Investigational drugs and research

This chapter will define investigational use for clinicians and outline FDA policies in this area in a simple and pragmatic way. Instances in which investigational use would require application to the FDA for an investigational New Drug Exemption (IND) and instances in which their use would require approval by an Institutional Review Board (IRB) will be described and examples given.     

Vitamin E deficiency secondary to chronic intestinal malabsorption and effect of vitamin supplement: a case report.

We report the clinical, neurophysiological (comprehending electromyography, nerve conduction velocities, and multimodal evoked potentials), histological study of the nerve and muscle and the effect of vitamin E supplement in a 32-year-old case with chronic vitamin E deficiency subsequent to acquired intestinal malabsorption. An early diagnosis for an early treatment is essential in preventing severe neurological deterioration.     

Effect of selenium on the connective tissue metabolism in rats]

Rats were chronically exposed to poisonous sodium selenite in concentrations 0.5 mg/kg b. m. for 10 weeks. As a result, hydroxyproline contents in blood serum increased, as well as its excretion with urine. It was proved that the procedure enhanced urinary glycosaminoglycane excretion and increased the contents of the protein-related glycosaminoglycanes in the serum. This was accompanied by increased quantities of keratane sulphate and heparin sulphate. The results confirmed that selenium poisonings influenced connective tissues.     

HEAD CIRCUMFERENCE AND INTELLECTUAL PERFORMANCE OF PATIENTS WITH DUCHENNE MUSCULAR DYSTROPHY

The head circumferences of 64 patients with Duchenne muscular dystrophy were measured and found to be greater than those of a normal population. The patients had relative, and in 12 cases, absolute macrocephaly. 47 of the 64 patients underwent intelligence testing and were found to be significantly intellectually impaired, particularly in verbal and language skills. There was no correlation between head circumference or absolute macrocephaly and intellectual performance. The cause of macrocephaly in these patients is unknown and its relevance to the aetiology of intellectual impairment in Duchenne muscular dystrophy is not yet clear.     

Clinical Observations of Porcelain Veneers: A Three-Year Report

One hundred and sixty-five Cerinate porcelain veneers were placed by 11 private practice clinicians from diverse locations throughout the USA. The veneers were evaluated over a 3-year service period using Kodachrome photographs and grading of clinical characteristics by evaluators. The following factors were evaluated: (1) esthetics; (2) margin fit; (3) margin discoloration; (4) breakage; (5) gingival irritation; (6) patient acceptance; and (7) caries. Specific characteristics and their evaluations over three years were: (1) Esthetics started out excellent and remained that way; (2) Margin fit was acceptable at the beginning of the study and was actually perceived to improve, perhaps related to cement at the margins wearing and smoothing; (3) Margin discoloration started very low and became slightly worse; (4) Breakage was present during each of the 3 years, and 13 percent of veneers had some breakage after 3 years. Changes in clinical procedures are suggested in this paper to diminish this problem; (5) Gingival irritation was minimal throughout the study; (6) Patient acceptance was excellent at the beginning of the study and improved; and (7) Dental caries involvement was minimal, with only one veneered tooth showing caries involvement. Over the 3-year period, the veneers provided excellent service overall.     

Effect of long-term treatment of two tobacco-specific N-nitrosamines on the vitamin A status of mice

The effect of long-term treatment of two important tobacco-specific N-nitrosamines, N'-nitrosonornicotine (NNN) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), on the depot or circulating levels of vitamin A of Swiss and BALB/c male mice was studied. It was observed that treatment of both NNN and NNK in Swiss and BALB/c mice decreased liver vitamin A levels significantly. NNK treatment also caused a decrease in the levels of vitamin A in plasma.