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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. Concerning enzymatic reactions, how dissimilar are the graphic curve of the variation of the speed of a reaction as function of substrate concentration and the curve of variatio
Explain the Superficial Minor Burns? Superficial minor bums are immersed immediately in cool water if possible. The burn is carefully cleaned to prevent infection. If dirt is d
Autotomy and Regeneration Shedding of body parts in self-defense to avert the attention of the predator-enemy or in any other emergency is a type of autotomy (auto: self, tom
Economic importance of obelia
Neurons - Nervous System Although neurons occur in a great variety of sizes and morphological forms, they have a basic plan of structure representing certain common characteri
Which of the following best describes why Okazaki fragments are not observed in PCR? A. DNA primase is used for the entire reaction therefore eliminating the production of Okaz
Explain the organisation of the intensive care unit? The following kinds of professional groups are required in the day to day functioning of a modern intensive care unit: Th
Explain Theory or Principle of Gram Staining of Bacterial Cultures? Foods are rich in various nutrients and can support the growth and survival of microorganisms. The microbial
Explain the Ebb-Phase of Stress Response? This occurs immediately following injury and lasts for approximately 24-hours. The so-called ebb phase, which is the early phase of th
In the time of Darwin the results of Mendel's research on biological inheritance had not been published, Genetics was not yet developed, neither DNA nor the concept of genetic muta
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