:

just did test

Answer:

Anesthesiologist

Explanation:

In order for a surgery to be performed there has to be a anesthiologist on the surgical team.

Question 8: Write the following sentences in the correct sequence in order to complete a
paragraph that explains how the inner ear & brain interpret sound.

: Action potentials are sent from the cochlea to the cochlear nerve.
: From the cochlear nerve the sound messages are sent through the auditory pathway
into the cerebral cortex of the brain where the sound will be interpreted.
: Within the basilar membrane contain more than 20,000 fibers that resonate at different
frequency allowing different pitches to be immediately transmitted to the nervous system.
: The hearing function of the labyrinth in housed in the snail shaped portion called the
cochlea
: The cochlea consist of 3 main chambers.

Answers

Answer:

The correct sequence of the following sentences inorder to form a complete paragraph explaining how the inner ear and brain interpret sound include:

: The hearing function of the labyrinth in housed in the snail shaped portion called the  cochlea

: The cochlea consist of 3 main chambers.

: Action potentials are sent from the cochlea to the cochlear nerve.

: From the cochlear nerve the sound messages are sent through the auditory pathway  into the cerebral cortex of the brain where the sound will be interpreted.

: Within the basilar membrane contain more than 20,000 fibers that resonate at different  frequency allowing different pitches to be immediately transmitted to the nervous system.

Explanation:

First One with explanation, GetsBrainlestSome symptoms of the flu are similar to the common cold but blank
Amore severe
B not as bad

Answers

Answer:

Are more severe :) Hope this helps

Which of the following could lead to type 2 diabetes?

Sexual activity
Smoking
Obesity
Taking drugs

Answers

Answer:

Smoking but sometimes all of the above

Explanation:

all of the above i’m pretty sure

Can some one answer this??? How can a heart monitor enhance fitness levels?

it can determine how much cholesterol is in your blood while working out

it can indicate when you are working above, below, or in your target zone

it can predict the type of activities that will benefit your workout

it can identify whether you have worked out for the appropriate amount of time

Answers

Answer:

They can view the amount of beats per minute you have based on different activities your doing through the day. The higher fitness level your heart is in, the more or less beats it’ll have when performing different physical activities based on your hearts fitness level.

Explanation:

Answer:

B. it can indicate when you are working above, below, or in your target zone

Many of the lifestyle choices a person makes and behaviors he or she develops begin in _______________.

A
adulthood

B
childhood or adolescence

Answers

Answer:

B. Childhood or Adolescence

Explanation:

This is when the most development occurs

repeated and exclusive use for alcohol will cause damage to them. stomach, liver ,brain , heart , all of above​

Answers

Answer:

Liver,brain and heart

Explanation:

Please give me brainliest;)


HELP ME PLEASE IM BEGGING YOU PLEASE PLEASE PLEASE

Answers

Answer:

Emotional

Explanation:

Emotional/Mental Dimension

Coping effectively, having a sense of positive self-regard, and creating satisfying relationships.

Keep a positive attitude.

Be sensitive to your feelings and the feelings of others.

Learn to cope with stress.

Be realistic about your expectations and time.

Fungus that thrives on moisture & warmth and produces carbon dioxide for leavening.

Answers

Answer:

Yes

Explanation:

Baker's yeast

what is your biggest fear u have not told anyone in your like

Answers

Answer:

I'm scared of the dark, and that I'm scared to watch scary movies with or without people, my brother, and cousin.

Explanation:

I'm scared of the dark because of my nightmares, and I'm scared to watch scary movies alone or with people around because I still think about it, and it scares the daylights out of me.  I'm afraid of my brother and cousin.  So yeah, that's pretty much it.

Answer:

My biggest fear is people hating my writing.

Explanation:

I love to write. I wrote since I was 7 years old. I want to be an author. I just don't want someone telling me "No, I'm sorry. We're rejecting your writing." In my brain, I feel like they are saying that they hate my writing.

1. Athletics is classified into
A. Jump and throw B. Sprint and long
C Track and field D. Stunt and tumbling.
2. Warming up is necessary to
A. Loosen muscle B. Reduce muscle
C. Sweat D. Reduce weight
3. Which of the following is not a sprint?
A. 1500m B. 100m C. 200m D. 75m
4. In relay race anchor leg is the leg.
A. First B. Second C. Third D. Fifth
5. Under which event will you classify hurdle
A. Games only
B. Sport and games
C. Field event
D. Track event
6. During relay race, if athlete should run to the finishing line w
baton, the official will
A. Displace him B. Disqualify him
C. Beat him
D. Allow him to look for his baton
7. A record is said to have been broken in athletic
Competition when
A. The former record is equal
B. A musical record drops and breaks
C. An athlete increase on the existing record
D. An athlete breaks his or her leg
8. Rhythmical activities are the following except
A. Marching B. Dramatics C. Archery
D
9. Recreational activities is for
A. Sick people
B. All ages
C. Wealthy people
10. The 3Rs in waste management means
A. Reduce, Repack and Reuse B. Land pollution
C. Reduce, Reuse and Recycle D. None of the above
11. Human trafficking denotes
A. Movement B. Exploitation C. Transferring
12. Which of these is not among the solution for human tr
A. Economic stability B. Government actions
C. Awareness Programs D. Forced labour​

Answers

Answer:

C. A.A.D.C.B.C.C.B.C.C.C.D

Explanation:

I majored in Health.

In a medical journal patients wrote an article about dietbetes, should you rely on the information?Why?

Answers

Answer: Could be trusted as the work of these patients may have been monitored and verified.

Explanation:

Medical journals are a type of journal where the content that is published is from the health area and by professionals, especially researchers. The content that is normally displayed in this magazine is content that has been supervised and made by an expert. In the case of patients with diabetes, their work may have been reviewed.

The endocrine system is made up of different

Answers

Answer:

glands that make hormones

Explanation:

The endocrine system is made up of glands that make hormones. Hormones are the body's chemical messengers. They carry information and instructions from one set of cells to another. The endocrine (pronounced: EN-duh-krin) system influences almost every cell, organ, and function of our bodies.

Can I have brainliest? : )

What triggers unconsciousness?

Answers

can be caused by nearly any major illness or injury. It can also be caused by substance (drug) and alcohol use. Choking on an object can result in unconsciousness as well. Brief unconsciousness (or fainting) is often a result from dehydration, low blood sugar, or temporary low blood pressure.

Explanation:


Why are physical fitness attitudes important?
A. They are able to change our moods.
B. They reflect our internal ethics.
C. They show others how we feel.
D. They influence our activity levels.

Please select the best answer from the choices provided.
Ο Α
OB
ОС
OD

Answers

Answer:

A.

Explanation:

hope this help, goodluck!

Answer:

D

Explanation:

the answer is D because the attitude you have about something can effect the effort you give to that activity

how do i stop Period cramp?​

Answers

Answer:

Drink water

Explanation:

Something warm and has some weight always helps me when I put it in the area that's cramping... I hope this helps :)

Answer:

drink some warm tea

Explanation:

it doesn't have to be tea but drinking something warm or taking a bath always helps me.

does it take 18 months for twins to be born

Answers

No same time as 1 baby

Answer:

no

Explanation:

babies no matter how many will take abt 9 months cus they develop at the same rate as regular babies.

What is the purpose of assessing flexibility as part of a fitness program

Answers

Answer:

Measuring the flexibility of your joints is important because it determines if you have postural imbalances, 10 foot instability, or limitation for your motion range.

A ______ is an exchange of consecutive shots in badminton.


A) Rally

B) Love

C) Alley

D) Match

Answers

Match is the answer I believe

Answer:

C) Alley

Explanation:

label the heart
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.

Answers

Answer:

just scearh it up then that would be the answer

Explanation:

My body is in pain but there's no reason why it should be :')
My head hurts, my legs hurt, my back hurts, any advice???

Answers

Try taking advile or lay down and rest a little put vapor

Answer:

maybe get some rest for 7-12 hours if your body is swore maybe take a ice bath .! but if your still on pain after 2-3 days you should go to the doctor.!

Having a theme helps you pick out furniture, decorations, and paint that go well together. True False

Answers

True
I took the test

How do heredity and environment work together in intellectual development

Answers

Answer:

Our genetic predispositions and our surrounding environments interact. Environments can trigger gene activity, and genetically influenced traits can evoke responses from others.

hope this helps:)

Someone plz help its 11:30pm i cant think.
what is salmonella? how can you avoid salmonella?

Answers

Answer:

An infection with salmonella bacteria, commonly caused by contaminated food or water.

Explanation:

Avoid eating raw or barely cooked eggs.

Don't eat raw or undercooked beef, pork, or poultry.

Refrigerate food properly.

Wash hands well with soap and warm water before and after handling food.

Clean kitchen surfaces before preparing food on them.

Answer:

Salmonella is basically eating raw meat. The stuff inside of it can poison a human. You can avoid it by cooking meat well and not eating raw foods.

Explanation:

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