M.Pharm 1st semester Regular & Supplementary Examinations, February 2016
BIO STATISTICS, INTELLECTUAL PROPERTY RIGHTS & REGULATORY AFFAIRS
(Common to all)
(For students admitted in 2011. 2012, 2013, 2014, 2015 only)
Time: 3 hours Max Marks: 60
Answer any FIVE questions
All questions carry equal marks
1 write in detail about principles and applications of z. t and Chi-squire tests in medical and pharmaceutical research.
2 Explain about
(a) Collection and organization of data with examples.
(a) Collection and organization of data with examples.
(b) Uses and construction of R, P. nP and chart ‘S’.
3 Write about
(a) Measures of central tendency and dispersion.
(b) Analysis of data and their applications of CRD, RBD, LSD
4 (a) Discuss briefly about principles and applications of factorial experiments.
(b) Differentiate about on rank sum test and Kruskal Wallis test.
5. write in detail about scope, objectives, sources and applications of patent, patent information and patent processing.
6 . Explain about
(a) Drugs and Cosmetic Act 1940 and rules 1945.
(b) International and regional agreements
7. Discuss briefly about requirements and guidelines of GMP. Add a note on handling and maintenance including electronic documentation
8. (a) write short notes on objectives and guidelines of USFDA and WHO
(b) Describe about NDA and ANDA
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