American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

March 24, 2021

Newsletter Sponsor

Challenges and Best Practices for Extractables and Leachables in Ophthalmic Drug Products

Prior to 2018, ophthalmic drug products (ODPs) and parenteral drug products (PDPs) were both treated the same way when undergoing Extractables and Leachables (E&L) testing. However, ODPs differ significantly from PDPs in terms of route of administration, toxicological end-points and the nature of their container closure system.

	Industry News

NIH Releases Statement on AstraZeneca Vaccine
The DSMB notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by ... read more »

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
The FDA granted marketing authorization of the BioFire Respiratory Panel 2.1. read more »

ARISE-3 Dry Eye Trial Does Not Meet Primary Outcome Measures
RegeneRx announced that the ARISE-3 Phase 3 clinical trial evaluating RGN-259 eyedrops for the ... read more »

Sagimet Biosciences Receives Fast Track Designation from FDA for NASH Treatment
Sagimet Biosciences announced the FDA has granted Fast Track designation to TVB-2640 for the ... read more »

AbbVie Announces Extension of Review for sNDA of Upadacitinib for Active Psoriatic Arthritis
AbbVie announced the FDA has extended the review period for the sNDA for upadacitinib in the ... read more »

Precigen Receives Orphan Drug Designation for PRGN-AdenoVerse™ Immunotherapy for Respiratory Papillomatosis
Precigen announced the FDA has granted ODD for PRGN-2012, an investigational off-the-shelf ... read more »

	QC Corner

Horseshoe Crab Sustainability Project
In this poster video, Brett Hoffmeister, the LAL Production Manager from the Associates of Cape Cod ... read more »

The Effect of Surge Vessels on the Residence Time Distribution of Drug Substance Continuous Processes
While most of the published work on the impact of residence time distribution (RTD) to ... read more »

	Infographic

Measuring Total Organic Carbon (TOC) Continuously in Real-Time
Total Organic Carbon (TOC) control is essential in the production of high purity pharmaceutical water. Whether you are upgrading your current system ... read more »

	Featured Articles

Poor Solubility – Where Do We Stand 25 Years after the ‘Rule of Five’? The ‘Rule of Five’ (Ro5) is clearly aimed at medicinal chemists. However, in the past 25 years we have seen an increase in the number of poorly water-... read more »

IDMP – Transforming Medicine Management with Global Data Standards The coronavirus response highlighted the need for global data standards in medicine, giving renewed impetus to work on IDMP (Identification of ... read more »

	Featured Video

On-Demand Webinar: Performance Enhancement Strategies for Low Solubility APIs – Do More with Less
In this webinar you'll learn about the interplay between formulation and process aspects to achieve optimal bioavailability for amorphous dispersions,... watch »

On-Demand Webinar: Reactive-to-Proactive Process Monitoring in Pharmaceutical Waters
In this webinar you'll learn about real-time TOC, Conductivity/Resistivity, temperature and microbial process information provides better transparency... watch »

	Featured Products

FT 2 Tablet Friability Tester
read more »

HyClone CCM5 Cell Culture Media
read more »

	Featured Whitepaper

eBook: Slope Spectroscopy Method
The SoloVPE System is an innovative instrument for the UV-VIS-NIR spectroscopy. read more »

Hard Choices: Decontamination of plastic surfaces with UVC light
The germicidal effect of ultraviolet-C (UVC) light has proven effective as a no-touch, fast, and residue-free solution against microorganisms and biomolecules. UVC treatment conditions are highly ... read more »

	Events

Oligonucleotide Therapeutics and Delivery Conference
London, UK – 09/22/2021
On the way to maximising the potential of oligo-based medicine Oligonucleotide therapeutics - the emerging medicine class - are harnessing the ... event details »

Wearable Injectors and Connected Devices Conference 2021
London, United Kingdom & Online – 10/18/2021
Innovations in on-body devices and connectivity to aid drug delivery and patient experience The global wearable devices market size is expected to... 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
164 Townsend St. Unit 2
San Francisco, CA 94107 USA