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Biomedical subjects

M E Haffner

Publications and source records attributed to M E Haffner.

11 recordsLinked to original sources
PubMed1992

Evaluation of orphan products by the U.S. Food and Drug Administration.

Orphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

Drug Approval↗
PubMed1976

The relative efficacy of vestibular-proprioceptive stimulation and the upright position in enhancing visual pursuit in neonates.

48 healthy neonates born to multiparae were randomly assigned to view a moving stimulus either in the horizontal or the upright position, with or without added vestibular stimulation and with or without pacifier sucking. The infant was shown a moving black line inside a strictly controlled visual environment provided by an apparatus which permitted horizontal and upright positioning and displacement of the infant. Visual tracking was recorded by a concealed TV camera positioned at a constant distance and angle from the infants' eyes in both positions. Quality of tracking during each of 4 trials was scored on a 7-point scale. Results indicate that vestibularproprioceptive stimulation provided to the infant either horizontally or semivertically significantly enhanced his visual tracking, whereas the upright position did not. Pacifier sucking also improved his performace.

Eye Movements↗
PubMed1975

Effects of waterbed flotation on premature infants: A pilot study.

Two types of waterbeds were developed to impart compensatory vestibular-proprioceptive stimulation to premature infants. Twenty-one infants ranging in gestational age from 27 to 34 weeks and birthweights from 1,050 to 1,920 gm were included in this pilot study. Assignment to experimental and control groups was made by random design. The experimental group consisted of ten infants who were placed on a gently oscillating waterbed before the sixth postnatal day, where they remained for seven days. Their clinical progress was compared with that of a control group of 11 similar babies. Waterbed flotation was found to be a safe procedure; there was no significant effects on the infants' vital signs, weight, or frequency of emesis. Highly significant differences were found in the incidence of apnea between the two groups, with infants on the oscillating waterbed having significantly fewer apneic spells. Infants placed on the waterbed during the first four postnatal days benefited more than those placed later. A non-oscillating waterbed was found clinically useful for very small prematures with severe skin problems, for infants recovering from abdominal surgery, and for infants receiving parenteral nutrition.

Apnea↗