|ANALYTICAL TESTING|

A Risk-Based Approach to Data Integrity

Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
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Is Your Calibration Really a Good Straight Line?

Statistical procedures give statistical answers not analytical judgment.
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|FORMULATION|

Mission Possible: Targeting Drugs to the Colon

Prodrugs and drug-delivery systems controlled by time, pH, and osmosis, are being used to prevent drug degradation in the stomach and small intestine and ensure drug release in the colon.
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|REGULATIONS/COMPLIANCE|

Breakthrough Drugs Raise Development and Production Challenges

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
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Unravelling the Complexity of EU’s ATMP Regulatory Framework

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.
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Compliance with US and EU Internal Audit Requirements

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.
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|OUTSOURCING|

CDMOs Cautiously Address Expansion

While all market signs are pointing up, memories of past setbacks may discourage CDMOs from expanding capacity.
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|TECHNICAL TOPICS|

Testing the Stability of Biologics

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.
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Getting Scientific About Cleaning Validation

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.
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|PACKAGING FORUM|

Ensuring Correct Tablet Count

Electronic pharmaceutical tablet counters meet demands for accuracy, flexibility, speed, compact size, easy cleanability, and quick changeover.
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|Webcasts|

Controlling the Physical Properties and Performance of Semi-solid Formulations Through Excipient Selection

Are you developing new topical products to meet specific design criteria? Are you seeking to replicate the performance of a reference product? In either case, you can achieve your goals by intelligently employing your toolkit of excipients and exploiting knowledge of how they work on a fundamental level. BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.
Sponsored by: BASF

Solubility Enhancement: Solutions using Predictive Analytics & Molecular Modeling

Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
Sponsored by: Patheon

The Importance of Data Integrity in a GXP Regulated Laboratory

With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Sponsored by: Mettler Toledo