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American Pharmaceutical News In Review
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October 12, 2020
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  Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies. Spending more time on study design and development upfront will save valuable resources in the long run.

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» Industry News
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  Bristol Myers Squibb to Acquire MyoKardia
Bristol Myers Squibb and MyoKardia announced a definitive merger agreement under which Bristol Myers... read more »
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  BioNTech, Pfizer Initiate Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate
Pfizer and BioNTech announced the initiation of a rolling submission to the EMA for BNT162b2, the ... read more »
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  OWP Announces IND Approval for Quetiapine Fumarate Liquid Oral Suspension Formulation
OWP has received approval for IND application from the FDA for the first-ever liquid formulation of ... read more »
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  Catalyst Announces Issuance of U.S. Patent for Firdapse
Catalyst announced the USPTO has issued a new patent for Firdapse, expiring April 7, 2034. read more »
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  Biosense Webster Receives FDA Approval for Thermocool Smarttouch SF Ablation Catheter
Johnson & Johnson Medical Devices announced the FDA approval of Biosense Websters Thermocool ... read more »
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  Kodiak Sciences Treats First Patients in Three Phase 3 Studies of KSI-301
Kodiak announced the first patients have been treated in three pivotal Phase 3 studies of KSI-301, ... read more »

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» Featured Articles
Process Analytical Technology and Real-Time TOC Testing of Pharmaceutical Grade Water Systems
Real-time total organic carbon (TOC) and conductivity testing enables optimized monitoring programs for pharmaceutical grade water systems. With ... read more »
2020 Purified Water Monitoring Survey
American Pharmaceutical Review recently conducted a survey of our readers to determine their thoughts regarding pure water monitoring. Specifically, ... read more »
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» Featured Announcements
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  Webinar Tomorrow - An integrated solution for Sf9 Host Cell DNA & Baculovirus DNA detection
Development and Validation of a Duplex qPCR assay for the Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
Join Dr. Kara Norman from Thermo Fisher Scientific on October 13, 2020 as we discuss the development... read more »
» Infographic
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  Top 5 Secrets to a Successful Cleaning Validation Program
Here are five ways to ensure a successful and compliant cleaning validation program. read more »
» Featured Video
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  Watch Video: Alconox APR Interview Video with Michael Moussourakis
Alconox APR Interview Video with Michael Moussourakis watch »
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  Interphex Live 2020: Using Contact Lenses as a Drug Delivery System
Interphex Live 2020: Using Contact Lenses as a Drug Delivery System watch »

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» Featured Products
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  Accucore Solid Core Columns
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  Impact of Container Closure on Drug Safety
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» Featured Whitepaper
R&D to Product: How to reduce costly scale-up problems
When scaling a new drug formuation. read more »
The Influence of Matrix Plasticity on Lubricant Effects
Tablet hardness is essential when formulating a solid dosage form. Certain combinations of commonly used excipients may lead to softer tablets. This study outlines how to avoid those pitfalls and learn which excipients will enhance compaction. read more »

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| Events
EVENT
  SMi’s 3rd Annual Pharmaceutical Microbiology East Coast
Virtual –  10/28/2020
Exploring the current approaches towards improved contamination control The pharmaceutical microbiology industry has seen many changes during the ...
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EVENT
  Pre-Filled Syringes and Injectable Drug Devices 2021
London, UK –  01/13/2021
Device design, regulatory and strategic pathways for parenteral drug delivery   SMi is proud to present the 13th Annual Pre-Filled Syringes ...
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