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| Sustainable Packaging Resources
| | | By
Hallie Forcinio
| | | When it comes to designing and sourcing sustainable packaging, there are no simple answers. Sustainable packaging depends on a complex interaction of environmental, social, and economic considerations, which are influenced by geography and other factors such as renewability, compostability, biodegradability, weight, and performance.
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| Strategy for the Prediction and Selection of Drug Substance Salt Forms
| | | By
Harry G. Brittain, PhD
| | | Through consideration of the ionic equilibria of acids and bases, one may readily calculate the formation constant of a salt species solely on the basis of knowledge of the pKA value of the acid and the pKB value of the base.
| | | Materials of Construction Based on Recovery Data for Cleaning Validation
| | | By
Richard J. Forsyth
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Julia C. O'Neill
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Jeffrey L. Hartman
| | | The material of construction is a factor in the recovery of residue in cleaning validation. An analysis of existing recovery data showed that recovery factors for drug products on various materials of construction may be categorized into several groupings.
| | | Functionality-Related Characteristics of Excipients
| | | By
Henning G. Kristensen
| | | Amidst debate, the European Pharmacopoeia Commission is working to include physical or "functionality-related characteristics" of exipient materials in its monographs.
| | | Acceptance Limits for the New ICH USP 29 Content-Uniformity Test
| | | By
James S. Bergum
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Hua Li, PhD
| | | Revisions to the United States Pharmacopeia's (USP) uniformity test require manufacturers to establish new acceptance limits. The authors present their method for calculating acceptance limits consistent with USP's revised content-uniformity test requirements.
| | | Converting Intravenous Dosing to Subcutaneous Dosing With Recombinant Human Hyaluronidase
| | | By
Michael F. Haller
| | | The preferred route of administration for an injected therapeutic agent is subcutaneous (SC), but SC injections are generally limited to no more than 1-2 mL in volume, representing a major challenge, especially for large protein biologics.
| | | The Application of Quality by Design to Analytical Methods
| | | By
Phil Borman
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Phil Nethercote
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Marion Chatfield
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Duncan Thompson
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Keith Truman
| | To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.
This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).
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| Advancing ODT Technology
| | | By
Patricia Van Arnum
| | | Orally disintegrating tablets (ODTs) continue to attract attention as an alternative to conventional oral dosage forms.
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| Who's in Charge?
| | | By
Michelle Hoffman
| | | Courts are denying the terminally ill access to experimental drugs, leaving many with no options.
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| We Need More Overseas Inspections
| | | By
Angie Drakulich
| | | Offshore contracting is nothing new for the pharmaceutical industry. Neither is importing active ingredients, or prescription drugs, for that matter. But the authorities are having trouble keeping up with these growing international trends.
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| Charting a Path to Purity
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| | By
Sanjay Garg, PhD
| | | Regulators and industry professionals provide a guide for identifying and measuring impurities.
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| In the Field
| | | The United States House of Representatives passed its version of the Patent Reform Act of 2007 (H.R. 1908) in September in a 220-175 vote. Although the bill aims to fix current flaws in the US patent system and to bring it in line with those of other countries' systems, the biopharmaceutical industry is largely unhappy with the news, arguing that it will reduce patent protection.
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| In the Spotlight
| | | Carl Zeiss MicroImaging (Thornwood, NY) recently introduced its "Colibri" light-emitting diode (LED) light source for fluorescence microscopy. The product is "the only LED light source optimized for white-field microscopy systems," says Becky Homan, product manager for biomedical light microscopy.
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| Pharma Capsules
| | | Lancaster Laboratories (Lancaster, PA) acquired Microchem Laboratories (Waterford, Ireland). Microchem was established in 1986 and is one of Ireland's testing and research laboratories. Microchem offers microbiological, chemical, and environmental analyses to the pharmaceutical, medical-device, and chemical industries in Europe and Asia.
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Speed, Resolution, Reproducibility, Flexibility, Durability: Unmatched in sample throughput & data precision, Shimadzu's Prominence Ultrafast LC (UFLC) delivers data without compromise. Learn more.
Processing & Packaging Online Auction - November 24th, 2009 - 9-4 ET
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Buy new and used pharmaceutical equipment, used process equipment and laboratory equipment at LabX. Auctions, classifieds, and post FREE wanted ads to locate equipment.
Swagelok® DR series valve design saves space, minimizes entrapment, extends diaphragm life. See how.
Applying E-Commerce to Support Discovery and Development of Medicines: Key Lessons and Learnings Tuesday, December 15 @ 11:00 a.m. ET
Million Dollar Biotech & Pharmaceutical Equipment Online Auctions