Authors
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Legal and Regulatory Perspectives on 3D Printing: Drug Compounding ApplicationsThis paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.
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Using Gas Headspace Analysis to Assess Glass and Nontraditional Vial-Closure IntegrityIncreased use of nested and ready-to-use primary packaging has resulted in a need for more validation data on container-closure integrity. This article describes efforts to develop these data for new and traditional containers and closures.
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Restructuring Method Transfer Through Global SitesMethod-transfer kits help simplify analytical method transfer for global site certifications.
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ePedigree: Using the Gift of Time WiselyThe year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees.
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Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) GuidelinesThis article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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Challenges of Expanding CAR-T Cell Therapy into Solid TumorsThe development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Controlled Release Redefined: The Strategic Use of Excipients in FormulationsWebinar Date/Time: Wed, Jun 12, 2024 11:00 AM EDT
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QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
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Getting Lab Data Closer to the Decision Point Keeps Product Release on TrackUsing one system for test execution and sample management, improving right-first-time, and allowing review by exception can deliver access to key lab data faster.
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Clinical And Cost Considerations Of Developing A BiosimilarBoth biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.
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Contamination Control for Cell and Gene Therapies Needs New AnalyticsAnalytical methods need a boost to ensure quality control for cell and gene therapies.
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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
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Talking Strategic Development with Simtra at DCATRay Guidotti, Chief Operating Officer at Simtra BioPharma Solutions, talks about the company's strategic development and how it supports customers with a focus on excellence.
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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QRM, Knowledge Management, and the Importance of ICH Q9(R1)This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment.
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Application of machine learning tools for predicting impact of punch cup depth on tablet cappingWe have proposed a comprehensive capping index parameter which is a ratio of compact anisotropic index to material anisotropic index. This study will help to design or select right tooling for successful tablet manufacturing.
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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
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EU Anti-Counterfeiting Legislation On Its WayIn order to combat the threat of counterfeits in Europe, the EU's current anti-counterfeiting directive is being amended.
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Revitalizing Quality Management Processes through DigitalizationEradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.
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Dielectric Spectroscopy: Choosing the Right ApproachThis tutorial paper is meant to aid in dielectric-sensor selection
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The Next Frontier in Pharmaceutical OutsourcingWhile companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.
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Coating and Taste Masking with ShellacThe authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.
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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
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Using Robotics in the Aseptic Manufacturing Facility of the FutureSeveral steps need be taken to achieve lights-out, fully automated operations.
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Specification Equivalence—A Practical ApproachIn this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
