Quality Assurance Unit Faculty of Pharmacy Course Specifications 1- Basic Information: Course code: 446 Course title: STATISTICS, DRUG Year: 4th (New curriculum)/ SCREENING AND BIOLOGICAL EVALUATION Semester:4th (New curriculum)/ No. of contact hours/week ))بالنسبة لمرحلة البكالوريوس: 2/w Theoretical: 24 hrs Practical: 24 hrs 2- Course Goals: 1. Develop the knowledge gained by studying and understanding the pharmacology course and apply it for biological screening procedures of drugs. 2. Understand how to use some biological screening procedures to evaluate the potency (biological standardization ) of newly developed active compounds either natural or synthetic or even established drugs in comparison with existing standard drugs. 3. Develop the knowledge to screen and biologically standardize hormonally active compounds. 4. Learn various statistical procedures to analyze different data obtained from biological experiments. 5. Plan , design and conduct biological researches. 6. Develop presentation skills. 7. Able to be self learner for continuous improvement of professional knowledge and skills. 3- Intended Learning Outcomes of Course (ILOs): 1 Quality Assurance Unit Faculty of Pharmacy a. Knowledge and understanding After completing the course the student should be able to: a.1. That is relevant to biological screening basic pharmacology and standardization of drug activities. a.2. Various methods of biological screening of drug activities a.3. Principles of identification and standardization methods of pharmaceutical compounds using biological systems. a.4. Methods of biostatistical analysis. a.5. Interpretion of the mathematical results of biostatistical procedures b. Professional and Practical Skills After completing the course the student should be able to: b.1. Identify and / or standardize active substances from different origins using biological systems . b.2. Design appropriate biological screening and standardization experiments. b.3. Use basic pharmacological laboratory equipment safely and effectively. b.4. Explain the principles and limitations of practical techniques. c. Intellectual Skills After completing the course the student should be able to: c.1. Apply qualitative and quantitative biological methods for QC and bioassay of raw materials as well as pharmaceutical preparations. c.2. Select the appropriate methods of identifications , screening and standardization of active substances from different origins. c.3. Retrieve and select the proper statistical procedure for a 2 Quality Assurance Unit Faculty of Pharmacy given process. d. General and Transferable c.4. Indentify and classify the main screening procedure to various related and complementary tests to investigate other possible beneficial or adverse effects of agents or new drugs. c.5. Present the data correctly , with tables and graphs. c.6. Analyze and interpret experimental data as well as published literature. After completing the course the student should be able to: d.1. Skills Use numeracy , calculation and statistical methods as well as information technology tools. d.2. Work effectively in groups. d.3. Practice independent learning needed for continuous professional development. d.4. Adopt safety guidelines regarding animal handling. d.5. Implement writing and presentation skills. d.6. Demonstrate critical thinking problem solving and decision making abilities. 4- Course Content: 1. Biostatistics. 2. Introduction to screening procedures. 3. Screening and bioassay of various drug groups. 4. Bioassay of hormones. 3 Faculty of Pharmacy Quality Assurance Unit 5- Teaching and Learning Methods: 1. Lectures . 2. Laboratory work. 3. Assignments . 4. Reports and posters . 5. Round case discussions. 6. Web based search assignments. 6- Student Assessment: Methods of Assessment Weighting Assessment Schedule % Practical exam 30 7th and 14th week Written Exam 50 15th week Oral Exam 20 15th week 7- List of Textbooks and References: 1. Course Notes: Departmental lecture notes 2. Essential Books (Text Books): Pharmacological basis of therapeutics Goodman and 3. Recommended Books: Drug discovery and evaluation Vogel and Vogel latest Gilman latest edition edition 4. Periodicals, Web Sites: Pub med and science direct 8- Required Facilities for Teaching & Learning: 4 Faculty of Pharmacy Quality Assurance Unit 1. Personal Computer (available for each staff member), 2. Power Point Displayer (Data-Show); easy available for the usual lectures and Labs. 3. Lecture Hall 4. Computer Hall with enough devices and internet connection 5. Meeting rooms for office hours 6. Laboratories , appropriate instruments and experimental animals 9- Matrices of knowledge and skills: Topics Number of weeks Knowledge and understanding Professional and Practical Skills Intellectual Skills General and Transferable Skills Theor. Pract. 1. Introduction 2 2 a1 B2,b3 c1, c2 D4 2. biostatics 5 5 A4,a5 - C3,c5, c6 D1,d6 3. bioassay and screening of autonomic drugs 7 7 A1,a2 a3 B1,b4 C4 - 4. bioassay and screening of hormones 2 2 A1, a2 ,a3 B1,b4 C4 - 5. bioassay and screening of central nervous system 4 4 A1,a2,a3 B1,b4 C4 D2,d5,d3 6. bioassay and screening 5 5 A1,a2,a3 B1,b4 C4 - 5 Faculty of Pharmacy Quality Assurance Unit of cardio vascular drugs 7. bioassay and screening of autacoids 2 2 A1,a2,a3 B1,b4 C4 - Knowledge and understanding Professional and Practical Skills Intellectual Skills General and Transferable Skills A1,a2,a3,a4,a5 B1,b2 C1,c2 - 2. Laboratory work - B3,b4 C1,c2,c3,c4 D2,d4 3. assignments - - C5,c6 - 4. laboratory activities - - C3 D1,d3,D5,d6 Teaching and Learning Methods 1. lectures Student assessment methods Knowledge and understanding Professional and Practical Skills Intellectual Skills General and Transferable Skills A1,a2,a3,a4,a5 B1,b2 C1,c1,c3, c4 D1 - B1,b2 C1,c2 D3,d4 A1,a2,a3,a4,a5 B1,b2 C1,c2,c4 - 1. written exam 2. practical exam 3. oral exam 6 Faculty of Pharmacy Quality Assurance Unit Course Coordinator: Signature: Name: Dr Engy mohamad Head of Department: Signature: Name: Assistant. Prof. Dr Amany Ali Eissa Date: 29-11-2011 Academic year: 2010/2011 7