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Question 1:
Describe upon CMC information about drug substance to be submitted to IND for Phase 3 studies.
Definition of CMC
Explain about CMC information about drug substance to be submitted to IND for Phase 3 studies-General Information, Manufacturers,
Description of Manufacturing Process and Process Controls, Controls of Critical Steps and Intermediates, Characterization, Control of Drug Substance, Reference Standards or Materials, Container Closure System, Stability, Control of Materials.
Question 2:
Prepare a scientific review required in US for the medical devices for which insufficient information exists to assure safety and effectiveness.
A sample of yeast cells was serially diluted 1/10 five times then serially diluted 1/3. the number of yeasts was338 yeasts per ml. what was the original concentration? Please show
Inter specific Incompatibility This type of incompatibility is characterized by the prevention of fusion of gametes between members of different species. The incompatibility
Androgenic haploids Androgenic haploids of some species, such as wheat, mustard and tobacco, can also be raised through isolated microspore pollen culture (Pollen cultures). I
To be in good health, we need to take food. Energy is provided by food to carry out activities in day to day life. In the same way, a diabetic patient also needs healthy food for e
Q. What are arterial vessels, arterioles and arteries? Arterial vessels are every blood vessel that carries blood from the heart to the tissues, arterioles and Arteries are art
What is omnispective classification
How much of a 10% w/v of nacl can be made using 30g of nacl? Please show all steps.
levels of biodiversity
Entropy is the degree of disorder in a system. As the energy is transferred from one form to another form, some of it is lost as heat; as the energy decreases, the disorder in sys
state 5 advantages and disadvantages of protozoa
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