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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.
why is epidermis peeledsuggest why a marine amoeba does not have a contractile vacuole
Empirical validity of test procedures Reitan's great concern has always been with the empirical validity of test procedures. Such validity can only be established by the collec
What is Simple Transposition in Neonates ? A baby with this malformation needs to be operated without delay. A very cyanosed infant will require palliation by balloon arteries
How Bone density affect Osseointegration The most important bone property is density which is influenced by factors such as patient age and genetics. Higher density bones have
What is Resection and Primary End to End Anastomosis ? For neonates and infants the best operation is resection of coarctation and primary end-to-end anastomosis. With the baby
what is biodiversity?
Advice on Discharge : Patients are allowed to go home on 8th or 9th day. It could be even earlier after off pump coronary artery surgery (OPCAB). They should gradually increase t
(a) What are the two main pollutants that contribute to acid rain? (b) Where do these pollutants come from? (c) What direct or indirect effect is 'acid rain
What are the androecium and the gynoecium? What are the other structures of flowers? Androecium is the set of male reproductive structures of flowers. It comprehends the stamen
Discuss in short about soil " The collection of natural bodies in the Earth's surface, in places modified or even made by man of Earthy materials, containing living matter an
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