DPS opened its laboratories in November 2016 with an initial focus on Formulation Development and Drug Product
The ICH Q3D document describes a number of scenarios by which the NDA/ANDA holder can demonstrate that the drug product
contains levels of El below the PDE and ensure that it will remain compliant throughout its life cycle.
THE FOOD AND DRUG ADMINISTRATION is currently accepting public comments on the agency's proposed plans to implement a law that will restrict compounding of human drug products
United States-based NanoSmart Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration for a second drug product
that uses the company's drug delivery platform.
US Food and Drug Administration (FDA) has confirmed receipt of the change of ownership letters formally transferring ownership of the 23 generic drug products
to IDT Australia Limited.
Maintaining the same goals as the first edition--"to describe, from concept to market approval, the development of high-quality, safe, and efficacious solid oral generic drug products
"--this second edition maintains its coverage of the scientific, regulatory, and legal issues important to moving generic drug products
from project initiation to marketing approval in the United States.
The selection and control of CCS used in drug product
administration and those used in the manufacturing process and storage are important parameters in pharmaceutical development and throughout the drug product
Compounding and filling: Drug substance to drug product
Intertek, a leading global Total Quality Assurance provider to industries worldwide, today announced that Interteks Technical Director for Inhalation Product Development will conduct a workshop on inhalation and nasal drug products
for scientists from the pharmaceutical industry, during the RDD Asia conference, Goa, India, November 8-11, 2016.
Hanns-Christian Mahler: Drug Product
Services complements Lonza's current drug substance offerings and enables us to provide one-stop-shop services to our customers.
com/research/601658/generic_drug_produ) has announced the addition of the "Generic Drug Product
Development: Specialty Dosage Forms" book to their offering.
Administration of a non-sterile drug product
intended to be sterile may result in serious and potentially life-threatening infections or death.