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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.
Q. Acute diarrhoea? It must be evident from the table above that acute diarrhoea generally occurs in association with infections, poisons and drugs. Chronic diarrhoea on the ot
Is memory loss an early sign of Alzheimer's disease? A. Memory loss is one of the earliest symptoms of Alzheimer's disease and other kinds of dementia however occasional forget
What would happen to the rate of photosynthesis in C3 plants if the CO2 concentration level almost doubles from its present level in the atmosphere?
What is Sports Nutrition? Sports nutrition is a discipline which applies principles derived not only from nutritional but also biochemical and physiological scientific knowled
If the chemical formula of a substance is C17 H 31 COOH, what can you tell about the identity and amounts of elements in the molecule? Can someone please explain me this?
Q. How does the sexual arousal mechanism in women facilitate fecundation? During sexual arousal in women the vagina secretes substances to neutralize its acidity thus allowing
SCOPE OF BIOLOGY- Present century is witnessing explosion of information in modem biology directly related to life and health. Issues like global warming, pollution, populat
ORIGIN (1) From Pro plastid (2) Division (3) Endosymbiotic origin from a cyanobacterium
The Accident or Incident Theory - Accident Causation Peterson when reiterating the significance of human factors added such factors as ergonomic traps, the decision to err and
Delimitation and Limitation: There may be many aspects of the problem that need to be explored, but it is difficult to cover all aspects in a single research study bec
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