Authors
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I Saw the Future of Global Pharmaceutical Production in IndiaGuest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.
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Quality Quartets in Risk-Based Qualification:Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
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Is “right first time, every time” a pipedream for metabolite identification by LC-MS?The dream state If we lived in an ideal world, it would be possible to unambiguously identify metabolites using a single analytical experiment. This analytical technique would need to be efficient and easily generate the information needed from a routine assay that is also robust, enabling confident decision-making during drug discovery. At SCIEX, we believe that metabolite identification using the ZenoTOF 7600 system gets close to this dream state.
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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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Master File Submission of StructuresThe SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
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Dielectric Spectroscopy: Choosing the Right ApproachThis tutorial paper is meant to aid in dielectric-sensor selection
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Interview with Hayley Crowe, Executive VP & GM at Ecolab Global Life SciencesHayley Crowe, Executive VP & GM at Ecolab Global Life Sciences, talks about the company's services and how they relate to trends in bioprocessing and purification.
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Intervention Risk Evaluation and Management in Aseptic Manufacturing–Part IIIREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.
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Sterile Production According To The New EU GMP Annex 1: A Focus On CappingThe recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.
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Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulationsTesting the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.
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Best Practices for Pharma Manufacturing Quality TeamsAutomated systems help detect and resolve quality issues.
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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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Reducing Uncertainty of an Analytical Method through Efficient Use of ReplicationA well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
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ACS-Grade Reagents’ Database LaunchedThe complete online database of ACS Reagent Chemicals is now available.
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An All-Round Excipient For Direct CompressionUsing new co-processing technologies, the authors show that it is possible to formulate an 'all-round' excipient.
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Accelerating Time-to-Insight Throughout the BioPharma LifecycleInnovation is driven through a strong digital backbone.
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Table Testing TechniquesThe rising popularity of fast dissolving, immediate-release dosage forms can be attributed to their convenience and ease of administration.
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How Integrated Project Delivery Enables Speed: A Phase-By-Phase GuideBy eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
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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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Build CMO Relationships with Effective Management PracticesContract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.
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Variables Affecting Reconstitution Time of Dry Powder for InjectionThe authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.
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Evaluating Okra Gum in a Floating Tablet Formulation as a Novel Drug Delivery SystemThe potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.
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The Pros And Cons Of Single-Use SystemsThe willingness of the industry to use single-use bioreactors is currently influenced by the criticality of the step, the value of the product and the time for product development and production.
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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Evaluation of Procipient ®(Dimethyl Sulfoxide USP, PhEur ) in Topical Dosage Form FormulationsProcipient ® (Dimethyl Sulfoxide USP, PhEur ) is the only compendial DMSO specifically for pharmaceutical use. Procipient is supported with the proper documentation required by pharmaceutical regulatory authorities.
