Current Pharmaceutical Aspects of Industry - M.Pharm Previous Paper Nov 2012

M Pharm Il Semester Regular & Supplementary Examinations, November 2012

CURRENT PHARMACEUTICAL ASPECTS OF INDUSTRY

(Pharmaceutics)

Time: 3 hours                                                                                                  Max Marks: 60

Answer any FIVE questions
All questions carry equal marks

(a) Write the principle involved in the drying and explain in detail about:
(i) Freeze dryer
(ii) Fluidized bed dryer.

(b) Explain the principle involved in sterilization of auto clave and its applications in moist heat sterilization.

2.  Explain the various packaging systems and also advances in pharmaceutical packaging compared with conventional packaging techniques.

3. Write in detail about stability protocols of pharmaceutical preparations as per ICH guidelines.

4.  (a) Explain the different types of industrial hazards due to fire accidents, mechanical and chemicals

(b) What are preventive steps to be taken to control the industrial hazards?

5.  Define intellectual property rights and write about regulatory affair procedures with reference to Indian and United States norms.

6.  What types of regulatory requirements are to be followed on animal and human studies for drug development requirements for new drug approval?

7.  (a) Explain production control and safety precautions for radio pharmaceuticals.

(b) Discuss the applications of radio pharmaceuticals

8 Write short notes on:
(a) Regression and correlation
(b) Test of significance and t-test.
(c) Statistical quality control charts.
(d) Multiple regressions and laws of probability