Authors
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Effective Technology Transfer and Validation Strategies with CMOsThe success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \
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Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase ColumnsThis paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase ColumnsThis paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase ColumnsThis paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase ColumnsThis paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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Cleaning Limits—Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part IIConventional limit-setting techniques are not health-based and can make risk assessment more difficult.
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Debating the Role of RABS and Isolators in Aseptic ManufacturingWhile isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.
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Planning for Successful Technology TransferThe author reviews some of the key considerations when selecting a vendor and crucial parameters that must be defined in the tech-transfer process to ensure the greatest chance of success.
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In-Process Particle CharacterisationIn wet granulation, many companies used to rely on empirical data and quality control, but processes and technologies have improved in a variety of ways in recent years.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Commonly Cited Deficiencies for Topical Dermatologic Drug Products in ANDAsThe authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.
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Commonly Cited Deficiencies for Topical Dermatologic Drug Products in ANDAsThe authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.
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Ophthalmic Drug Packaging: Safety Risks and Patient Acceptability IssuesThe authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Ophthalmic Drug Packaging: Safety Risks and Patient Acceptability IssuesThe authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
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The BioRegion of Catalonia—A Unique Life-Sciences Hub in EuropeBarcelona is set to host two well-known pharmaceutical events in the upcoming calendar year: CPhI (October 4–6, 2016) and BIO Europe Spring (March 20–22, 2017). The city is the heart of the BioRegion of Catalonia, believed to be the most dynamic bioregion in Spain and one of the most active in Europe.
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Maintaining Hygienic Diaphragm ValvesA process-specific preventative maintenance program improves productivity and reliability.
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De-activating the Ticking Bomb of Brain Diseases with NanomedicinesNanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.
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Looking for a Root Cause of Parenteral ContaminantsMultiple inspection techniques facilitate the identification of particulate matter in vials as part of root-cause investigations and safety evaluations.
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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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A Novel Solid-Dose InjectionA study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.
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A Novel Solid-Dose InjectionA study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.
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A Novel Solid-Dose InjectionA study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.
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A Novel Solid-Dose InjectionA study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.
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Advances in the Regulated Pharmaceutical Use of Dimethyl Sulfoxide USP, Ph.Eur.The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.
