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At least 37 records · Page 2Linked to original sources
PubMed1996

Quantification of polymerase chain reaction products: enzyme immunoassay based systems for digoxigenin- and biotin-labelled products that quantify either total or specific amplicons.

Enzyme immunoassays were developed for quantification of polymerase chain reaction (PCR) products, referred to as amplicons. Amplicons were dual labelled simultaneously by enzymatic incorporation of digoxigenin and biotin during PCR. For total amplicon quantification, Microfluor B polystyrene wells, compatible with chemiluminescent detection, were coated with streptavidin. Dual labelled amplicons were bound, treated with anti-digoxigenin antibody conjugated to alkaline phosphatase to complete the two-site sandwich immunoassay configuration, and detected by the chemiluminescence generated upon hydrolysis of a phosphate substituted dioxetane substrate, AMPPD. For specific amplicon quantification, the Microfluor B wells were coated with an unlabelled DNA probe complementary to the labelled amplicon target. Subsequent steps were performed as described above. This assay detects 2 pg of specifically amplified DNA. Chemiluminescent detection provides a linear range of four orders of magnitude for amplicon quantification. The non-radioactive labels are safe and stable. PCR as described here obviates the need for labelled primers and constitutes the initial report of concurrent dual non-radioactive labelling of DNA by a DNA polymerase.

Animals↗
PubMed2005

HL7 Structured Product Labeling - electronic prescribing information for provider order entry decision support.

Prescribing errors are an important cause of adverse events, and lack of knowledge of the drug is a root cause for prescribing errors. The FDA is issuing new regulations that will make the drug labels much more useful not only to physicians, but also to computerized order entry systems that support physicians to practice safe prescribing. For this purpose, FDA works with HL7 to create the Structured Product Label (SPL) standard that includes a document format as well as a drug knowledge representation, this poster introduces the basic concepts of SPL.

Drug Labeling↗
PubMed2003

Identification and management of oral isotretinoin use inconsistent with product labeling.

A pharmacy claims database was assessed retrospectively to analyze which antiacne medications patients had used in the six months before receiving oral isotretinoin. Before being given a prescription for oral isotretinoin, at least 47% of patients in the database, and possibly as many as 72%, had not received conventional therapy (at minimum, a topical retinoid and an oral antibiotic), as advised in the product labeling. A prior authorization policy restricting oral isotretinoin to patients who were unresponsive to a topical retinoid, at least two other topical medications, and two oral antibiotics reduced oral isotretinoin utilization by 47% and the per member per month spend by 35%.

Abnormalities, Drug-Induced↗
PubMed2000

[Labeling products of photochemical degradation of insulin with technetium (99mTc)].

Irradiation with UV light at a wavelength of 250 nm allows to convert disulphidic groups in the structure of insulin to free SH groups with high affinity to direct labelling with 99mTc. The amount of terminal SH groups depends on irradiation time. HPLC analysis revealed that while 34% of the original amount of insulin was present after 15 minutes of irradiation (approx. intensity of 500 microW.cm2), the amounts were 25%, 10%, and 2% after 30; 60, and 120 minutes, respectively. These results correlate with the amount of SH groups released by photoactivation measured using Ellman's reagent. The product of the degraded porcine insulin was labelled with 99mTc using the redox polymer RP G25 IDA under the following conditions: pH 6.8-7.9, labelling time 15 minutes, room temperature. Radiochemical purify of the labelled product was higher than 96%. Insulin and products of its degradation were evaluated by means of size exclusion chromatography (SEC). The biodistribution of the labelled substances in laboratory animals showed activity mostly in the kidneys and liver. No specific biodistribution of the labelled products was observed in rats with experimentally induced diabetes.

Animals↗
PubMed1986

An extensive review of commercial product labels the good, bad and ugly.

Cautions and warnings on consumer products play an important role in the prevention and treatment of poison exposures. Frequently those exposed will follow the directions before calling the poison center, physician or emergency room. An extensive label review of 200 commercial products was conducted to determine if medical treatment advice was correct, if the general public was able to comprehend warning statements, and if warnings were adequate. We conclude there are products available that provide precise, correct information. However, there are many that contain incorrect, misleading, and often dangerous information to an unsuspecting public. Various examples of both types are given to make the poison information specialist aware of what information is presented.

Drug Labeling↗
PubMed1994

The effect of alternative product-label design on warning compliance.

Many potentially hazardous products are packaged in small containers. Because of the limited amount of space available on these containers for warnings and other information, manufacturers often reduce the size and amount of printed material on the labels. This frequently impairs the message's legibility, noticeability and comprehensibility. Recently, several alternative label designs have been investigated using preference ratings, but whether the designs facilitate safer behaviour has not been determined. In the present experiment, two alternative designs (tag and wings) were compared with a conventional (control) design for their effect on behavioural compliance with a warning on a very small container of glue. Participants performed a parts-assembly task using the glue without being informed of the study's real purpose. Whether participants wore protective gloves as directed by the warning was measured. Results showed that the tag design produced significantly greater compliance than the other two designs. Measures of noticing, reading and recall of the warning mirrored the compliance results. While participants generally preferred the control label, they most preferred the tag warning. Overall, the results suggest that alternative designs like the tag can enhance warning communication and compliance in cases where surface area is limited.

Journal Article↗
PubMed1998

Prescription drug product labeling; medication guide requirements--FDA. Final rule.

The Food and Drug Administration (FDA) is establishing requirements for the distribution of patient labeling for selected prescription human drug and biological products used primarily on an outpatient basis. The agency is requiring the distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information. The intent of this action is to improve public health by providing information necessary for patients to use their medications safely and effectively. FDA believes that this program will result in direct improvements in the safe and effective use of prescription medications.

Community Participation↗
PubMed2004

Legal constraints in EU product labelling to mitigate the environmental risk of veterinary medicines at use.

This paper summarises what possibilities and obligations are created by the EU Directive 2001/82/EC on the registration of veterinary medicines to mitigate the environmental impact of the use of a veterinary medicinal product. More specifically, an identified environmental risk may be mitigated to an acceptable level by special precautions in the information that accompanies the product in labelling and packaging. These precautions can address the fate of contaminated slurry and treated animals, but are only acceptable under the EU Directive if their effect can be demonstrated using the risk assessment methodology. Next, all possible keepers of the animals or the manure, including third parties, should be addressed, either in the precaution, or in the national regulation that should enforce the precautions. A number of examples illustrate that some precautions used are not quantifiable in the risk methodology, and that others are legally inadequate. To render risk mitigation measures effective, hence suitable for labelling and packaging, it is imperative that the risk assessment methodology is further developed and applied adequately, and that the legality of precautions is established in national regulation, harmonised between Member States.

Algorithms↗