| SUPPLEMENT |

APIs, Excipients, and Manufacturing

Be sure to check out this month’s APIs, Excipients, and Manufacturing special issue for articles on genotoxic impurities, nanomaterials, encapsulation, and more!
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|API SYNTHESIS & MANUFACTURING |

Stability Testing for Small-Molecule Clinical Trial Materials

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.
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| FORMULATION |

Overcoming Bioavailability ‘Roadblocks’ with LBDDS

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.
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| ANALYTICS |

The Fundamentals of Dissolution Testing

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
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Distribution of Data: The Central Limit Theorem

Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution.
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| MANUFACTURING |

New Technologies for Fill/Finish Streamline Operations

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.
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| QUALITY/REGULATIONS |

Lessons from FDA 483s and cGMP Inspection Data

Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
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| PEER-REVIEWED RESEARCH |

Optimizing Manufacturing Based on the Storage Stability of Pegylated Products

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
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| FROM THE EDITOR |

Image Repair Must Get to the Root Cause

Climbing out of a reputation hole starts with adopting a quality culture.
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| US REGULATORY WATCH |

Data Integrity Violations Draw Strong FDA Rebukes

Falsified documents and manipulated test results prompt warnings and investigations.
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| ASK THE EXPERT |

ALCOA+ and Data Integrity

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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