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Pharmaceutical Technology-11-02-2017
Pharmaceutical Technology
Establishing an Effective Data Governance System
November 02, 2017
Features
41
11
Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
ODTs Dissolve Drug Administration Challenges
November 02, 2017
Cover Story
41
11
Ralph Gosden, head of product development at Catalent’s Swindon, United Kingdom site, explains the opportunities of orally disintegrating tablets as a patient-centric dosage form.
Reducing Medication Errors
November 02, 2017
Cover Story
41
11
Experts from Colorcon share insights on how manufacturers can play a role in minimizing the risk of medication errors by ensuring that the medicines they develop are well differentiated, especially between dosages of the same product.
Patient Centricity Takes Center Stage
November 02, 2017
Cover Story
41
11
Pharmaceutical companies are increasingly adopting patient-centric formulation development to ensure that drug products adequately meet the needs of end-users in all target patient populations.
Europe Leads the Way in Continuous Manufacturing
November 02, 2017
Regulatory Watch
41
11
The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.
Change Control for Standard Operating Procedures
November 02, 2017
Ask the Expert
41
11
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
CDMO Acquisitions Build Strategic Supplier Base
November 02, 2017
Outsourcing Outlook
41
11
Recent acquisitions are creating CDMOs with scale that rivals global bio/pharma.
A Revised Aseptic Risk Assessment and Mitigation Methodology
November 02, 2017
Features
41
11
The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.
FDA Overhauls Inspection Process and Field Operations
November 02, 2017
Regulatory Watch
41
11
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Awards Recognize Industry Contributions
November 02, 2017
From the Editor
41
11
Industry experts were honored for business, scientific, and social contributions.
Growing Demand for Taste-Masking Technologies
November 02, 2017
Features
41
11
Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.
Managing the Cost of Non-Compliance
November 02, 2017
Features
41
11
Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.
Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart
November 02, 2017
Peer-Reviewed Research
41
11
In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.
Custom-Design Process Vessel
November 02, 2017
Product Spotlight
41
11
The 300-gallon process vessel from Ross Charles can be customized according to specific user needs.
Feeder for Continuous Processing
November 02, 2017
Product Spotlight
41
11
The K3-PH-ML-D4-QT35 feeder from Coperion K-Tron is suited for multi-feeder clustering in a variety of continuous processes.
Air-Operated, Double-Diaphragm Pumps
November 02, 2017
Product Spotlight
41
11
Wilden's air-operated, double-diaphragm pumps feature bolted product containment, self-priming and dry-run capabilities, and are direct replacements for existing clamped and bolted pumps from the company.
Selecting the Appropriate Technology for Oral Bioavailability Enhancement
November 02, 2017
Features
41
11
Model-based formulation and technology selection methodologies facilitate rapid product development.
Comparing Endotoxin Detection Methods
November 02, 2017
Features
41
11
Inadequate endotoxin testing places patients at risk. Knowing the relative strengths and weaknesses of available test methods is crucial to maintaining quality and safety.
Pharmaceutical Technology, November 2017 Issue (PDF)
November 02, 2017
Issue PDF
41
11
Click the title above to open the Pharmaceutical Technology November 2017 issue in an interactive PDF format.
Temperature-Controlled Shipping Solution
November 01, 2017
Product Spotlight
41
11
The Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is compliant with good distribution practices and comes in three models.
Moving Toward Direct-to-Patient Models
November 01, 2017
Features
41
11
Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.