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PHEN-601
SYLLABUS & POLICIES
Marc Bernhardt
Fall 2015
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FULL DISCLOSURE
THE OPINIONS EXPRESSED BY ME ARE NOT
NECESSARILY THE OPINIONS OF THESE
ORGANIZATIONS. 3
THE COURSE NOTES ARE AVAILABLE AT NJIT’S MOODLE 2
WEBSITE:
http://njit2.mrooms.net/
4
Check the NJIT Calendar !
www.njit.edu/registrar
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PhEn 601
VALUE PROPOSITION
• EXPAND YOUR HORIZON
• MANDATORY
– CERTIFICATE PROGRAMS
– DEGREE PROGRAMS
• GET YOU THROUGH THE INTERVIEW
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OUR TIME HAS VALUE
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THE PRODUCTS HAVE VALUE
8 At a retail pharmacy, this product costs more than gold!
LIVES HAVE VALUE OUR PRODUCTS SAVE LIVES
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YOU PK & PD
REGULATIONS
FACILITIES
DOSAGE
FORMS
HISTORY
CLINICAL TRIALS
PLACEBO
S.A.R.
BIOLOGY
SERUM CONC. TABLETS
CAPSULES
O.C.G.
TDDS
WATER
EQUIPMENT
UTILITIES
CLEANROOMS
YOU and PhEn 601
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GRADE CALCULATION
• Quiz 1 15%
• Midterm exam 35%
• Quiz 2 15%
• Final exam 35%
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SYLLABUS
TENTATIVE
SYLLABUS.
CHANGES MAY
OCCUR AND WILL
BE ANNOUNCED
IN CLASS OR VIA
MOODLE.
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SYLLABUS
Week Date Topics Ansel
Chapter(s)
1 Sep. 8 Introduction
History
Law
1
2 Sep. 14 No Class
3 Sep. 21 Drug Development
Clinical Trials
Placebo
2
4 Sep. 28 Receptors
FDA, cGMP
Controlled Substances
3
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SYLLABUS
Week Date Topics Ansel
Chapter(s)
5 Oct. 5 Packaging, Labeling,
Advertising
Goal Drug, ADME
Drug Discovery, Drug Names
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6 Oct. 12 Quality Assurance
Focus on a Disease
QUIZ 1 or HOMEWORK
7 Oct. 19 Dosage Forms & Physics
Stability, Absorption
Clearance, Solid Dosage Forms
5,6,7,8,9
8 Oct. 26 MIDTERM
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SYLLABUS
Week Date Topics Ansel
Chapter(s)
9 Nov. 2 Ointment, Creams, Gels
TDDS, Pharma
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10 Nov. 9 Sanitary design,
Water purification,
Reverse Osmosis, Distillation
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11 Nov. 16 Suppositories,
Solutions,
QUIZ 2 or HOMEWORK
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12 Nov. 23 Validation,
Disperse Systems.
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SYLLABUS
Week Date Topics Ansel
Chapter(s)
13 Dec. 7 Parenterals,
Biologicals,
Risk
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14 Dec. 14 Facility design,
Opthalmics,
Radiopharmacy,
Biotechnology,
Novel drug delivery
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Dec. 21
Final Exam
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