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

Should I be concerned if I'm having bowel movements sometimes every day and sometimes every 5 days, but no hard stools? Please explain

Answers

It would probably be best to get medical help

Which of the following is NOT a benefit of cardiorespiratory fitness?
A.
More blood is pumped through the body.
B.
The risk of cardiovascular disease is decreased.
C.
Longer durations of large muscle exercises are possible.
D.
The efficiency of the respiratory system increases.

Answers

It’s C- Longer durations of large muscle exercises.

Answer:

A.

Explanation:

that was the only one that is just a fact, not a benefit

Batters should be prepared ______.
- as quickly as possible
- in small patches so that foods spend less time in the TDZ
- by master chefs who have been trained in preparation of egg-based food items
- away from direct sunlight

Answers

Answer: by master chefs who have been trained in preparation of egg-based food items, in small patches so that foods spend less time in the TDZ

Explanation:

Batters should be prepared by master chefs that are already knowing how to make them because of the items that are going in it such as eggs and various flavoring materials that are used.

The preparation is not so quick because you must leave it a couple of hours.

The sunglight has nothing to do with preparation but after that, we should not keep in where to direct sunlight is.

Also, it should be made in small patches because a high and dangerous temperature zone is dangerous for it.

Your grandfather is sch

Answers

Answer:

umm, okay?

Explanation:

Answer:

im confused

Explanation:

Susan performs a breast exam each month. Which changes might warrant a trip to a doctor for further testing? losing fullness in breasts after weight loss having occasional changes in breast size feeling irregularities on the surface of the breast

Answers

Answer:

the correct answer is feeling irregularities on the surface of the breast.

Hope This Helps! Sorry for answering so late.

Feeling irregularities on the surface of breast can be a sign to take a trip to a doctor for further testing. The correct option is C.

What are breast lumps?

Breast lumps can be triggered by a mixture of factors. They are frequently caused by something non-cancerous, such as a fibroadenoma or a fluid buildup (breast cyst).

Feeling irregularities on the surface of breast can be a sign to take a trip to a doctor for further testing as this can be a sign of any disorder.

Thus, the correct option is C.

For more details regarding breast lumps, visit:

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Hello hola why yall so much drama??

Answers

I have no idea lol but people jus like arguing
wHaT cOuLd yOu pOsSiBlY mEaN?

also could u plz give me brainlyist?
I only need 3 more

When passing the soccer ball, what part of the foot do you use? *
O Top/Laces
O Heel
O Toes
O Inner side

Answers

Answer:

Inner Side

Explanation:

Why do you need to gradually increase your physical activity to stay within your fitness target zone?

Answers

Answer:

A rule that states that the amount and intensity of physical activity needs to be increased gradually. ... Physical activities that the heart can supply adequate oxygen to the muscles and allow performance for a long period of time.

Explanation:

Since your body gets used to the current physical activity so you must increase or change your physical activity in order to stay within your fitness target zone.

How should you lift and move to reduce the risk of strain and injury?

Answers

Answer:

Try watching a video of stretching the injury.

Explanation:

What functions of the brain are affected by alcohol use? *


A. Hearing and blood pressure
B. Memory and decision-making
C. Stomach pain and ulcers
D. Bone density & deterioration

Answers

Answer: B. Memory and decision making.

Explanation: Alcohol has a profound effect on the complex structures of the brain and the memory is similar to the brain

Sheldon has a traditional health insurance plan. He has a $200 deductible. The level of co-insurance for his plan is 90/10, where 10 represents Sheldon’s portion. He does not have a co-payment. If Sheldon incurs a $1,500 hospital bill, how much money will the insurance company pay for the bill?

A.
$1,170
B.
$1,350
C.
$1,150
D.
$970

Answers

The answer should be:B

Answer: b

Explanation:

If a patient experiencing problems with balance and coordination, how can you tell if the problem lies within the cerebellum or the ears, which are also responsible for balance and coordination? 

Answers

Answer:

The cerebellum

:)))))))

Answer:

The cerebellum is responsible for balance and coordination.

Explanation:

yes ik someone else put the answer but ik what the answer is too from science

Which of the following may trigger elder abuse bya caregiver?

Answers

Answer:

Common personal problems among caregivers that can lead to elder abuse include the following:

~Being under excessive stress due to chronic fatigue.

~Having an overwhelming amount of daily responsibilities.

~Suffering from illicit drug abuse, including the excessive use of alcohol.

Anticipating disaster and developing a plan before an emergency is an example of being
stable.
O proactive.
collaborative
courteous.

Answers

Answer:

proactive is the answer

Answer:

A

Explanation:

Which organ system is responsible for filtering our blood and removing the liquid waste?
Group of answer choices

respiratory system

nervous system

excretory system

skeletal system

Answers

Excretory system which includes the kidney

In what circumstances would you use each resource in your community? list 3 reasons

a)

b)

c)

Answers

a) For our reference sheet, as an example, we could call poison control if one of us had consumed a poisonous food.

b) A first aid kit has an ice pack and icy hot which could help if someone has a first or second-degree burn.

c) The internet access could help us if we needed to find the number to a local authority in case something in the streets is happening and it isn’t of the most serious problems.

Can someone please help me?

Answers

Answer:

d

Explanation:

the last one. ........

The answer would be d

You should start an exercise regimen before seeing a health professional for advice.

Answers

no. always consult a doctor before starting a health plan

Answer:

False

Explanation:

Edge

who loves by broken dog lol

Answers

Answer:

meeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee

Explanation:

I do! They’re so cute!

>w<

You have decided that you are ready to start a fitness program. you have not exercised on a regular basis in about a year. what principles of exercise should you consider when starting a new exercise regime and what should you do before and after every workout to minimize injuries. << read less

Answers

Before working out you should stretch or warm up. You should not drink water before starting because it will jiggle in your stomach and can make you throw up. start with something easy. Excercises that will make your heart pump. You should do something that you like. After your workout, drink lots of water.

Read the document: www.fda.gov
Assignment Guidelines:
[Write a 250-word summary of the main points of the article. Then write a 250-word analysis, answering the questions:
Why is this regulation so important?
Why is it important for food-service managers to know the law?
What is the risk of not knowing and complying with the law?

Answers

Explanation:

the link ain't opening and that does not worth 5 marks

Answer:

www.fda.gov

Explanation:

heres the link

For every 1000hits a You.tube channel gets it makes £2 from ad revenue.
How many hits are required to make £25?

(proportion)

Answers

Answer:

£12500.00

Explanation:

1000/2=x/25

x=25*1000/2

x=25000/2

x=12500

Hope this helps plz hit the crown :D

Answer: At least 13,000 hits = 26

Explanation:1000 x 13 = 13000

Question #5
Dropdown
Choose the option that best matches the description given.
A facility's
v should be well-lit and regularly monitored for trash.
Cooler
offices
Questio
Dropdown exterior
trash bins

Answers

A facility’s offices should be well lit and regularly monitored for trash

Answer:

The answer would be exterior

Explain how the diverse and cultural influences have impacted health care delivery.

Answers

Answer:

Since the 1970s, historical studies of food in particular cultures have emerged as a new field, “culinary history.” Culinary history studies the origins and development of the foodstuffs, equipment, and techniques of cookery, the presentation and eating of meals, and the meanings of these activities to the societies that produce them. It looks at practices on both sides of the kitchen door, at the significance of the food to the cook and to those who consume it, and at how cooking is done and what the final product means. Consequently, culinary history is widely interdisciplinary. Studies make connections between the sciences – medical, biological, and social – and the humanities and draw heavily on anthropology, economics, psychology, folklore, literature, and the fine arts, as well as history. These multidisciplinary perspectives are integrated along geographic and temporal dimensions, and as a consequence, culinary history encompasses the whole process of procuring food from land or laboratory, moving it through processors and market-places, and finally placing it on the stove and onto the table. It emphasizes the role that food-related activities play in defining community, class, and social status – as epitomized in such fundamental human acts as the choice and consumption of one’s daily bread.

Culinary history can also be defined by what it is not. It is not, for example, simply a narrative account of what was eaten by a particular people at a particular time. Nor is it a matter of rendering entertaining stories about food, or telling anecdotes of people cooking and eating, or surveying cookbooks.

Explanation:

hope this helped! :)

mutual monogamy removes all the chances of a person contracting and std/sti
a. TRUE
b.FALSE

Answers

False it is not true even if you have mutual monogamy you can still get it
false.
i agree with the person above

A system in which patients pay doctors for health care is known as a:
A. fee-for-service system.
B. universal system,
C. health maintenance organization,
D. capitalist system.

Answers

Answer:

fee for system service

Explanation:

The correct answer would be, Fee-for-service. A System in which patients pay doctors for health care is known as a Fee-for-service

Complete the following sentence.
Being a grandparent provides an opportunity to ___
support,
and nurture without having all the daily responsibility of raising a chil

Answers

Answer: Comfort

Explanation:

Being a grandparent provides an opportunity to comfort

support,

and nurture without having all the daily responsibility of raising a child.

All those daily responsibilities should have parents of a child, and grandparents are known as the best support after parents that one child could have.

Grandparents are usually spending two or tree days with their grandchildren in one week which is enough for them because they can get tired easily and everything depends on their age.

Answer:

love

Explanation:

edge2021

The amount of force that muscles can aply to move a heavy object is known as: A. Explosive strength B. Dynamic strength C. power D. static strength ​

Answers

Answer
D I think static strength

D static strength

Explanation:

explain how the modern fluid mosaic model of membrane structure differs from davson danielli model​

Answers

Answer:

The fluid mosaic model of membrane structure is a cell membrane that behaves like a two- dimensional liquid of mixed composition. The cell membrane is described to be fluid because of its hydrophobic components that are integrated into the membrane structure such as lipids and membrane proteins that move sideways throughout the membrane.

Hopefully, this answer helps! And have a great rest of your day! :D

Transmembrane proteins were added to the Fluid Mosaic Model, which improved upon the Davson-Danielli Model and deleted the earlier proposed flanking protein layers that were not adequately supported by experimental evidence.

What is modern fluid mosaic model of membrane structure?

The cell membrane in the fluid mosaic model of membrane structure acts like a two-dimensional liquid with a mixed composition.

Because of the hydrophobic elements that are included into the membrane structure, such as lipids and membrane proteins that flow sideways through the membrane, the cell membrane is said to be fluid.

According to the fluid mosaic theory, the cell membrane is made up of several continually moving components, including phospholipids, cholesterol, and proteins.

This movement aids the cell membrane in preserving its function as a partition separating the interior and exterior cell surroundings.

Therefore, the modern fluid mosaic model of membrane structure differs from danielli model​.

Learn more about fluid mosaic model of membrane here:

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what are some of the observation properties of substances​

Answers

Answer: Color, shape, size, texture, volume, and mass

Explanation:

Color, shape, texture, volume, mass, and size are the most important things when it comes to the observation of anything and also substances.

When we are looking at some substance and observing it at first we can see mass, size, and color. After that, we can look better to see the texture of it which is also important.

These things are considering everything that person can see with their eyes.

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