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Pharmaceutical Book from C.H.I.P.S.

Compatibility of Pharmaceutical Products and Contact Materials
Safety Considerations Associated with Extractables and Leachables
by Dennis Jenke

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.

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?"

Contents

General Concepts

  1. Nomenclature and General Concepts
  2. Extractables, Leachables, and the Product Life Cycle
Material Characterization

  1. Material Screening and Characterization
Construct Qualification

  1. The Prototype Stage
  2. The Early Development Stage
Construct Validation

  1. Late Stage Product Development
  2. Submission
  3. Lauch
Product Maintenance

  1. Product Maintenance
  2. Retirement
  3. Focus on Emerging Concepts

Index

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Compatibility of Pharmaceutical Products and Contact Materials
Safety Considerations Associated with Extractables and Leachables
by Dennis Jenke

2009 • 379 pages • $116.00 + shipping
Texas residents please add 6.75 % sales tax

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