PHEN-601
NOTES
POLICIES AND REFERENCES
Dr. W. Bruce Eckman
WBE Consulting,Inc
INSTRUCTOR EMAIL:
beckman@torcon.com
(do not use njit email 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 emailed( 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:
732-704-9800 x226
• INSTRUCTOR’S E-MAIL ADDRESS:
beckman@torcon.com DO NOT USE NJIT EMAIL ADDRES
• INSTRUCTOR’S OFFICE HOURS: OFFICE HOURS ARE
BEFORE EACH CLASS BY APPOINTMENT.
• STUDENTS MAY EMAIL 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 EMAIL 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 exam
• Final exam
• Quiz 1
• Quiz 2
35%
35%
15%
15%
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!
www.njit.edu/registrar
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 #2
SEP.13
OVERVIEW OF DRUG DISCOVERY, DEVELOPMENT,
ADME, CLINICAL STUDIES
• WK #3
SEP.20
FOCUS ON A DISEASE
DOSAGE FORMS OVERVIEW, PREFORMULATION
SERUM CONCENTRATION,
SYLLABUS
• WK #4
SEP.27
cGMP’S & CFR
SOLID DOSAGE FORMS, PARTICLES & GRANULES
MODIFIED/EXTENDED RELEASE, IVIVC’S
QUIZ#1
• WK #5
OCT.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 #13
NOV.29
CLEANROOMS, FACILITY DESIGN,
RADIOPHARMACY
OPTHALMICS,
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.
VAN HOUTEN LIBRARY
http://www.library.njit.edu/