drug administration Downloads
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Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) Environmental Monitoring Requirements - Application Note
The Food and Drug Administration (FDA) requires human cell, tissue, and cellular and tissue-based product establishments to follow the current Good Tissue Practice (GTP), which governs the methods used in, and the facilities and controls used for, the manufacture of human tissue and cellular and tissue-based products. The following regulation is to be enforced as of May 25, 2005: 21 CFR ...
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Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements - Application Notes
Introduction Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. The importance of record-keeping in ...
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Model ACAM2000 - Vaccinia Virus Brochure
ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) is a live, vaccinia virus smallpox vaccine licensed in the U.S. by the Food and Drug Administration for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. It was developed under a contract with the U.S. Centers for Disease Control and Prevention ...
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Biomedical - Model Snap - Administration of Drug Tablets - Brochure
Made of transparent plastic, aseptic, with an innovative design and removable parts, it makes the work of doctors and nurses faster and easier. ...
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MasterControl - Training Management Software - Brochure
Employee training is an integral part of compliance with the U.S. Food and Drug Administration (FDA) and other international quality management regulations. Ensuring all staff members remain fully qualified for their roles requires strict attention to many details in overseeing the skills development of each employee. MasterControl Training automates all training tasks, including records ...
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Biosynth - Model YP29207 - Polydextrose - Datasheet
Polydextrose is a synthetic polymer of glucose. It is a food ingredient classified as soluble fibre by the U.S. Food and Drug Administration (FDA) as well as Health Canada, as of April 2013. It is frequently used to increase the non-dietary fibre content of food, to replace sugar, and to reduce calories and fat content. It is a multi-purpose food ingredient synthesized from dextrose (glucose), ...
By Biosynth Ltd
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Vaccine Safety Monitoring Services Brochure
and Drug Administration (FDA) ensures the safety, effectiveness, and availability of ...
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RoweMed - Model RowePhil 18 - Hydrophilic Injection Filter Datasheet
Hydrophilic injection filter for protection against particle and bacterial contamination of small amounts of drugs during administration; Different connectors are available; Filter area 2.3 cm²; Filter diameter 18 mm; Compatible with all Luer-Lock connectors; Low priming volume. ...
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RoweMed - Model RowePhil 25 - Hydrophilic Injection Filter Datasheet
Hydrophilic injection filter for protection against particle and bacterial contamination of small amounts of drugs during administration; Compatible with all Luer-Lock connectors; Filter diameter 25 mm; Filter area 4.0 cm²; Low priming volume. ...
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Micro-Media - Pharmaceutical P-Grade Filter Pads Brochure
with ErtelAlsop Drug Master File located at the United States Food and Drug Administration Center for ...
By ErtelAlsop
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Cellene - Model MC1053 - Thermoplastic Elastomer Compounds - Datasheet
CELLENE™ MC1053 is a high clarity, nontoxic, halogen and phthalate free, flexible thermoplastic elastomer compound developed specifically for extrusion applications in the food and medical industries. All components used in the manufacturing of CELLENE™ MC1053 are sanctioned by the US Food & Drug Administration for food applications under Title 21 of the Code of Federal ...
By Tekni-Plex
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MAD Nasal Factsheet
Medication Delivery The MAD Nasal Device from Teleflex was invented by an emergency physician and offers a useful, additional option in the choice of alternate access for medication delivery.* Rapidly Effective Nasal drug administration with the MAD Nasal Device is quick and easy, eliminating IV set-up time and conserving resources. Additionally, no sterile technique is required, so more time is ...
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SIGA - Model TPOXX - Vaccines for Smallpox Datasheet
Oral TPOXX® (tecovirimat) is the first drug approved by the U.S. Food and Drug Administration (FDA) that is specifically indicated for the treatment of smallpox disease in adults and pediatric patients weighing at least 13 kg. (Prescription Label) TPOXX® inhibits viral maturation of variola virus (the virus that causes smallpox) and other poxviruses by preventing the formation of a ...
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emka - Perfusion Systems - Brochure
Especially designed for mice, rats, guinea-pig and rabbits, our perfusion systems are used in pharmacological research and Toxicology, to investigate liver, kidney or mesenteric beds vascular activity and physiology, in response to drug challenges. The system provides heated, oxygenated, and nutrient-rich perfusate to the organ with or without drug administration and electrical ...
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Phoenix WinNonlin SoftwareBrochure
PK/PD and non-compartmental analyses can be time consuming, requiring detailed attention to every step from data preparation to report generation. Phoenix WinNonlin™’s integrated tools for data processing, graphing & charting, report generation, and compliance create an efficient, all-in-one collaboration workbench. Phoenix WinNonlin is used by over 10,000 scientists at more than ...
By Certara
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Birmingham - Model HIP - Resurfacing System - Brochure
The BIRMINGHAM HIP◊ Resurfacing (BHR◊) System is a conservative approach to hip arthroplasty in which an all-metal bearing couple is used to preserve, rather than replace, a patient’s femoral head and neck. It was first implanted in July 1997, and was approved for use in the United States by the Food and Drug Administration in 2006. Since its introduction, there have been over ...
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iPRECIO SMP-200 Brochure
The iPRECIO programmable pump is an advanced infusion device for drug delivery applications in mice, rats and larger animals. With versatile programmable functions and a refillable reservoir, this implantable infusion pump enables full control over dosing studies and empowers researchers to execute even the most complex dosing protocols, including multiple bolus dosing, variable/constant ...
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Tianlong - Model GeneRotex48 - Nucleic Acid Extraction Instrument Brochure
The GeneRotex48 Nucleic Acid Extraction Instrument, as the latest generation of Tianlong Technology products, is specifically designed for nucleic acid extraction of large-volume samples. Designed according to the principles of magnetic bead method and rotary nucleic acid extraction technology, GeneRotex48 can achieve the rapid and efficient preparation of nucleic acids from large-volume samples. ...
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Tianlong - Model GeneRotex96 - Rotary Nucleic Acid Extractor Brochure
Tianlong GeneRotex96 Rotary Nucleic Acid Extraction System,designed according to the principles of magnetic bead method and rotary nucleic acid extraction technology, GeneRotex 96 can well overcome the shortcomings of traditional nucleic acid extraction methods and achieve the rapid and efficient preparation of nucleic acids from a large number of samples. With the appropriate nucleic acid ...
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Tianlong - Model Libex - Nucleic Acid Extractor Brochure
Based on the automated extraction method of magnetic bead adsorption separation, Tianlong Libex Nucleic Acid Extractor can well overcome the shortcomings of conventional nucleic acid extraction methods and achieve rapid and efficient sample preparation. With the appropriate nucleic acid extraction reagents, it can process serum, plasma, whole blood, swabs, amniotic fluid, feces, tissue and tissue ...
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