FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
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
Author(s)Pharmaceutical Technology Editors
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
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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.
Articles in this issue
about 11 years ago
CDMOs Move Slowly with Expansion Plansabout 11 years ago
Accelerating Continuous API Synthesisabout 11 years ago
BioOutsource Opens New Facility in Glasgowabout 11 years ago
Silicone Rubber Pieces Spur Recall of Teva Productabout 11 years ago
Baxter Recalls IV Solution for Container and Particulate Issuesabout 11 years ago
Indian API Manufacturer Cited for Recordkeeping Failuresabout 11 years ago
Xcelience Makes Investment in Powdersizeover 11 years ago
FDA Issues Quality Metrics Draft Guidance Document for Commentover 11 years ago
EMA Issues Guideline on Fast Tracking Drugs for Unmet NeedsAdvertisement
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FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
Sanjay Konagurthu, PhD, senior director of Science and Innovation at Thermo Fisher Scientific, explains what teams need to do to ensure the usefulness of AI and what strides have been made with AI in regulatory submissions.
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.
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