Authors
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FDA Adopts Final Version of Q11 GuidanceFDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.
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Thermal Analysis with Pharmaceutical ApplicationsUse of thermal analysis techniques to characterize pharmaceutical products.
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HPAPIs And BioconjugatesThe market for HPAPIs is growing rapidly with the research industry's emphasis on oncology.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Controlled Crystallization During Freeze-DryingThe authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.
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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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Managing Information OverloadCompanies know they need regulatory information management, but they don't always know where to start and how to weave this capability across diverse technology applications.
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Addressing Segregation of a Low-Dosage Direct BlendThe authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.
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Technical Note: The Effect of Alcoholic Beverages on Sustained ReleaseThe authors evaluated the effect of alcoholic beverages on the release profiles of sustained-release dosage forms containing metformin and diclofenac.
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Should you implement modular cleanrooms?Modular cleanrooms are a flexible and adaptable solution that come on the back of a lorry and offer numerous benefits.
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Advanced renal models for toxicity screeningKidney transporter models are essential for identifying renal toxicity. Learn how immortalized primary renal tubule epithelial models stably expressing OAT1, OCT2 or OAT3 protein were tested for functionality.
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Taking a Closer Look into the Life-Science Funding Landscape in Europe and the United KingdomThe author looks at how life-science research has evolved in Europe and the United Kingdom, and discusses the current funding opportunities for SMEs.
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Industry Needs to Drive the Dialogue Regarding FDA’s Quality Metrics InitiativeGuest blog written by Walter Morris, Director of Publishing, Parenteral Drug Association, on behalf of the PDA Quality Metrics Task Force.
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Colored Brain Sparks FDA Warning LetterWarning Letters are a fact of life for the pharmaceutical industry and it can be difficult to avoid them.
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Is Pinterest the Risk-Free Social Channel for Pharma?I recently came across a blog post headlining Pinterest as the “safest place” for medical marketers to start with social media. All too aware that there are many Pharma marketers out there still a little shy of social, it was a must read.
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Solutol HS15 as a Novel ExcipientThe authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.
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Using Tocophersolan for Drug DeliveryTocophersolan or TPGS was developed 60 years ago as a water-soluble form of vitamin E. The author gives an overview of TPGS, including its interesting properties, examples found in the literature, and a brief summary of the regulatory status and marketed formulations.
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Mitigating Personnel RisksTraining cleanroom operators can be one of the most challenging aspects to maintaining cleanroom conditions. PTE speaks to Neal Wesley, technical director at SCM Pharma, to find out the best practices for training and ensuring continued compliance.
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Enhancing Dissolution of Poorly Soluble Drugs through Jet-MillingThe authors discuss a novel particle engineering technology based on mechano-chemical activation.
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In-Vivo Release Studies of Levamisole Phosphate and Ivermectin from an Isotropic Medium-Chain Mono and Diglyceride-Based Formulation Following Subcutaneous Injection in SheepFormulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
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In-Vivo Release Studies of Levamisole Phosphate and Ivermectin from an Isotropic Medium-Chain Mono and Diglyceride-Based Formulation Following Subcutaneous Injection in SheepFormulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
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In-Vivo Release Studies of Levamisole Phosphate and Ivermectin from an Isotropic Medium-Chain Mono and Diglyceride-Based Formulation Following Subcutaneous Injection in SheepFormulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
Latest:
In-Vivo Release Studies of Levamisole Phosphate and Ivermectin from an Isotropic Medium-Chain Mono and Diglyceride-Based Formulation Following Subcutaneous Injection in SheepFormulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
