| API SYNTHESIS AND MANUFACTURING |

FDA Ramped Up Approval Rate in 2017

FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.
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| FORMULATION |

Tackling the Opioid Crisis with Abuse-Deterrent Formulations

Abuse-deterrent opioid formulations generally fall into two categories: the first is based on a physiochemical abuse-deterrent approach and the second combines the opioid with an antagonist.
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| FLUID HANDLING |

Selecting and Installing Peristaltic Pump Tubing

Proper selection and installation optimizes fluid system performance.
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| INTERNET OF THINGS |

Pharma Equipment Gets Smart

The Industrial Internet of Things can be used in the bio/pharmaceutical industry to monitor equipment health, optimize processes, and enable modular facilities.
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| PEER-REVIEWED RESEARCH |

Removing Subjectivity from the Assessment of Critical Process Parameters and Their Impact

A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster and less subjective critical process parameter quantification, visualization, and documentation.
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| QUALITY |

Process Validation in Biologics Development

Process validation is an extension of biologics development processes.
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| ELEMENTAL IMPURITIES |

Determination of Dermal PDE for Pharmaceutical Products

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.
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| PACKAGING |

Boosting Functionality of Container Closures

Closures that protect solid-dosage drugs and the capping equipment that applies them have new product-protecting features.
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| PHAMACEUTICAL SERIALIZATION |

Pharma Serialization Nears a Tipping Point

Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they've learned from serialization to improve overall efficiency.
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| ASK THE EXPERT |

Meeting Data Integrity Requirements

Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
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| FROM THE EDITOR |

New Year, New Questions

Bio/pharma professionals manage expectations amid industry uncertainty.
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