American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

November 21, 2016

Newsletter Sponsor

White Paper on Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients
MilliporeSigma
The ICH Q3D Guideline for Elemental Impurities introduces risk assessment approaches and limits for maximum permitted daily exposure based on safety assessments for chronic exposure. However, it does not provide specific daily limits for major components of final drug products, bringing excipients in particular under scrutiny. Unlike APIs, excipients do not have established daily doses, leaving manufacturers with less information for calculating concentration limits. This white paper discusses an ICH Q3D-compliant control strategy model for risk assessment.

	Industry News

SOTAX and Waters Corporation Sign Co-Marketing and Re-Seller Agreement

PRN Pharmacal Acquires Assets of Veterinary Products Laboratories

FDA Grants Fast Track Designation for Development of E2609, Eisai's BACE Inhibitor for Early Alzheimer's Disease

Lyndra Scientists Develop Ultra Long-Acting Oral Drug Delivery Platform

Agios Announces Phase 1 Data from Dose Expansion Cohorts of AG-120 in Patients with IDH1 Mutant Positive Glioma and Chondrosarcoma

Merck Foundation Announces $10M Initiative to Improve Access to High-Quality Diabetes Care Underserved U.S. Communities

	Featured Articles

The Importance of Flexibility: Competitive Solutions In an Era of Innovation The Importance of Flexibility: Competitive Solutions In an Era of Innovation Nice insight is in conversation with uwe harbauer, senior vice president, pharma business unit, ... read more »

Distribution Channel Security in Ensuring Drug Supply and Safety Distribution Channel Security in Ensuring Drug Supply and Safety Congress passed the drug supply chain security Act in 2013. three years into its phased ... read more »

	Featured Announcements

Register now: Enabling custom solutions for downstream processing for future therapies - Webinar
Webinar
Thermo Fisher Scientific has developed innovative purification resins to provide purification ... read more »

	Featured Video

Webinar: Getting the Most out of Your Standard Curve
Webinar: Getting the Most out of Your Standard Curve
The first part of this webinar will outline controls that a laboratory should consider to assure consistency in standard curves and thereby increase ... read more »

Webinar: Compressed Gas Testing in Controlled Environments: Industry Trends & Best Practices
Webinar: Compressed Gas Testing in Controlled Environments: Industry Trends & Best Practices
Compressed gas testing is an important, but often overlooked component of any environmental monitoring program. read more »

	Featured Whitepaper

Science-Based Technology Selection And Formulation Development For Oral Bioavailability Enhancement
Science-Based Technology Selection And Formulation Development For Oral Bioavailability Enhancement
The increasing fraction of poorly water-soluble compounds in pharmaceutical discovery is leading to significant growth in the use of enabling technologies to improve oral drug absorption and ... read more »

Orbitrap Fusion MS for Glycan and Glycopeptide Analysis
Orbitrap Fusion MS for Glycan and Glycopeptide Analysis
Carbohydrate analysis, also known as glycosylation analysis, glycan analysis, or sometimes simply as sugar analysis, is of growing importance to sciences as diverse as pharmaceutical drug development,... read more »

	Events

IFPAC®-2017
North Bethesda, Maryland (Washington, D.C.) U.S.A. – 02/27/2017
Advanced Manufacturing Science… Emerging Technologies to Modernize Pharmaceutical/Biopharmaceutical Development and Manufacturing IFPAC is the ... event details »

DCAT Week ‘17
New York, NY – 03/20/2017
DCAT Week is the premier business development event for companies engaged in and supporting pharmaceutical development and manufacturing. Its unique ... event details »

This information is being brought to you because you are a subscriber to
American Pharmaceutical Review. To ensure delivery to your inbox,
please add newsletters@americanpharmaceuticalreview.com to your address book.

Manage your Subscription | Unsubscribe | Contact American Pharmaceutical Review

American Pharmaceutical Review
395 Oyster Point Blvd, Suite 300
South San Francisco, CA 94080 USA