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When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of progress report to FDA.
Located under the Department of Health and Human Services, the Food and Drug Administration (FDA or USFDA) is a federal organization. The FDA is in charge of ensuring the safety of food, tobacco, caffeine, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products in order to protect and advance public health.
The Federal Food, Drug, and Cosmetic Act (FD&C) is the FDA's major area of enforcement, although the organization also upholds related regulations and other laws, most notably Section 361 of the Public Health Service Act.
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Related Questions
Why is diffusion important in the ocean
Answers
What is the Calvin cycle?
A series of light dependent reactions
A series of light independent reactions.
Light dependent and light independent reactions
Another name for the production of chloroplasts.
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The Calvin cycle is a series of light-independent reactions that occur in the chloroplasts of plants.
These reactions are responsible for converting carbon dioxide into glucose, which is the main source of energy for the plant. The Calvin cycle is also known as the Calvin-Benson cycle or the C3 cycle. The cycle consists of three main stages: carbon fixation, reduction, and regeneration. During carbon fixation, an enzyme called Rubisco combines carbon dioxide with a five-carbon molecule called RuBP. This results in the formation of two three-carbon molecules known as PGA. In the reduction stage, ATP and NADPH, which are produced during the light-dependent reactions, are used to convert PGA into G3P. Some of the G3P molecules are used to regenerate RuBP, while others are used to produce glucose and other organic compounds.For more questions on Calvin's cycle
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7. Which statement best describes how homologous structures evolve?
A) A basic structure inherited from a common ancestor may evolve different variations in differnet species.
B) The same structure evolves in two different species when the same mutation occurs independently in both species.
C) Similar structures evolve independently in distantly related species that experience similar problems in their habitats.
D) Members of a species come to resemble each other strongly as extreme structures are eliminated from the species.
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option (a) A basic structure inherited from a common ancestor may evolve different variations in different species.
Biology defines homology as resemblance resulting from a shared ancestor between two structures or genes in various taxa. The forelimbs of vertebrates are a typical example of homologous structures.
These forelimbs are descended from the same ancestral tetrapod structure as the wings of bats and birds, the arms of primates, the front flippers of whales, and the forelegs of four-legged vertebrates like dogs and crocodiles. According to evolutionary biology, similar structures that have been modified to serve various functions descended from a common ancestor.
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help^
answer that......
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Answer:
yes yes yes no yes
Explanation:
What is a population?
A. a group of organisms of different species interacting with each other and the environment
B. a single separate organisms separate from others of the same kind interacting with it's environmment
C.all the organisms of the same species who live in a specific environment and are capable of interbreeding.
D.a group of organisms and the non-living components interacting as a system
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Answer:
What is population?
A group of organisms of different species interacting with each other and the environment is called populatin.
You are going on a space trip. You fly in a shuttle from Earth to Mars. You leave Mars and shuttle over to Saturn. On
which planet did you have the MOST mass?
(A) Jupiter
(B) Earth
Mars
(D) None. My mass did not change.
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Answer:
Jupiter
Explanation:
I would say that because Jupiter already has a lot of mass on it and I would suspect that you would too. But I am not sure if it is 100% right, so correct me if I am wrong! Have a nice day! :)
NAMING BRAINLIEST!! Choose all the answers that apply.
Energy in an ecosystem:
is part of an open system
is recycled and reused
flows only one way
is transferred through the food chain
is eventually lost as heat
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Answer:
Energy in an ecosystem: is part of an open system, is recycled and reused, is transferred through the food chain and is lost as heat.
pls help me
I really need help with this and why do I have to write 20 words to have a great awnser.
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Answer:
A does dissolve in a greater degree as the temperature increases. B does not dissolve up to 80 degrees.
In the fluid mosaic model, where would you most likely find the transport proteins?
Attached to the outer portion of the phospholipid bilayer
Embedded within the hydrophobic and hydrophilic regions of the bilayer
Flipping, alternating between the hydrophobic and hydrophilic regions of the bilayer
Roaming within the phospholipid bilayer
thanks so much
Answers
Answer:
B: Embedded within the hydrophobic and hydrophillic regions of the bi layer
Explanation:
They are integral protiens and have to be inside
i took a test
This movement aids the cell membrane in preserving its function as a partition separating the interior and exterior cell surroundings. Thus option B is correct.
What is the role of transport protein in fluid mosaic model?Integral proteins protrude from each end of the phospholipid bilayer and are tucked inside. Larger molecules like glucose can be transported through cell membranes with the aid of integral proteins.
They have sections that match the polarity of the phospholipid bilayer, known as "polar" and "nonpolar" regions.
This movement aids the cell membrane in preserving its function as a partition separating the inside from the outside environments of the cell.
Therefore, in the fluid mosaic model, the transport protein is connected to the phospholipid bilayer's outer layer.
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25. (10.04 MC)
Which of the following items should be included in a family preparedness plan?
1. A survival kit
II. An evacuation plan
III. A list of valuable furniture
IV. A list of emergency contacts
(1 point)
I and Il only
II and III only
I, II, and III
I, II, and IV
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Answer:
I,II and IV
Explanation:
A Survival kit with everything needed for emergencies. contacts of family and doctors and a plan to get to safety.
This is an image of an electrocardiogram Which statement describes the condition of the heart at the point indicated in the electrocardiogram? The muscles of the atria depolarize. The muscles of the ventricles depolarize. The muscles of the atria repolarize. The muscles of the ventricles repolarize.
Answers
Answer:
C
Explanation:
Answer: the muscles of the ventricles repolarize.
In the current public health model, trying to reduce the impact of disease or injury that has already occurred is an example of ____________________________ prevention.
a. Primary
b. None of the above
c. Secondary
d. Tertiary
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Answer:
d. Tertiary prevention.
Tertiary prevention aims to soften the impact of an ongoing illness or injury that has lasting effects.
Explanation:
this is because it has already occurred and no one was able to attend to it. so you trying to work on it makes it unique.
Two species a cactus and a Venus fly-trap, have a water intake system that’s similar in function but not in structure. What type of structure is this
Answers
Answer:Are there answer options?
Explanation:
Select all the correct answers.
Which of these facts were established by other scientists before Charles Darwin published his famous theory of evolution in 1859?
A. Many species have become extinct over time.
B.Variation in characteristics results in the birth of new species.
C.There are many similarities in the anatomy of humans and other species.
D.There are processes in nature that produce organisms that are not able to adapt to the environment.
E.The relationship between evolution and the unity and diversity of life on earth was studied on a large scale.
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The facts that were established by other scientists before Charles Darwin published his famous theory of evolution in 1859 were A. Many species have become extinct over time and C. There are many similarities in the anatomy of humans and other species.
What is the theory of evolution proposed by Darwin?The theory of evolution proposed by Darwin is a scientific model to explain how organisms adapt (evolve) regarding environmental conditions
Therefore, with this data, we can see that the theory of evolution proposed by Darwin was based on different previous assumptions.
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Where does precipitation occur in the water cycle? Illustration of a water cycle. Has white clouds, Dark color clouds with rain, water bodies, and water evaporating. Also, has a Sun on the left corner. A. A B. B C. C D. D
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Precipitation occurs in the water cycle in stage C. During this stage, the water vapor that has been evaporated from water bodies, plants, and other surfaces condenses into clouds due to cooling.
As more water vapor condenses, the clouds become heavier and cannot hold all the moisture, leading to precipitation in the form of rain, snow, sleet, or hail.
The water cycle begins with the sun's energy evaporating water from oceans, rivers, lakes, and other water bodies. This water vapor then rises into the atmosphere, where it cools and condenses into clouds during stage B. Once the clouds become too heavy, precipitation occurs, and the water returns to the Earth's surface, either directly into oceans, lakes, and rivers or as groundwater. This completes the water cycle, and the process starts over again.
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Can you list more than four traits that are inherited in plants?
Answers
Answer:
flower color, flower position, seed color, seed shape, seed pod shape, pod color, leaf pattern, and stem length.
Explanation:
Some common inherited characteristics
What are the names of the dogs that come from Gray Wolfs and share a common ancestor.
Answers
The dogs that come from Gray Wolves and share a common ancestor are: Alaskan Malamute, Siberian Husky , Eurasier , Finnish Lapphund ,Tamaskan Dog , Utonagan , Saarloos Wolfdog , Czechoslovakian Wolfdog , Kugsha etc.
What is ancestor?An ancestor can be defined as the progenitor of a group of organisms from which a species or population is descended. In biology, an ancestor is a species or organism from which a group of organisms or a species has evolved. The ancestor is the origin of the evolution of the group, and its characteristics are passed down to the descendants. An ancestor plays a critical role in the evolutionary process, as its characteristics are passed down to the future generations, allowing for adaptation and survival.
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There are ____ molecules of air at high elevations, so air pressure is less. a. fewer c. more b. the same number of d. no Please select the best answer from the choices provided A B C D
Answers
Answer:
A. Fewer
Explanation:
This is the only answer that makes sense
Which of the following is NOT a type of connective tissue?
A. cartilage
B. transitional
C. blood
D. bone tissue
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Transitional tissue is a type of epithelial tissue. Therefore, it is not a type of connective tissue!
Bone and bone tissue are types of connective tissue that make up your skeletal system. Cartilage is also a type of connective tissue. And amazingly, blood is also a type of connective tissue, since it transports nutrients within.
When the spine curves inward at the low back this is referred to as
Answers
Answer: Lordosis
Explanation:
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Iron oxide reacts with aluminum to give aluminum oxide and iron. What kind of chemical reaction is this?
Answers
Answer: Replacement Reaction
Which element makes some rocks glow, helps oysters form pearls, and creates amazing cave formations?
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The element which makes some rocks glow, helps oysters form pearls, and creates amazing cave formations is referred to as aragonite.
What is an Aragonite?This refers to an element which is similar to calcite as it also consists of calcium carbonate but however differs from it because it undergoes orthorhombic crystallization. It is formed from different biological and physical processes such as precipitation which goes on in the aquatic ecosystem.
This elements performs various functions in different substance such as making some rocks glow, helps oysters form pearls, and creates amazing cave formations.
This is therefore why aragonite was chosen as the most appropriate choice.
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What are tissues made of?
A. Groups of organs
B. Groups of reflexes
C. Groups of cells
D. Groups of systems
Answers
Answer:
C
Explanation:
A tissue is made up of lots of the same type of cells
Answer:
C. Groups of cells
Explanation:
They are made up of cells. When they are formed together, they carry out specific functions.
for body sharp the domain trait is
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Those with one copy of the dominant allele, which might come from only one parent, will have a dominant phenotype.
What is the difference between a dominant and recessive phenotype?In people who only have one copy of allele, which could also come from one parent, a dominant allele results in a dominant phenotype. A recessive allele requires two copies—one from each parent—in order to result in a recessive phenotype in the individual.
Is the phenotype of AA dominant?A capital letter is used to identify a dominant allele (A versus a). The combinations are AA, Aa, and aa because each parent contributes one allele. The dominant trait will be phenotypically displayed in offspring with either an AA or an Aa genotype, while the recessive trait will be expressed in aa individuals.
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Examine the diagram of the carbon cycle.
How do plants and animals interact in the cycling of oxygen?
Plants produce oxygen needed by animals for respiration.
Both plants and animals consume oxygen during photosynthesis.
Plants produce oxygen needed by animals for photosynthesis.
Animals produce oxygen needed by plants for respiration.
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Answer:fter photosynthesis, plants release oxygen into the atmosphere. This is one of the most significant ways that plants contribute to the carbon cycle's oxygen cycling.
In the process of photosynthesis, plants create oxygen and glucose, a form of sugar, from carbon dioxide, water, and sunshine. Animals and other species use the waste product of photosynthesis, oxygen, which is discharged into the atmosphere, for breathing. Overall, photosynthesis and plant respiration are just two examples of the numerous creatures and natural processes that contribute to the intricate process of oxygen cycling in the carbon cycle.
Therefore, the correct option is B.
Explanation:
Your proof is that i had a unit like this and i got a 100
11)
A) In which part of the alimentary canal is digested food absorbed? 1 mark
B) Describe THREE ways in which this part is adapted for absorption. 3 marks
Answers
Answer:
1. the small intestine and large intestine
2. sry don't know
In humans, the presence of freckles is a dominant inheritance, and their absence is a recurrent trait. The shape of the eyebrows is also a hereditary characteristic, the separate eyebrows being a dominant characteristic, and the joined eyebrows being a recurring character. In a couple, the woman has freckles and separate eyebrows, and she is heterozygous for both characters. The man does not have freckles, but he has eyebrows closed. How likely is their child to have freckles and separate eyebrows? Use a tree diagram or a Punnett square to justify your answer.
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When crossing a woman -who is heter0zyg0us for freckles and shape of eyebrows- with a man -who is h0m0zyg0us recessive for both traits-, the likelihood of their child to have freckles and separate eyebrows is 1/4 = 25%.
-------------------------------------------
Available data:
Two diallelic genes ⇒ One of them codes for freckles and the other one for the shape of the eyebrows.Freckles ⇒ Dominant allele F ⇒ Codes for freckles.⇒ Recessive allele f ⇒ No freckles.
Eyebrows shape ⇒ Dominant allele E⇒Codes for separate eyebrows.⇒ Recessive allele e ⇒ Codes for joined eyebrows.
Woman ⇒ Heter0zyg0us for both genes. She has freckles and separate eyebrows.Man ⇒ H0m0zyg0us recessive for both traits. He does not have freckles, but he has eyebrows closed.Cross: The woman with the man
Parentals) FfEe x ffee
Gametes) FE, Fe, fE, fe ⇒ woman
fe, fe, fe, fe ⇒ man
Punnett Square) FE Fe fE fe
fe FfEe Ffee ffEe ffee
fe FfEe Ffee ffEe ffee
fe FfEe Ffee ffEe ffee
fe FfEe Ffee ffEe ffee
F1) Genotype:
4/16 = 1/4 = 25% of the progeny will be heter0zyg0us for both traits, FfEe4/16 = 1/4 = 25% of the progeny will be heter0zyg0us for freckles, but h0m0zyg0us recessive for eyebrow trait, Ffee4/16 = 1/4 = 25% of the progeny will be heter0zyg0us for eyebrow trait, but h0m0zyg0us recessive for freckles trait, ffEe 4/16 = 1/4 = 25% of the progeny will be h0m0zyg0us recessive for both traits, ffee.
Phenotype:
4/16 = 1/4 = 25% of the progeny will have freckles AND separate eyebrows, FfEe4/16 = 1/4 = 25% of the progeny will have freckles AND closed eyebrows, Ffee4/16 = 1/4 = 25% of the progeny will not have freckles AND will have separate eyebrows, ffEe4/16 = 1/4 = 25% of the progeny will not have freckles AND will have closed eyebrows, ffee-----------------------------------------------
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envrionmental influences can determingwether a gene is expressed for some people that will be decisive in whether they develope a psychological disorder. this best illustrates the need for
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The environmental influences on gene expression best illustrates the need for research on epigenetics.
Genes have very prominent role in diseases which are affected by environmental factors. People suffer from anxiety and depression due to gene mutation, however such conditions are rare. Scientists are researching on the potential conditions which affect gene. Epigenetics is the field of scientific research which correlates the the behaviors and the environmental conditions which prominently describes the gene expression. However, epigenetic changes are reversible in nature and they do not change the DNA sequence in the body as it occurs during mutations due to radio waves which encounters the body. Epigenetic changes are modifications to DNA that regulate whether genes are turned on or off.
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Trackers uses 9000 meters in 30 minutes on a average how many meter trackers track each minute
Answers
Answer: it is 300
Explanation:
Which of the following is the most basic level of organization?
Tissue
Cell
Organism
Organ