Title

Time- Room

Dates

Instructor

Crn

Notes

5408. Pharmacoeconomics (101)

6:00 pm – 9:30 pm Tuesdays

Jan 22, 29, Feb 5, 19, 26, Mar 4, 11, 18, 25, Apr 2.  Make-up, if needed, Apr 8, 15 or 22. No class Feb 12 (weather cancellation).  Meets 10 times plus final exam

Heidi Thompson Waters, Ahmad Naim

040-784

Formerly Pharmaceutics 480.
Not open to students who have taken Pharmaceutics 480.

Required text:  Principles of Pharmacoeconomics,
J. L. Bootman, R.J. Townsend, W.F. McGhan. 3rd ed.

5451.  Statistical Quality Control (101)

8:30 am – 3:00 pm Sundays (1/2 hr lunch)

Jan 20, Feb 3, 17, Mar 2, 16, Apr 6.  Make-up, if needed, Apr 20.  Meets 6 times.

Rich Bigg

092-244

Formerly Pharmaceutics 451.  Not open
to students who have taken Pharmaceutics 451.

Required text:  Introduction to Statistical
Quality Control, 5^th ed., Douglas Montgomery, Wiley.

5459. Drug Development (101)

7:00 pm – 10:00 pm Thursdays: 

Jan 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3, 10.  Make-ups, if needed, Apr 17, 24, or May 1.  Meets 12 times plus final exam.

Frank DeLuccia 

009-320

Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

Required text:  New Drug Development:  A Regulatory Overview, Mathieu, 7th ed, 2005, (ISBN: 1-882615-72-7).

5459. Drug Development (102)

5:30 pm – 8:30 pm Mondays

Jan 28, Feb 4, 11, 18, 25, Mar 3, 10, 17, 24, 31, April 7, 14.  Make-ups, if needed, April 21 or 28.  Class meets 12 times plus final exam.

Daniel Walsh

069-111

Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459

Required text: New Drug Development:  A Regulatory Overview, Mathieu, 7th ed, 2005,
(ISBN: 1-882615-72-7) AND Drugs from Discovery to Approval, Ng, 2004, (ISBN: 0-471-60150-0)
AND The Great Influenza-The Epic Story of the

Deadliest Plague in History, John Barry, Penguin, 2004-

ISBN-0-14-303448-0.

5459. Drug Development (103)

6:00 pm – 9:30 pm Wednesdays

Jan 23, 30, Feb 6, 20, 27, Mar 5, 12, 19, 26, Apr 2.  Make-up, if needed, Apr  9 or 16.  No class Feb 13. Meets 10 times plus final exam.

Frank Diana

069-125

Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459

Required text: New Drug Development:  A Regulatory Overview, Mathieu, 7th ed, 2005, (ISBN: 1-882615-72-7)

5459. Drug Development (104)

8:30 am  – 5:00 pm Sundays

Note New Start Date: Feb 3, 17, Mar 2, 16, Apr 6. Make-up, if needed, Apr 13.   Meets 5 times.

Lionel Edwards

009-336

Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459

Required text:  Principles and Practices of Pharmaceutical Medicine,
Fletcher, Edwards, Fox, Stonier, 2^nd ed, (ISBN: 0470-093137).

5472. Pharmaceutical Marketing (101)

6:00 pm – 9:30 pm Mondays

Note new start date: Feb 4, 11, 25, Mar 3, 10, 17, 24, 31, Apr 7, 14, 21, 28, May 5. No class Feb 18. Class meets 10 times.  Extra dates scheduled.  Class will meet on consecutive weeks, unless Mr. Hisey has unexpected travel.   

Doug Hisey

092-077

Formerly Pharmaceutics 482.  Not open to students who have taken Pharmaceutics 482.

Required text:  Pharmaceutical Marketing: Principles, Environment and Practice, Smith, (ISBN:  0789015838).

5477. Good Manufacturing Practices (101)

6:00 pm – 9:30 pm Wednesdays

Jan 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26.  Make-up, if needed, Apr 2 or 9.  Meets 10 times plus final exam.

Richard Forsyth

092-086

Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

Required text:  Good Manufacturing Practices for Pharmaceuticals, 6^th ed., Nally (ISBN: 0-8493-3972-3).

5477. Good Manufacturing Practices (102)

8:30 am – 5:00 pm Saturdays

Jan 12, 26, Feb 9, 23, Mar 29.  No class March 8.  Make-up, if needed, April 12.

Frank Stevenson 

092-090

Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

Recommended text:  Good Manufacturing Practices for Pharmaceuticals, 6^th ed., Nally (ISBN: 0-8493-3972-3).

5494. Quality Audit (101)

8:30 am – 3:00 pm Sundays (1/2 hour lunch)

January 13, 27, February 10, 24, March 9, 30.  Make-up dates if needed, April 13 or 27. Class meets 6 times.

Jeffrey Werrmann

069-548

Formerly Pharmaceutics 494.  Not open to students who have taken Pharmaceutics 494

Prerequisite:  a good practices course (Pharmaceutics 5476, 5477, 5479, or 5536)

Required text: The ASQ Auditing Handbook, 3rd ed,, J.P. Russell.
Available from ASQ Quality Audit Division:  www.asq.org (ISBN # 9780873896665, ASQ Item # 1263).

5494. Quality Audit (102)

6:30 pm - 9:30 pm Mondays

Jan 28, Feb 4, 11, 18, 25, Mar 3, 10, 17, 24, 31, April 7, 14.  Make-ups, if needed, April 21 or 28.  Class meets 12 times plus final exam.

Teresa Preziosi

042-051

Formerly Pharmaceutics 494.  Not open to students who have taken Pharmaceutics 494.

Prerequisite:  a good practices course (Pharmaceutics 5476, 5477, 5479, or 5536)

Required text: The ASQ Auditing Handbook, 3^rd ed,,  J.P. Russell. Available from ASQ Quality Audit Division:  www.asq.org (ISBN # 9780873896665, ASQ Item # 1263).

5495. IND/NDA Submissions (101)

6:00 pm – 9:30 pm Thursdays

Jan 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27.  Make-up, if needed, Apr 3, 10 or 17.  Meets 10 times plus final exam.

Kevin Malobisky

069-828

Formerly Pharmaceutics 495.  Not open to students who have taken Pharmaceutics 495.

Prerequisites:  Drug Development (Pharmaceutics 5459) and/or Food and Drug Law I (Pharmaceutics 5592)

Required text:  New Drug Development:  A Regulatory Overview. Mathieu, 7^th ed, (ISBN:  1-882615-72-7).

5495. IND/NDA Submissions (102)

8:30 am – 5:00 pm Saturdays

Jan 12, 26, Feb 23 Mar 8, 29.  Class meets 5 times.  Make-up, Apr 12 or 26, if needed.

Randall Brenner

040-796

Formerly Pharmaceutics 495.  Not open to students who have taken Pharmaceutics 495.

Prerequisites:  Drug Development (Pharmaceutics 5459) and/or Food and Drug Law I (Pharmaceutics 5592)

Required text:  New Drug Development:  A Regulatory Overview. Mathieu, 7^th ed, (ISBN:  1-882615-72-7).

5495.  IND/NDA Submissions (110)

Held live at Frazer, PA.

Sheraton Great Valley, 707 E. Lancaster Ave, Frazer, PA   19355  610.524.5500

5:00 pm – 8:30 pm Mondays

Peter Smith

092-105

Formerly Pharmaceutics 495.  Not open to students who have taken Pharmaceutics 495.

Prerequisites:  Drug Development (Pharmaceutics 5459) and/or Food and Drug Law I (Pharmaceutics 5592).

Required text:  New Drug Development:  A Regulatory Overview. Mathieu, 7th ed, (ISBN:  1-882615-72-7).

5495.  IND/NDA Submissions (318)

Held live at Tarrytown, NY.

ALL CLASSES MEET AT THE WEST CHESTER MARRIOTT.

8:30 am – 3:00 pm (1/2 hr lunch) Sundays

NOTE NEW START DATE: Jan 27, Feb 10, 24, Mar 9, 30, Apr 13.  Make-up, if needed, Apr 27.  Meets 6 times.

John Schalago

092-842

Formerly Pharmaceutics 495.  Not open to students who have taken Pharmaceutics 495.

Prerequisites:  Drug Development (Pharmaceutics 5459) and/or Food and Drug Law I (Pharmaceutics 5592).

Required text:  New Drug Development:  A Regulatory Overview. Mathieu, 7th ed, (ISBN:  1-882615-72-7).

ALL CLASSES MEET AT THE WEST CHESTER MARRIOTT.

5499.  Drug Dosage Forms (101)

5:30 pm – 9:00 pm Tuesdays

Jan 22, 29, Feb 5, 19, 26, Mar 4, 11, 18, 25, Apr 1.  Make-up, if needed, Apr 8.  Meets 10 times plus final exam. No class Feb 12.

James Krupa

092-118

Formerly Pharmaceutics 499.  Not open to students who have taken Pharmaceutics 499.

Prerequisite:  strong scientific background in biology, chemistry, and mathematics is REQUIRED.

Required text: Pharmaceutical Dosage Forms & Drug Delivery Systems, 8^th ed., (ISBN:  0-781-746-124).

5501. Development of Sterile
Parenterals (101)

8:30 am – 3:00 pm (1/2 hr lunch)  Saturdays

Jan 26, Feb 9, Mar 8, 29, Apr 12, 26.  No class Feb 23.  Make-up, if needed, May 3 or 10.  Meets 6 times.

Dan Casaburi

069-166

Formerly:  Pharmaceutics 501.  Not open to students who have taken Pharmaceutics 501.

Prerequisite: strong science background consisting of a minimum of 2 years of general
chemistry, including organic chemistry and one analytical chemistry course. 
Students must fax their resume and registration to the
Assistant Dean at 267.468.8565 for permission to register.

No required text.

5515. Biologics/Biogenerics:  A Regulatory Overview (101)

6:00 pm – 9:30 pm Wednesdays

Jan 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 26, Apr 2.  Make-up, if needed, Apr 9. No class Mar 19.  Meets 10 times plus final exam.

Ray Bakhtiar

093-199

Required text:  Biologics Development-A Regulatory Overview, Mathieu, 3rd ed. (2004),
PAREXEL (ISBN: 1-882615-67-0).

Prerequisites:  Drug Development and Food and Drug Law I.
Students are expected to have a strong science background, including
familiarity with undergraduate chemistry & biology. An undergraduate
course in general biochemistry is also recommended.

Course description.

5517. Quantitative Methods in Benefit Risk Assessment (101)

5:30 pm – 9:00 pm Tuesdays

Paul E. Stang

093-180

Cancelled – will be offered in the summer or fall.

5533. Requirements for Product Labeling and Advertising (101)

8:30 am – 3:00 pm (1/2 hour lunch) Saturdays

Jan 19, Feb 2, 16, Mar 1, 15, Apr 5.  Make-ups, if needed Apr 19 or May 3.  Meets 6 times.

Barbara Fanelli/Steven Cipolla

092-136

Formerly Pharmaceutics 533.  Not open to students who have taken Pharmaceutics 533.

Prerequisite:  Pharmaceutics 592 (Food and Drug Law I) or permission of QA/RA Office
(Fax resume/registration to 267-468-8565).

No required text.

5536. Good Clinical Practices  (101)

6:00 pm – 9:00 pm Thursdays

Jan 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3, 10.   Make-up, if needed, Apr 17 or 24. Meets 12 times.    

Debra Weiss

092-147

Formerly Pharmaceutics 536.  Not open to students who have taken Pharmaceutics 536.

Required texts:  1) Good Clinical Practices:  A Question and Answer Reference Guide,
Mackintosh, Molly, and Mathieu, May 2006, (ISBN:  1-882615-78-6),
AND 2) 2007 CFR/ICH GCP Reference Guide. Order from:  www.barnettinternational.com.
Students who have the 2005/6 version are not required to order the new version.

5536. Good Clinical Practices (102)

8:30 am – 5:00 pm Saturdays

Note New Start Date:  Feb 2, 16, Mar 1, 15, Apr 5.   Make-up, if needed, Apr 12.   Meets 5 times.

Lionel Edwards

006-605

Formerly Pharmaceutics 536.  Not open to students who have taken Pharmaceutics 536.

Required text:  Principles and Practices of Pharmaceutical Medicine, Fletcher, Edwards, Fox, Stonier, 2^nd ed, (ISBN: 0470 093137). 

5537. Clinical Trial Management (101)

6:15 pm – 9:45 pm Wednesdays

Jan 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26.  Make-up, if needed, Apr 2 or 9 or 16.   Meets 10 times plus final exam.

John Zenno

003-569

Formerly Pharmaceutics 537.  Not open to students who have taken Pharmaceutics 537.

Prerequisite:  Good Clinical Practices (Pharmaceutics 5536).

Required text:  New Drug Approval Process, Guarino (Ed.), 4th ed.

5541. Pharmaceutical
Packaging & Regulation
(101)

8:30 am – 3:00 pm Sundays (1/2 hour lunch)

Jan 20, Feb 3, 17, March 16, and Apr 6.  There is a mandatory field trip tentatively scheduled for Friday, Feb 29, to a pharmaceutical packaging plant.  Please do not sign up for this class, if you cannot attend the field trip.  Class meets five times plus mandatory field trip.  Make-up dates, if needed, Apr 20 or May 4.

Michael Lusty

092-154

Formerly Pharmaceutics 540.  Not open to students who have taken Pharmaceutics 540

Required readings: FDA’s Container Closure Systems for Packaging Human Drugs and Biologics (from FDA website) http://www.fda.gov/cber/gdlns/cntanrq&a.pdf 

and Sub-part E:  Control of Components and Drug Product Containers and Closures of the cGMP Regulations (from FDA website) http://www.fda.gov/cder/dmpq/cgmpregs.htm

5575. Regulatory Sciences: 
Managing the Guidelines for Quality (101)

8:30 am – 5:00 pm Saturdays

Jan 19, Feb 2, Feb 16, Mar 1, 15, Apr 5, 19, May 3.  Class meets 5 times.  Please reserve all of the listed dates, since Dr. Schultz travels extensively.  He hopes to use the first 5 dates listed but may have to adjust his schedule.

Thomas Schultz

092-172

Formerly Pharmaceutics 580.  Not open to students who have taken Pharmaceutics 580

Prerequisite:  strong science background and permission of Dr. Schultz.  Please e-mail resume to: tschultz@prdus.jnj.com

No required text.

5591. Global Regulatory Affairs (101)

6:00 pm – 9:00 pm Mondays

Jan 28, Feb 4, 11, 18, 25, Mar 3, 10, 17, 24, 31, April 7, 14.  Make-ups, if needed, April 21 or 28.  Class meets 12 times plus final exam.

Daniel Larkins

092-189

Formerly Pharmaceutics 591.  Not open to students who have taken Pharmaceutics 591.

Prerequisite: Food and Drug Law I (Pharmaceutics 5592) or Drug Development (Pharmaceutics 5459) or permission of instructor (fax resume to QA/RA Office).

5592. Food and Drug Law I (101)

8:30 am – 3:00 pm Saturdays (1/2 hour lunch)

Feb 2, 16, Mar 1, 15, April 5, 19.  Make-up, if needed, May 3.  Meets 6 times.

Barry Berger  

040-965

Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

Required texts:  Food and Drug Law:  Cases and Material, 3^rd ed, Hutt, et al, Foundation Press, (ISBN # 978-1-58778-068-4) and FDLI Statutory Supplement (order Supplement from www.fdli.org.  Indicate that you are a full-time student).

5592. Food and Drug Law I (102)

6:00 pm – 9:00 pm Mondays

Jan 28, Feb 4, 11, 18, 25, Mar 3, 10, 17, 24, 31, Apr 7, 14.  Make-ups, if needed, April 21 or 28.  Class meets 12 times plus final exam.

Brian Bollwage

040-887

Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

Required text:  Food and Drug Law:  Cases and Materials, 3^rd ed, Hutt, et al, Foundation Press, (ISBN # 978-1-58778-068-4). This is a new edition (2007) of this text.  Please do not purchase earlier versions.

5592. Food and Drug Law I (103)

6:00 pm – 9:30 pm Wednesdays

Jan 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 26, Apr 2.  No class Mar 19. Make-up, if needed, Apr 9 or 16.  Meets 10 times plus final exam.

Craig Hammes

069-254

Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

Required texts:  Food and Drug Law:  Cases and Materials, 3^rd ed, Hutt, et al, Foundation Press, (ISBN # 978-1-58778-068-4). This is a new edition (2007) of this text.  Please do not purchase earlier versions, and FDLI Statutory Supplement (order Supplement from www.fdli.org.  Indicate that you are a full-time student).

5592. Food and Drug Law I (318)

Held live at Tarrytown, NY.

ALL CLASSES (except March 1) MEET AT THE WEST CHESTER MARRIOTT. March 1 class meets at the Marriott Courtyard.

8:30 am – 5:00 pm Saturdays

PLEASE NOTE NEW DATES:

Feb 16, Mar 1, 15, 29, Apr 12.  Make-up, if needed, Apr 19 or 26.  Meets 5 times.

Craig Hammes

092-683

Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

Required texts:  Food and Drug Law:  Cases and Materials, 3^rd ed, Hutt, et al, Foundation Press, (ISBN # 978-1-58778-068-4). This is a new edition (2007) of this text.  Please do not purchase earlier versions, and FDLI Statutory Supplement (order Supplement from www.fdli.org.  Indicate that you are a full-time student).

ALL CLASSES (except March 1) MEET AT THE WEST CHESTER MARRIOTT. March 1 class meets at the Marriott Courtyard.

5594. Regulation of Dietary Supplements, Botanicals, and Nutraceuticals (101)

5:30 pm – 9:00 pm Wednesdays

Jan 23, 30, Feb 6, 13, 20, Mar 5, 12, 19, 26, Apr 2.  Make-up, if needed, Apr 9 or 16.  No class Feb 27.  Meets 10 times plus final exam.

Alexa Smith

092-191

Pharmaceutics 594.  Not open to students who have taken Pharmaceutics 594

Required text:  Regulation of Functional Foods and Nutraceuticals: A Global Perspective, Hasler (Ed), First ed., 2005 (ISBN: 0-8138-1177-5).

5601. Industry Interactions with FDA & Health Authorities (101)

8:30 am - 3:00 pm Sundays (1/2 hour lunch)

January 13, 27, February 10, 24, March 9, 30.  Make-up dates if needed, April 13 or 27. Meets 6 times.

Alan Traettino

040-804

Formerly Pharmaceutics 601.  Not open to students who have taken Pharmaceutics 601.

Required text:  How to Work with the FDA, Wayne Pines.

Students should order this from FDLI (www.fdli.org), indicating they are

full-time students for the discount.

5612. Bioethics for Pharmaceutical Professionals (101)

8:30 am - 3:00 pm Sundays (1/2 hour lunch)

Feb 10, 24, Mar 9, 30, Apr 13 and 27.  Make-up if needed,

May 11.  Meets 6 times.

Sean Develin

041-654

Formerly Pharmaceutics 610.  Not open to students who have taken Pharmaceutics 610.

Required text:  Bioethics:  Beyond the Headlines, Jonsen (ISBN 0742545237) 

5618. Clinical Data Management (101)

6:00 pm – 9:30 pm Tuesdays

Jan  29, Feb 5, 12, 19, 26, Mar 4, 11, 18, 25, Apr 1.  Make-up, if needed, Apr 8, 15, 22 or 29. Meets 10 times plus final exam.

Patrick Genyn

069-247

Formerly Pharmaceutics 618.  Not open to students who have taken Pharmaceutics 618.

Prerequisites:  Pharmaceutics 5459 (Drug Development) and 5536 (Good Clinical Practices).

All required readings will be available from various websites.

5622. Unit Operations (101)

5:30 pm – 8:30 pm Tuesdays

David Lebo, et al

094-284

Cancelled – will be offered in the summer or fall.

8005. Biotechnology (101)

6:00 pm – 8:30 pm Thursdays

Jan 24, 31, Feb 7, 14, 21, 28, Mar 6, 20, 27, Apr 3, 10, 17, 24, May 1.  Meets 14 times plus final exam on May 8.  No class on Mar 13.  Make-up, May 15, if needed.

Tom Parry, PhD

069-530

This is a required course in the non-thesis MS program. Students may not receive credit for both Pharmaceutics 5475 (formerly 475) and Pharmaceutics 5471 (formerly 481).

Prerequisite: strong scientific background in biology, chemistry, and mathematics is REQUIRED.  There will be no review of basic science concepts; it will be assumed that students are familiar with them. QA/RA students must fax their resume and registration to 267.468.8565 to receive permission to take this course.

REQUIRED text:  Pharmaceutical Biotechnology: Fundamentals and Applications, Third Edition, Croomelin, Sindelar and Meibohm, eds, (ISBN-10: 1420044370 or ISBN-13: 978-1420044379).  Students may still use the second edition of this book, if they have it: Pharmaceutical Biotechnology, An Introduction for Pharmacists and Pharmaceutical Scientists,   Crommelin and Sindelar, Eds, 2^nd ed, (ISBN: 0-415-28501-1).

ALSO RECOMMENDED text: Biopharmaceuticals:  Biochemistry and Biotechnology, Wiley, 2^nd ed, (ISBN  -0-470-84327-6). Students must have biochemistry and molecular biology text books at their disposal.  In addition, relevant reading material will be assigned throughout the course.

SUMMER COURSE OFFERING

5611. Advanced Topics:  Regulation of Advertising & Promotions (101)

Offered live at AstraZeneca.  Videoconferenced to Temple U Fort Washington.

5:00 pm – 8:00 pm Wednesdays

April 2, 9, 16, 23, 30, May 7, 14, 21, 28, June 4, 11, 18.  Make-up dates, June 25 and July 2, if needed.

Preeti Pinto

Formerly Pharmaceutics 611.  Not open to students who have taken Pharmaceutics 611.

Prerequisites:  Drug Development (Pharmaceutics 5459) and Food and Drug Law I (Pharmaceutics 5592).

Required text: CFR - FDA Guidelines, CRF Title 21 Food & Drugs (Selected Laws, Regulations and Guidance on Drug Marketing, Advertising and Labeling).