Question

Which of the following is essential for drug products to be considered bioequivalent and not just...

Which of the following is essential for drug products to be considered bioequivalent and not just chemically equivalent by the FDA?

They must have similar brand names.

They must have the same active ingredient or ingredients.

They must have similar dosages.

They must have the same route of administration.

They must have similar rates of release into the body.

Homework Answers

Answer #1

ANSWER:-

OPTION:-E

They must have similar rates of release into the body...

If their rates and extent of absorptiont do not show a significant difference from the rate and extent obsorption of the reference drug when administered at same molar dose of therapeutic ingradient under similar experimental conditions either in singlesor multiple doses are said to be bioequivalent and not just chemically equivalent by FDA

Please do leave a like for my answer

Thank you

All the best

Know the answer?
Your Answer:

Post as a guest

Your Name:

What's your source?

Earn Coins

Coins can be redeemed for fabulous gifts.

Not the answer you're looking for?
Ask your own homework help question
Similar Questions
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response...
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: In response to the demand for alcohol-based hand sanitizers and their active ingredient, alcohol, certain entities that are not currently regulated by the FDA as drug manufacturers have requested guidance on the preparation and distribution of alcohol for incorporation into hand sanitizer products for the public’s use. The FDA issued another guidance for industry about hand sanitizers, Temporary Policy...
Which of the following statements about the principles of drug therapy is INCORRECT? (a) A narrow...
Which of the following statements about the principles of drug therapy is INCORRECT? (a) A narrow therapeutic index means the difference between a therapeutic dose and a toxic dose is small (b) The onset of action of a drug is a measure of the time taken for the concentration to enter the therapeutic range (c) The duration of action of a drug is a measure of the time period during which the concentration is within the therapeutic window (d) When...
Which of the following are considered to be essential parts of species formation (select all that...
Which of the following are considered to be essential parts of species formation (select all that are correct) The ancestral or starting species is in fact a reproductively isolated community (a single population) Barrier formation - subgroups are divided and isolated reproductively Divergence - different selection pressures operate on the divided subgroups producing different rates of success for various phenotypes If the barrier were to disappear (secondary contact) the groups would not be an interbreeding community - they have become...
In which of the following cases is a measure considered reliable? The Balance Tracking System (BTrackS)...
In which of the following cases is a measure considered reliable? The Balance Tracking System (BTrackS) force-plate captures the center of pressure (a measure of postural control) of an older adult in an experimental session of 3 trials with consistent results A new motion capture system software had highly variable results measuring angular velocity of the elbow joint in 2 trials under similar conditions A measuring tape essential for measuring the distance required to accurately place a marker 4 feet...
Randy recently received a used mobile phone which he won through an eBay auction bid. It...
Randy recently received a used mobile phone which he won through an eBay auction bid. It turns out the mobile phone was sold by a friend who lives in the same apartment complex. Which of the following is correct regarding this transaction? The purchase is considered a retail purchase but Randy’s friend is not considered a retailer. The purchase is considered a retail purchase and Randy’s friend is considered a retailer. The purchase is not considered a retail purchase and...
3.   Which of the following would be LEAST LIKELY to be considered a long-run determinant of...
3.   Which of the following would be LEAST LIKELY to be considered a long-run determinant of consumption? (a) an external shock to the financial system; (b) attitudes toward thrift; (c) the availability and cost of credit; (d) asset holdings of households and businesses. 17.   When looking at the equation of exchange, we note that P times Q increased by 6%. Accordingly, M times V: (a) likely experienced an increase of 6% split between money supply growth and velocity; (b) decreased...
When is a hypothesis considered scientific? a. when it is based on something other than observation...
When is a hypothesis considered scientific? a. when it is based on something other than observation b. when it can be tested and is refutable c. when it relies on anecdotal evidence d. when it relies on mystical explanations e. All hypotheses are considered scientific until experiments determine otherwise. 3. Of the following, which is the earliest step in the scientific process? a. generating a hypothesis b. analyzing data c. conducting an experiment d. drawing a conclusion e. developing a...
When estimating the C-value of an organism, which of the following would not be considered? The...
When estimating the C-value of an organism, which of the following would not be considered? The non-coding regions of the genome The mitochondrial genome The coding regions of the genome The size of the entire haploid genome is estimated for C-value When estimating the G-value of an organism, which of the following would not be considered? Mitochondrial genes Protein coding regions of the genome The size of the entire haploid genome is estimated for G-value Non-coding parts of the genome...
Multiple choice questions: Sucrose is an oligosaccharide made up of which one of the following sugars?...
Multiple choice questions: Sucrose is an oligosaccharide made up of which one of the following sugars? glucose and glucose glucose and fructose maltose and glucose starch and glycogen deoxyribose and ribose There are different types of microscopes that can be used to provide information about cells. Which type of microscope is used for the observation of living cells? scanning electron microscope light microscope transmission electron microscope To move solutes like amino acids into a cell by active transport, the cell...
You are the Chief Marketing Officer (CMO) for a consumer products company. Your company just launched...
You are the Chief Marketing Officer (CMO) for a consumer products company. Your company just launched a new brand of hair care products targeted at young girls between the ages of 14 – 19. You spent millions of dollars researching the habits of girls in this age bracket, what is important to them about making their hair care product decisions and the views of competing products and are confident that, with the right IMC plan, the new line will be...