Oral and Inhalatory Drug Delivery Systems Assessing

CfPA
Online Training Course
Oral and Inhalatory Drug Delivery Systems
Assessing Complex Dosage Forms Performance
Day: Tuesday, June 9, 2015 Time: 10:00 a.m.–11:30 a.m. (ET)
Location: Your Computer Offering # 1506-208 Priority Code: 520
(Available On-Demand starting 6/10/15)
WHO SHOULD ATTEND
The online course will be of value to professionals working in research and product development in pharmaceutical, biotech and related sectors,
who want to learn how to characterize and understand complex dosage forms performance, and to identify and address key factors affecting
such performance. The course is addressed to:
• Pharmaceutical R&D Scientists and Managers
• Business Development and Intellectual Property Managers
• Biotechnologists
• Regulatory Affairs Personnel
• Technology Transfer Managers
• Investors in Biomedical, Pharma and New Technologies
Scientists and Managers from academia, start-ups, drug discovery and early drug development companies will benefit from the course.
Technical and business staffs who serve in CROs and CMOs environment using a broad spectrum of delivery technologies will also derive
significant benefit.
LEARNING OBJECTIVES
Upon completion of this training, you will be able to:
• Explain the fundamental aspects of drug delivery
• List the critical factors impacting performance of a complex delivery system
• Explain and select the technologies necessary to best assess drug product performance in vitro and in vivo
• Address early-on physico-chemical and biological factors favoring optimal dosage form performance
• Define a realistic achievable Target Product Profile (TPP) based on delivery system performance in vitro and in vivo
COURSE DESCRIPTION
This 90- minute accredited online training will provide an understanding of how to address and solve the critical aspects affecting complex
drug product performance. Emphasis will be put on characterization of in vitro and in vivo behavior of delivery systems, based on the use of
state-of-the-art-technologies. Case examples, specifically taken from industrial experience, will be briefly described to emphasize the practical
advantages of early characterization of dosage form performance.
Review of Learning Objectives
Module 1: Define drug product performance
• Defining the “performance” of a drug
delivery system: efficacy, safety,
bioequivalence, biosuperiority
• DP performance and “realistic “ TPP
• Biopharmaceutical , Developability and
Drug Disposition Classification Systems
(BCS; DCS; BDDCS) as tools to “define”
product performance
• Aspects specific to oral and inhalatory
delivery
Module 2: In vitro tools to predict product
performance
• Physico-chemical tools
– Solid state properties affecting drug
product performance. Bulk and surface
characterizations.
– Solubility and supersaturation. Drug
Dissolution Rate. Choice of biorelevant
media.
– USP/EuPh dissolution methods selection.
– Tools to predict system performance for
different delivery routes
• Biological tools
– Understanding biological barriers
complexity in gastrointestinal and
respiratory tract
– Cell and tissue models to characterize
drug product performance
Module 3: in vivo tools to understand
system performance
• Assessing “performance” in vivo:
Pharmacokinetics, Pharmacodynamic,
Therapeutic efficacy
• Overview of imaging technologies to see
and understand complex dosage form
behavior.
• Gamma scintigraphy. Labelling of complex
dosage forms representative of cGMP lots.
• Quantitative correlations of dosage form
imaging with PK/PD data: assessment of
performance in vivo.
Question and Answer Session
For more information see reverse sidea
190 State Highway 18, Suite 203, East Brunswick NJ 08816
Phone 732-238-1600 • Fax 732-238-9113
www.cfpa.com
COURSE DIRECTOR
Dr. Pierandrea Esposito
Dr. Pierandrea Esposito is Cofounder and Associate Director at SiTec PharmaBio, a company focused on the development of innovative
technologies for drug delivery, based on dense-CO2 processing. He has 25 years experience in pharmaceutical and biotech industry, and held
several director or management positions at Esteve, SiTec Consulting, Critical Pharmaceuticals Ltd, Serono, and Vectopharma. Dr. Esposito
has experience in pharmaceutical development, from late discovery-feasibility stages to clinical phases and preregistration activities, developing
drug products based on delivery systems, advanced formulations, and conjugation technologies. His scientific interests focus in micro and
nanoparticulate systems, biomolecules delivery, in drug solubilization/absorption of small molecules for oral and transmucosal routes, in physical
pharmacy. He is also interested in the application of imaging techniques to drug delivery.
Dr. Esposito graduated in Pharmaceutical Chemistry and Technology, University of Trieste, (Italy). He has been visiting scientist at College
of Pharmacy, University of Kentucky (USA), attached professor at University of Sao Paulo (Brasil), and at University Piemonte Orientale
“A.Avogadro”, Novara (Italy). He coauthored 22 publications (research articles, reviews, book chapters), and 45 abstracts; he is a coinventor in
16 patents, and a member of Scientific Editorial Boards of several international journals.
TUITION AND REGISTRATION
TUITION *– Single Rate: U.S. $295.00 per person
Group Rate: U.S. $245.00 per person**
Register at www.cfpa.com. Enter Course Offering #1506-208 into Search. To register use Priority Code: 520.
For Questions and Information call Customer Service at 732-613-4500.
Please Note: M
ultiple participants are not authorized to share access provided to a single registrant, a single dedicated seat license must be purchased for each individual. CfPA
reserves the right to cancel access or collect the group rate payment if this requirement has been violated. Only registered participants will receive accreditation.
System Requirements: PC-based attendees: Windows(R) 7, Vista, XP or 2003 Server/Macintosh(R)-based attendees: Mac OS(R) X 10.4.11 (Tiger(R)) or newer
ACCREDITATIONS
The Center for Professional Advancement has been approved as an Authorized Provider by the International Association for Continuing Education
and Training (IACET), 1760 Old Meadow Road, Suite 500 McLean, VA 22102. In obtaining this approval, The Center for Professional Advancement
has demonstrated that it complies with the ANSI/IACET Standards which are widely recognized as standards of good practice internationally. The
Center for Professional Advancement is therefore authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET Standards.
CEU will be awarded for participation in The Center for Professional Advancement’s courses at the rate of .1 CEU per contact hour. CEU will be
awarded only upon successful completion of the entire course and 70% accuracy in the required Learners’ Assessment.
WHO WE ARE
The Center for Professional Advancement (CfPA) is the largest accredited technical training organization in the world with a curriculum of
approximately four hundred and fifty short courses in 15 industries including Pharmaceutical, Biotechnology, Medical Device, Chemical,
Cosmetics, Food and more.
Since our founding in 1967, we have successfully trained nearly a half million people worldwide in topics ranging from basic and introductory
concepts to new advances and cutting-edge technology, and current U.S. and European regulations. CfPA courses are offered in a variety of
formats – Public offering, Client Site and Online – to fit you or your company’s training needs.
For more information visit our website at www.cfpa.com
COURSES OF INTEREST
•G
ood Clinical Practices (GCP)
course ID# 107
• INDs/NDAs/CTDs
course ID# 448
• Introduction to Drug Delivery Technology
course ID# 2084
•A
erosol Technology
course ID# 669
• Non-Clinical Drug Safety Evaluation and Drug Development
course ID# 1153
• Pharmaceutical Process Development
course ID# 1358
TERMS AND CONDITIONS
*Payment: Tuition payable in US funds net of all charges. Payment is due at time of registration in the form of a credit card. Please contact CfPA’s Customer Service for other payment options.
**Group Rate: The Group Rate is for two or more enrollments, up to five registering from the same company at the same time. For groups of six or more, please contact Customer Service for group pricing.
Cancellations/No Show: “Live”- Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one
year from date of issuance. No credit will be issued for no-shows and/or cancellations less than two worki­­ng days prior to the course. : “On-Demand”- No refund or credit will be issued for
no-shows and/or cancellations of on-demand training courses. CfPA is not responsible for any outside related costs incurred by registrant’s cancellation.
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