1. GMPs only apply to new drugs: True or False 2. Which of the following supports generic drug...

1. GMPs only apply to new drugs: True or False

2. Which of the following supports generic drug approvals? A. Premarket Notification B. Abbreviated NDA C.New Drug Application D.None of the above

21 CFR Part 210 is one of two sections of the regualtions pertaining to GMPs. True or False

he following are types of validation related to Good Manufacturing Practices and other regulations (select all that apply): A Bioequivalent B. Process C. Informed Consent D. Computer System E. All of the Above

Solutions

Expert Solution

1. GMPs only apply to new drugs: False

GMP strands for Goods manufacturing practice. It is a quality control system which ensures all pharmaceutical products are well tested before come to the market and it is safe to use. Some food products, diagnostics also have GMP.

B. Abbreviated NDA support generic drug approvals.

Generic drug application termed as Abbreviated new drug application . Generic drugs is a drug that is made up of a same chemical substances of a patented drug. Clinical trials is not necessary for generic drug . So it is termed as Abbreviated.

21 CFR Part 210 is one of two sections of the regualtions pertaining to GMPs __ true.

Part 210 is for current good manufacturing practice in manufacturing, processing ,packing of drugs.

Part 211 is about Current GMP for finished pharmaceutical.

All of the above are the types of validation related to Good Manufacturing Practice and other regulations.

gladiator answered 1 year ago

Next > < Previous

Related Solutions

1. True or False: Confidence intervals can only be calculated for means. True False SAVE 2....

1. True or False: Confidence intervals can only be calculated for means. True False SAVE 2. Suppose a sample of 200 barrow-wights (wraith-like creatures that feed on the life force of the living) yields a sample mean of 6.2 living beings consumed per day. Assuming a standard error of 1.7, what would the upper bound of a 95% confidence interval be? SAVE 3. Using the same ridiculous survey data from the previous question, what would the lower bound of a...

1. All mutations are harmful. a) True b) False 2. Which of the following is TRUE...

1. All mutations are harmful. a) True b) False 2. Which of the following is TRUE about mutations? a) Mutations are more likely to occur if they result in a useful trait b) Mutations can be inherited. c) Mutations only occur during DNA replication d) Mutations do not occur in organisms that reproduce asexually 3. Which of the following would increase the chances of getting a mutation? a) Wearing a hat outside b) Putting sunscreen on your face and arms...

A prescription drug manufacturer claims that only 10% of all new drugs that are shown to...

A prescription drug manufacturer claims that only 10% of all new drugs that are shown to be effective in animal tests ever pass through all the additional testing required to be marketed. The manufacturer currently has eight new drugs that have been shown to be effective in animal tests, and they await further testing and approval. You are not allowed to use PHStat4 for this question. Show your calculations clearly by labeling them properly so that it is clear to...

Answer the following true/false 1.A permanent mortgage is one on which interest only has to be...

Answer the following true/false 1.A permanent mortgage is one on which interest only has to be paid 2.A pro‑forma income statement is an income statement calculated on a cash basis 3.The best way to evaluate feasibility study financial projections is to convert the projected cash flow figures using net present value (NPV) or internal rate of return (IRR). 4.The concepts of financial management are basically the same for both profit and non-profit organizations 5.Funds raised through proper financial management should...

1) Imports are a negative to an economy. True False 2) Which of the following had...

1) Imports are a negative to an economy. True False 2) Which of the following had a negative impact on trade? Increased Trade agreements Reduced trade barriers Improved Transportation None of these 3) Globalization is a modern concept that has proponents and opponents though most people have seen some positive benefits. True False 4) Which of the following tends to have a negative effect on trade. (Pick all correct answers) Dictators War Tarriffs Nationalization New Technology

1.Tier 2 suppliers are primary suppliers to manufacturers. True or False? 2. Which of the following...

1.Tier 2 suppliers are primary suppliers to manufacturers. True or False? 2. Which of the following statements is TRUE regarding tier 1 suppliers? A. Tier 1 suppliers are the starting point of a supply chain. B. Tier 1 suppliers are the primary suppliers to tier 2 suppliers. C. Tier 1 suppliers are the primary suppliers to retailers. D. Tier 1 suppliers are the primary suppliers to manufacturers. 3. Company A fails to satisfy some 15% of customers’ orders last month....

1) Only 1% of the filtrate leaves the body as urine. True or False 2) Perineal...

1) Only 1% of the filtrate leaves the body as urine. True or False 2) Perineal structures in the female reproductive system include the [a] and the [b] 3) The ---------- is the main processor of drugs in the body. answer all three questions please. just the right answers only. thanks

Identify which of the following statements is true and which is false. 1) _________ For a...

Identify which of the following statements is true and which is false. 1) _________ For a set of numerical data, if the mean is larger than the median, this is evidence of right-skew. 2) _________ Negative values of the standard deviation indicate that the set of values is even less dispersed than would be expected by chance alone. 3) _________ For a set of numerical data, if the mean and the median are of equal value, this is evidence of...

In a study to evaluate drug efficacy, the manufacturer of a new type of generic drug...

In a study to evaluate drug efficacy, the manufacturer of a new type of generic drug for treating a disease wants to investigate the effectiveness of this generic drug as compared to the traditional brand name drug, At the present time, the brand name drug is the only approved treatment for the disease. Patients diagnosed with the disease have low concentration of a specific factor in their blood. Treatment with the brand name drug will result in an increase in...

Which of the following are TRUE? Select all that apply. A probability of 1 is the...

Which of the following are TRUE? Select all that apply. A probability of 1 is the same as a probability of 100% The difference between interval and ordinal data is that interval data has a natural zero. If you are doing a study and the population is Americans, the easiest type of study to run would be a simple random sample. If your population is 80% female and your sample is 60% male, there is undercoverage bias. In order to...

Subjects