Authors
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Advancing Spray-Dried Dispersion Formulation DevelopmentIn-vitro and in-silico tools can help predict in-vivo outcomes for low-solubility drugs formulated as spray-dried dispersions.
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Drug Shortages and Complying with FDA’s 21 CFR 211.110 GuidanceSusan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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Pharmaceutical Knowledge Management: Experiences in Drug Development and ManufacturingKnowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years
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A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing ProcessResearchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.
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Implementing Data Integrity Compliance in a GLP Test FacilityConsider how to apply ALCOA+ to a building management system in non-clinical laboratories.
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Improved Formulations to Enable Stable Delivery of BiologicsHow dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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Integrated Approach Facilitates Inhalation Drug DevelopmentThe choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.
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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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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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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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How to Meet Regulatory Challenges in the New YearWith 2007 projects wrapped up, or so we hope, forward-looking companies need to take their next step.
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Unpacking the Science Behind Data IntegrityWebinar Date/Time: Thursday February 24, 2023 at 11am EST | 10am CST | 8am PST
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Power Ultrasound and the Production of Mesoscopic Particles and Aqueous DispersionsThe authors discuss advanced sonocrystallization particle-engineering techniques for manufacturing mesoscopic particles.
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Servier: patience and passionYou don't have to spend any time in the company of its chairman to see that there is no other Big Pharma company like Servier.
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Formulation effects on the thermomechanical properties and permeability of free films and coating filmsUnderstanding a formulation's variable effects on its properties, especially film permeability, is key to designing a robust formulation and reducing variation of a finished product.
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Packing-Line Improvement Based on a Fault-Tree Analysis ApproachThis article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.
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Jake Sorofman Q&AQ: You have many years of experience in marketing and business development. What are the most significant changes you have observed in this time?
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The extrusion and spheronization of chitosanChitosan is of pharmaceutical interest because of its positive attributes with respect to toxicity, biocompatibility and bioavailability.
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The new biopharmaceutical blueprintAs a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.
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Improved Mass Determination of Poly(ethylene glycols) by Electrospray Ion-Mobility Time-of-Flight Mass Spectrometry Coupled with Ion–Molecule ReactionsThe authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.
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The BRIC Countries: Opportunities for Regulated Market PlayersThe author outlines the opportunities and challenges for manufacturers aiming to enter the BRIC-country markets.
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A stability-indicating HPLC procedure for determination of diltiazem hydrochloride in extemporaneously compounded oral liquidsThe stability of drugs in solid forms such as powders, tablets and capsules is usually determined very thoroughly by the drug's manufacturer. Based on stability study data, the shelf-life of a drug substance or a drug product is assigned. In addition to dispensing solid dosage forms to patients, pharmacists are frequently asked to compound oral liquid preparations for which the shelf-life or beyond-use date are assigned based on the pharmacist's best judgment - often without the benefit of stability data.
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Improving the Integrity Test Assurance of Multiround Housings AssessmentsThe authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.
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Creating PVA copolymer capsulesWhen drugs are encapsulated, electrification (the electrostatic charge of the capsule) may sometimes cause problems, such as capsule adhesion during transportation or dispersion of the capsule content in the filling process.
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Formulation effects on the thermomechanical properties and permeability of free films and coating filmsUnderstanding a formulation's variable effects on its properties, especially film permeability, is key to designing a robust formulation and reducing variation of a finished product.
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Solid Dispersions by Hot-Melt ExtrusionThe advantages and disadvantages of hot-melt extrusion in solid dispersion formulations.
