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News|Articles|July 16, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

  • PTSM: Pharmaceutical Technology Sourcing and Management-08-05-2015
  • Volume 11
  • Issue 8

EMA Releases API Bioequivalence Studies Guidance

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

 

The European Medicines Agency (EMA) opened up for consultation product-specific guidance documents on bioequivalence studies for the active substances asenapine, prasugrel, sitagliptin, and zonisamide.  The release of the guidance documents follows finalization of bioequivalence guidance on 16 active substances in 2014 and 2015.

The guidance documents, which can be found on EMA’s website, are available for comment until Nov. 1, 2015.

Source: EMA

Articles in this issue

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CDMOs Move Slowly with Expansion Plans

almost 11 years ago

Accelerating Continuous API Synthesis

almost 11 years ago

BioOutsource Opens New Facility in Glasgow

almost 11 years ago

Needle in the Haystack, or Rembrandt in the Attic? Drug Repurposing's New Strategy

almost 11 years ago

Silicone Rubber Pieces Spur Recall of Teva Product

almost 11 years ago

Baxter Recalls IV Solution for Container and Particulate Issues

almost 11 years ago

Indian API Manufacturer Cited for Recordkeeping Failures

almost 11 years ago

Xcelience Makes Investment in Powdersize

almost 11 years ago

FDA Issues Quality Metrics Draft Guidance Document for Comment

almost 11 years ago

EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs

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