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(1) (a) What is the critical path in drug development? (b) List the main stages inthe critical path of the development of a drug.(2) Explain the meaning of the terms (a) dosage form, (b) ELF, (c) telescoping indrug production, (d) excipient and (e) double blind trial.(3) Outline the chemical factors that need to be considered when scaling up aresearch synthesis to pilot plant scale.(4) Outline a possible production scale route for the preparation of the thromboxane analogue A.(5) Explain the differences between (a) preclinical and clinical trials and (b) PhaseI and Phase II trials.(6) What is a patent? Why is it necessary to patent drugs?
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