P H E N -601 NOTES POLICIES AND REFERENCES Dr. W. Bruce Eckman WBE Consulting,Inc

INSTRUCTOR (do not use njit address)

With All Due Respect and Thanks To Professors Joseph Manfredi and Marc Bernhardt for the use of many of these slides.

COURSE DESCRIPTION FROM THE NJIT eCATALOG “This course provides an overview of the pharmaceutical industry, including basic information about drug discovery and development, FDA requirements and approval processes, drug dosage forms, and the role of key operational units in drug manufacturing processes. This course enables the students to: understand the role of the pharmaceutical industry in the global market and its implications; learn the fundamentals of the drug development cycle and the investment required to bring a drug to market; learn the most important drug manufacturing processes and the key elements of dosage formulation.”

CLASS NOTES THE COURSE NOTES CAN BE FOUND AT: will be ed( unless limited by size)

CLASS NOTES READ THE SUPPLEMENTARY READINGS !!!

ATTENDANCE EVEN THOUGH ATTENDANCE AND CLASS PARTICIPATION ARE NOT MANDATORY, THEY MAY BE USED AS POSITIVE FACTORS WHEN ASSIGNING FINAL GRADES.

PhEn601 INSTRUCTOR’S TELEPHONE: x226 INSTRUCTOR’S ADDRESS: DO NOT USE NJIT ADDRES INSTRUCTOR’S OFFICE HOURS: OFFICE HOURS ARE BEFORE EACH CLASS BY APPOINTMENT. STUDENTS MAY AT ANY TIME OR PHONE DURING REGULAR BUSINESS HOURS. RESPONSES WILL BE HANDLED AS QUICKLY AS POSSIBLE, SUBJECT TO SCHEDULING, TRAVEL AND OTHER PRIOR COMMITMENTS. PHONE CALLS SHOULD BE LIMITED TO EMERGENCIES ONLY. COURSE DAY AND TIME: TUESDAY 6:00 – 9:05 P.M.

HOUSEKEEPING WE WILL BE USING YOUR ADDRESS AS GIVEN TO ME TONIGHT AS NEEDED TO COMMUNICATE WITH THE CLASS. CHECK THIS REGULARLY. GUEST LECTURERS WILL BE SCHEDULED AS AVAILABLE AND THE CLASS SCHEDULE ADJUSTED ACCORDINGLY. OBTAIN AND BEGIN READING TEXT (CORRECT EDITION). 30 MINUTE POLICY FOR INSTRUCTOR ABSENCE CLASS BREAKS WILL BE DISCUSSED AND A FORMAT SELECTED, HOWEVER THIS WILL REMAIN AT THE INSTRUCTOR’S DISCRETION.

GRADES Grading Policy: Midterm exam35% Final exam35% Quiz 115% Quiz 215% Important Note: The average of the midterm and the final exam grades must be >70% in order to receive a passing grade for the course.

GRADES COURSE FINAL GRADE: A TENTATIVE GUIDELINE FOR THE ASSIGNMENT OF FINAL GRADES IS PROVIDED BELOW:

GRADES The grade of “D” is not assigned to students taking graduate courses. Please remember that this is only a guideline designed to help the students understand how they are performing in the course.

GRADES Make-up exams will only be given to students who cannot attend the regular exam time, and only under documented and extraordinary circumstances. In any case, no student will be allowed to a take a make-up exam unless he/she has the prior consent of the instructor. If a student fails to take a quiz or an exam as scheduled, the grade will automatically be zero.

EXAMS A CALENDAR OF THE EXAMS IS INCLUDED IN THESE NOTES. ALL EXAMS ARE TYPICALLY 3 HOURS LONG, UNLESS OTHERWISE STATED. ALL EXAMS ARE OPEN BOOK AND OPEN NOTES, UNLESS OTHERWISE ANNOUNCED. THE FINAL EXAM WILL INCLUDE ALL MATERIAL COVERED THROUGHOUT THE COURSE (ALTHOUGH THE MAIN EMPHASIS OF THE EXAM MAY BE ON THE MATERIAL COVERED AFTER THE MIDTERM EXAM).

QUIZZES A CALENDAR OF THE QUIZZES IS INCLUDED IN THE COURSE OUTLINE BELOW. QUIZZES ARE TYPICALLY 1 HOUR LONG UNLESS OTHERWISE STATED. QUIZZES MAY BE OPEN OR CLOSED BOOK AND NOTES. FORMAT WILL BE ANNOUNCED. QUIZZES WILL TYPICALLY COVER MATERIAL FROM IMMEDIATELY PRECEDING CLASSES.

QUIZZES MAKE-UP QUIZZES WILL ONLY BE GIVEN IF APPROVED IN ADVANCE FOR DOCUMENTED AND EXTRAORDINARY CIRCUMSTANCES. CLASS ATTENDANCE: AS FOR ALL GRADUATE COURSES AT NJIT, ATTENDANCE IS NOT MANDATORY, BUT STRONGLY RECOMMENDED. EXPERIENCE SHOWS THAT STUDENTS WHO DO NOT REGULARLY ATTEND CLASS TYPICALLY PERFORM POORLY IN THE COURSE. IN ADDITION, DISCUSSIONS AND MATERIAL PROVIDED BY GUEST LECTURERS WILL NOT BE COVERED IN THE NOTES. IN ANY CASE, STUDENTS ARE RESPONSIBLE FOR ALL MATERIAL COVERED IN CLASS.

Check the NJIT Calendar for Important Dates!

SYLLABUS THE FOLLOWING PAGES CONTAIN A TENTATIVE SYLLABUS. CHANGES MAY OCCUR AND WILL BE ANNOUNCED IN CLASS.

SYLLABUS WK #1 SEP.6 INTRODUCTION TO PhEn BY PROFESSOR ARMENANTE REMEDIES & PHARMACEUTICALS – PAST & PRESENT FOOD, DRUG & COSMETIC ACT WK #2SEP.13 OVERVIEW OF DRUG DISCOVERY, DEVELOPMENT, ADME, CLINICAL STUDIES WK #3SEP.20 FOCUS ON A DISEASE DOSAGE FORMS OVERVIEW, PREFORMULATION SERUM CONCENTRATION,

SYLLABUS WK #4SEP.27 cGMP’S & CFR SOLID DOSAGE FORMS, PARTICLES & GRANULES MODIFIED/EXTENDED RELEASE, IVIVC’S QUIZ#1 WK #5OCT.04 SEMI-SOLID PRODUCTS - OINTMENTS,CREAMS,&GELS TRANSDERMAL PRODUCTS INDUSTRY OVERVIEW PHRMA WK #6 OCT.11 SANITARY DESIGN MATERIALS & FINISHES,EQUIPMENT DESIGN INSPECTION & QUALITY & PASSIVITY

SYLLABUS WK #7 OCT.18 PHARMACEUTICAL WATER SYSTEMS RO, DI, DISTILLATION WK #8 OCT.25 MIDTERM EXAMINATION WK #9 NOV.1 SUPPOSITORIES, SOLUTIONS, VALIDATION WK #10 NOV.8 DISPERSE SYSTEMS WK #11 NOV.15 PARENTERALS QUIZ#2

SYLLABUS WK #12 NOV.22 BIOLOGICALS WK #13NOV.29 CLEANROOMS, FACILITY DESIGN, OPTHALMICS, RADIOPHARMACY WK #14 DEC.6 SEMESTER REVIEW/ SELECTED SPECIAL TOPICS WK #15 DEC.20 FINAL EXAM

FDA.GOV FDA.GOV has a wealth of information that is designed for both the general public and special groups (such as the regulated industries). FDA.GOV gives insights into the FDA’s current actions, priorities, and thought processes.

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