1. P H E N -601 SYLLABUS M. Bernhardt 1

2. Marc Bernhardt MJB27@NJIT.EDU 201.847.631027@NJIT.EDU 2

3. PhEn 601 VALUE PROPOSITION EXPAND YOUR HORIZON MANDATORY –CERTIFICATE PROGRAMS –DEGREE PROGRAMS GET YOU THROUGH THE INTERVIEW 3

4. 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 4

5. 5

6. ATTENDANCE ATTENDANCE IS AT YOUR DISCRETION, WHETHER IN NEWARK OR DISTANCE LEARNING. CLASS PARTICIPATION MIGHT HELP WITH BORDERLINE GRADES NOTES & LECTURES COVER MATERIAL THAT IS NOT IN THE TEXTBOOK YOU ARE A GROWN-UP. 6

7. SYLLABUS TENTATIVE SYLLABUS. CHANGES MAY OCCUR AND WILL BE ANNOUNCED IN CLASS OR VIA EMAIL. 7

8. SYLLABUS WeekDateTopicsAnsel Chapter(s) 1Sep 8Introduction History Law 1 2Sep 15Drug Development Clinical Trials Placebo 2 3Sep 22Receptors FDA, cGMP Controlled Substances 3 4Sep 29Packaging, Labeling, Advertising Goal Drug, ADME Drug Discovery, Drug Names 4 8

9. SYLLABUS WeekDateTopicsAnsel Chapter(s) 5Oct 6Quality Assurance Focus on a Disease QUIZ 1 6Oct 13Dosage Forms & Physics Stability, Absorption Clearance 5 7Oct 20Solid Dosage Forms6,7,8,9 8Oct 27MIDTERM 9

10. SYLLABUS WeekDateTopicsAnsel Chapter(s) 9Nov 3Ointment, Creams, Gels TDDS Pharma 10 11 10Nov 10Sanitary design Water purification Reverse Osmosis, Distillation 11Nov 17Suppositories Solutions QUIZ 2 12 13 12Nov 24Validation Disperse systems14 10

11. SYLLABUS WeekDateTopicsAnsel Chapter(s) 13Dec 1Parenterals Biologicals Risk 15 16 14Dec 8Facility design Opthalmics, Radiopharmacy Biotechnology Novel drug delivery 17 18 19 20 15Dec 15Final Exam 11