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1. Discuss the importance of data recording and management in clinical research. What are some of the pros/cons of electronic data capture systems?
2. After reading the ICH E2D guidance, discuss the importance of pharmacovigilance in the life cycle management of medicinal products for human use
3. Pretend you are working for a pharmaceutical company with a drug that is about to finish Phase IIB clinical trials. This means it is time for your company to have potential meeting(s) with the FDA and you have been tasted of requesting such FDA meeting(s).
a) Summarize the different types of FDA regulatory meetings and discuss the meetings that you would request for further clinical development (i.e. Phase III trial) of the Company's investigational medicinal product.
In the formation of smog, nitrogen and oxygen gas react to form nitrogen dioxide. How many grams of NO2 will be produced when 2.0L of nitrogen at 840 mmHg and 24°C are completely reacted
The order of skunks is caused by chemical compounds called thiols. These compounds, of which butanethiol(C4H10S) is a representative example, can be deodorized by reaction with household bleech (NaOCl) according to the following equition:
Suppose you have just added 200.0 ml of a solution containing 0.5000 moles of acetic acid per liter to 100.0 ml of 0.5000 M NaOH. What is the final pH? The Ka of acetic acid is 1.77 x 10^-5
question covalent modification of enzymes is an important means of regulation. explain the steps by which
A 1.20 gram sample of dry ice is added to a 755mL flask containing nitrogen gas at a temperature of 25.0 degrees Celsius and a pressure of 725 mmHg. The dry ice is allowed to sublime and the mixture is allowed to return to 25.0 degrees Celsius. wh..
An unknown compound B has the melting point 112.5-114 degrees C. It is suspected that B is either X or A, each compound having reported mps of 115degreesC. Assuming B is X, indicate the mp range (give actual values) for the Melting points
Draw the crossed aldol condensation product formed between benzaldehyde and acetone
Relate cause and effect: Solid table salt doesn't conduct electric current. How does dissolving salt in water permit electric current to flow
A 2L steel vessel is filled with 1.5atm of He gas at 25 degrees Celsius. Then 5 grams of O2 gas are added to the vessel at constant temperature. Determine the resulting total pressure in the vessel.
Explain what are the differences between physical and chemical reactions in chemistry
Comment on the following observation: in its complexes, Co(III) forms strong bonds to O- and N- donor ligands, moderately strong bonds to P- donor ligands
why should gloves be worn when handling white phosphorus - why are firefighters advised to use dry sand rather than wet sand to extinguish a small red phosphorus fire?
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