Research and Markets: Compatibility of Pharmaceutical Solutions and Contact Materials: Safety Assessments of Extractables and Leachables for Pharmaceutical Products

DUBLIN--(Business Wire)--
Research and Markets
(http://www.researchandmarkets.com/research/3a5890/compatibility_of_p) has
announced the addition of John Wiley and Sons Ltd's new report "Compatibility of
Pharmaceutical Solutions and Contact Materials: Safety Assessments of
Extractables and Leachables for Pharmaceutical Products" to their offering.

Important safety aspects of compatibility for therapeutic products and their
manufacturing systems, delivery devices, and containers

Compatibility of Pharmaceutical Products and Contact Materials helps
pharmaceutical, toxicology, analytical, and regulatory affairs professionals
assess the safety of leachable and extractable chemicals associated with drug
product packaging, manufacturing systems, and devices. The most comprehensive
resource available, its coverage includes the strategies, tactics, and
regulatory requirements for performing safety assessments, along with the means
for interpreting results.

Structured around a logical framework for an extractables and leachables safety
assessment and closely linked to the pharmaceutical product development process,
Compatibility of Pharmaceutical Products and Contact Materials directly
addresses the fundamental questions of "what activities need to be performed to
completely, efficiently, and effectively address the issue of product safety
from an extractables and leachables perspective?" and "when do the various
required activities need to be performed?"

Specifically, the chapters describe:

* Pertinent regulations and practical ways to meet guidelines
* Coordinating manufacturing, storage, and delivery systems development and
qualification with therapeutic product development
* Materials characterization and the materials screening process
* Component and/or system qualification (illustrated by several case studies)
* Performing validation/migration studies and interpreting and reporting the
results
* Creating a product registration dossier and putting it through regulatory
review
* Product maintenance (Change Control) from an extractables and leachables
perspective

Likely future developments in extractables and leachables assessment

Additionally, the book's appendix provides a database, including CAS registry
numbers, chemical formulas and molecular weights of extractable/leachable
substances that have been reported in the chemical literature.

Detailing the interconnected roles played by analytical chemistry, biological
science, toxicology, and regulatory science, Compatibility of Pharmaceutical
Products and Contact Materials supplies a much-needed, comprehensive resource to
all those in pharmaceutical product or medical device development.

Key Topics Covered:

PART A GENERAL CONCEPTS.

1. Introduction.

2. Nomenclature and General Concepts.

3. Extractables, Leachables, and the Product Life Cycle.

PART B MATERIAL CHARACTERIZATION.

4. Material Screening and Characterization.

PART C CONSTRUCT QUALIFICATION.

5. The Prototype Stage.

6. The Early Development Stage.

PART D CONSTRUCT VALIDATION.

7. Late Stage Product Development.

8. Submission.

9. Launch.

PART E PRODUCT MAINTENANCE.

10. Product Maintenance.

11. Retirement.

12. Focus on Emerging Concepts.

For more information visit
http://www.researchandmarkets.com/research/3a5890/compatibility_of_p.

Research and Markets
Laura Wood
Senior Manager
press@researchandmarkets.com
Fax from USA: 646-607-1907
Fax from rest of the world: +353-1-481-1716

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