Biomedical subjects

Walter Hauck

Publications and source records attributed to Walter Hauck.

3 recordsLinked to original sources

PubMed2005

Equivalence studies for complex active ingredients and dosage forms.

This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograph in the United States Pharmacopeia-National Formulary helps practitioners and other interested parties understand how an article's strength, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufacturers, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.

Biotechnology↗

PubMed2002

Phase II: trial of twice weekly amifostine in patients with non-small cell lung cancer treated with chemoradiotherapy.

Twenty-four patients with non-small cell lung cancer received induction chemotherapy (paclitaxel, carboplatin) followed by concurrent thoracic irradiation (RT) and weekly paclitaxel. Acute esophagitis was scored weekly. Amifostine (AMI), 500 mg intravenously twice weekly, was added to the regimen in the second cohort of 12 patients. AMI was well tolerated. The incidence of grade 3 esophagitis was 18% in the initial 11 patients versus 9% in the AMI-treated patients. Mean esophagitis index (EI) was numerically lower in the AMI-treated patients than in the initial group (5.1 v 11.6, P =.14). The length of esophagus in the RT field was similar in both groups. Median survival time for all patients was 12.4 months. The EI, a novel measure of the severity and duration of acute esophagitis, may be reduced in lung cancer patients receiving AMI twice weekly with thoracic RT and paclitaxel. The effect of AMI was not caused by the shorter irradiated esophageal length. A phase III randomized trial is now open to assess the effect of AMI on esophagitis.

Acute Disease↗

PubMedDate not supplied

The accuracy of artificial neural networks in predicting long-term outcome after traumatic brain injury.

OBJECTIVE: This study compared the accuracy of artificial neural networks to multiple regression and classification and regression trees in predicting outcomes of 1,644 patients in the Traumatic Brain Injury Model Systems database 1 year after injury. METHODS: Data from rehabilitation admission were used to predict discharge scores on the Functional Independence Measure, the Disability Rating Scale, and the Community Integration Questionnaire. RESULTS: Artificial neural networks did not demonstrate greater accuracy in predicting outcomes than did the more widely used method of multiple regression. Both of these methods outperformed classification and regression trees. CONCLUSION: Because of the sophisticated form of multiple regression with splines that was used, firm conclusions are limited about the relative accuracy of artificial neural networks compared to more widely used forms of multiple regression.

Brain Injuries↗