Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized as safe and effective (GRASE) and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products.     

A guide to the best technology-transfer practices

In analyzing the best technology-transfer practices of a broad cross-section of goverment agencies, research institutions, and national and industrial laboratories, it was found that different technology-transfer practices should be used at the prospecting, developing, trial, and adoption stages of technology transfer. These results are summarized in a benchmark model that indicates which best practices to use at each stage of the technology-transfer process, and what roles should be played by technology disseminators, developers, sponsors, and implementors during these stages. Rules are suggested for making cost-effectiveness trade-offs among alternative best practices and designing optimal transfer strategies when budgets are limited.     

A simple histochemical technique for the identification of gunshot residue

Alizarin red S (ARS) is a commonly used organic dye useful in the histologic identification of calcium deposits. ARS also forms colored reaction products with other metal ions, including barium and lead, which are present in primer residue. In histochemical studies, ARS is shown to identify primer residues from several manufacturers as well as primer residue deposited in tissue, either experimentally or in close-range gunshot wounds. This can be easily accomplished with routine histologic techniques. ARS does not stain gunpowder residue, tattoo pigment, melanin, graphite, india ink, or anthracotic pigment.     

A study on the standard for forensic anthropologic identification of skull-image superimposition

By means of X-ray photography tests were made of 224 (100 males and 124 females) volunteer Chinese adults of Han nationality to study the related regular patterns of superimposed projection of face landmarks onto the skull. On the basis of these tests, the present article reveals from a forensic anthropology angle the related regular patterns of plane projection of the human face with its skull. Study shows that there exist a strict individual identity and exclusiveness in relation between the human face and skull. The related regularity of displacement of face landmarks appears in projection of the skull with the human head at different photographic positions and angles. On the basis of this discovery, 52 indexes in 4 groups were established as a standard for judging the identification of a skull's body origin by means of skull-image superimposition. Based on forensic anthropology, the technique has raised to a great extent the credibility of unknown skull identification. In the past 8 years, 89 unknown skulls have been identified with their body origins which provided important and accurate evidence for the solution of murders with dismembered bodies, skeletonized bodies, and unidentified dead bodies.     

A theory of identification

This paper analyzes the phenomenon of “identification” by an individual with actors in his environment. It argues that individuals interpret their environment according to “frames,” which they, as recipients of a message, derive by a complex process of interpretation of the communication setting. The paper also argues that individuals identify with actors in their environment, because this identification increases their utility vis-à-vis a “neutral” watching of their environment. The paper applies this approach to a variety of real life examples, in particular to voting.     

A post-processing technique for cranial CT image identification

Objective: A major challenge in radiographic identification is the inconsistent orientation between clinical (ante-mortem, AM) and post-mortem (PM) radiographs. The objectivity and accuracy of radiological identification would be greatly enhanced by post-processing techniques that allow quantitative comparison of PM CT data in the same orientation as the AM CT data. Methods: We applied a post-processing technique to reposition a multislice computed tomography (MSCT) scan for spatial registration with a CT radiograph from the same patient. A second set of MSCT images from different individuals served as the non-matched control group. The consistency in radiographic positioning eliminated subjectivity in the comparison and identification process because the radiograph superposition provided objective evidence that confirmed the identification with fine detail. Results: A quantitative comparison with statistical validation was achieved by measuring a set of 14 landmarks from the images. Discrimination of identity based on logistic regression analysis of the earlier CT patient scans (the AM group) versus subsequent MSCT scans (the PM group) was objective and reliable. Conclusion: This quantitative comparison depends less on subjective judgment and the experience of the examiner, and so may meet legal standards.     

A new algorithm for use in computer identification

On 9 May 1987, a Soviet-made IL-62M Polish airliner, LOT Flight 5055, crashed, exploded, and burned, killing the crew and 183 passengers. A forensic science team from the Armed Forces Institute of Pathology, comprised of 6 dental officers, 3 forensic pathologists, and 3 medical photographers, worked in concert with the Polish forensic science team. The small number of antemortem records and the extreme fragmentation of the remains presented a new scenario for computer use. Typically, the Computer-Assisted Postmortem Identification (CAPMI) software is used to compare remains against an antemortem database. Results are listed by the number of tooth-to-tooth matches based on restorative or other characteristics or both. The Polish disaster confounded this approach to some degree, however, and suggested a reconsideration of the theory on which the sort is made, that is, that the cases with maximum number of matches to preexisting dental records would be the most likely identification (ID) match. A hypothesis was constructed that, if searches were accomplished for fragments with a minimum number of mismatches, the correct matches would appear higher in the rank order. Six antemortem records (that had all dental information) were sorted against one hundred and twelve postmortem fragmented records. The resulting report was reordered so that records were listed by minimum number of mismatches. There was significant improvement in rank placement for all of the records. Thus it was accepted that in the situation of highly fragmented remains a different sorting based on the number of mismatches is indicated. Programming changes to make this option available have been implemented in the new version of CAPMI.     

A multi-enzyme electrophoretic system for the identification of seminal fluid from postmortem specimens

The screening of autopsy specimens, vaginal, buccal, and rectal swabs, for the presence of seminal fluid in rape homicide investigations utilizing classical techniques can lead to erroneous results. In the absence of spermatozoa, techniques are needed which can help to identify seminal fluid. This report illustrates the use of a multi-enzyme electrophoretic approach identifying seminal acid phosphatase (SAP) and lactic acid dehydrogenase (LDH-X) as an initial screening procedure. Subsequent analyses for the presence of acid and alkaline phosphatase (semiquantitative) yield information which can help identify false-positive SAP's. Additionally, salivary amylase can be tentatively identified using the same multi-enzyme procedure which informs the investigator of possible salivary contamination of the sample and possible erroneous PGM results. Statistics utilizing the multi-enzyme approach in case work are also presented.     

A comprehensive ATR-FTIR spectroscopic analysis for the identification and differentiation of lip balms

Lip balm may be encountered as physical evidence in cases involving sexual assaults, homicides, and kidnappings. Lip balm can be used as corroborative evidence by providing a potential link between the victim, accused, and the crime scene. For lip balms to be used as evidence, it is important to understand the diversity and their aging process under different conditions. Therefore, in this study, ATR-FTIR spectroscopy in conjunction with chemometric tools such as principal component analysis (PCA) and linear discriminant analysis (LDA) has been used for the objective identification and differentiation of 20 brands of lip balms. Moreover, lip balms on different substrates and wearing effects over time were also investigated. The results show that the PCA-LDA training accuracy was 92.5%, whereas the validation accuracy comes out to be 83.33%. A blind study using pristine samples was also performed which resulted in 80% PCA-LDA accuracy. PCA-LDA prediction of samples on various substrates showed a higher chemometric prediction accuracy for nonporous substrates (glass, plastic, and steel), than for porous substrates (cotton cloth, cotton swab stick, dry tissue paper, and white paper) for samples kept in room temperature and under sunlight for 15 days. The substrate study showed that the samples from various substrates could effectively generate respective spectra which can help in brand-level identification even after several days. The present method demonstrates a potential for lip balm samples to be used in forensic casework applications.     

A short note on the identification of mitragynine

The leaves of Mitragyna speciosa are used as a substitute for opium. Criminal penalties for possession of mitragynine in this country are assigned for possession of defined quantities of mitragynine and its identification as Mitragyna speciosa by thin-layer chromatography and gas chromatography.