ABSTRACT. The molecular basis of recombinant DNA technology is described, and the principles of genetically engineered proteins developed. The production of hGH by such methods utilizes a strain of Escherichia coli as host and a vector plasmid containing the appropriate information. Fermentation and purification of the hGH produced gives a preparation of high purity, containing only 1–2 ppm of E. coli polypeptide (ECP). This somatrem (Somatonorm) is identical to pituitary hGH except for an additional methionine residue at the N‐terminal. Monoclonal antibodies fail to distinguish between pituitary hGH and somatrem. Preclinical studies of a variety of pharmacological and toxicological parameters indicate that the two hGH preparations have identical biological effects; no toxicological or mutagenic effects of somatrem have been detected.
Vitamin BIZ is of importance for basic metabolic processes and is necessary for normal growth and reproduction in animals and some micro-organisms. Many different metabolic functions have been ascribed to the vitamin by various investigators, including participation in the synthesis of nucleic acids.It has been claimed that patients with neoplasms have a higher requirement for vitamin B12. The present investigation was made to study the accumulation of labelled vitamin B12 in some transplanted tumours and gain information on the degree of uptake in neoplastic, as compared to normal, tissues. MATERIAL AND METHODSThe labelled compounds used were vitamin B,, --T O , specific activity 109 and 255 mc/mg, vitamin B12-T O , specific activity 170 mc/mg and vitamin B,z-finCo, specific activity 4.68 mc/ mg. All the preparations were obtained from Philips-Duphar (Holland). The vitamin B,,-5*Co and vitamin B12 -'j°Co preparations were used in the autoradiographic studies, vitamin B , -"CO in the quantitative investigations. Tumours and transplantation procedureFour different kinds of tumour were used in the investigation, CBA mice carrying "Sr-induced
Since 1978 the Swedish catalogue of registered pharmaceutical specialities (FASS) has carried a special section entitled “Pregnancy and breast‐feeding” in each product presentation, intended to form an aid for the prescription of drugs to women during child‐bearing and lactation. After a brief review of transplacental transport and milk secretion, reproduction‐toxicology studies in animals, and methods for clinical evaluation of drugs for use during pregnancy, the classification system is presented. On the basis of available data with regard to effects on early and late stages of pregnancy and labour, all the pharmaceutical specialities concerned are assigned to one of the following pregnancy categories: A, B 1, B 2, B 3, C or D. The letters refer to information based on findings in man, and the figures to information based on animal data. For drugs in categories B 3, C or D any harmful effects observed or likely to occur in man or animals are to be specified. The pregnancy categories are defined as follows: Category A. Drugs which may be assumed to have been used by a large number of pregnant women and women of child‐bearing age, without any form of definite disturbance in the reproductive process having been noted so far, e.g. an increased incidence of malformations or other direct or indirect harmful effects on the fetus. Category B. Drugs which may be assumed to have been used by only a limited number of pregnant women and women of child‐bearing age, without any form of definite disturbance in the reproduction process having been noted so far, e.g. an increased incidence of malformations or other direct or indirect harmful effects on the fetus. Category C. Drugs which by their pharmacological effects have caused, or must be suspected of causing disturbances in the reproduction process that may involve risk to the fetus without being directly teratogenic. Category D. Drugs which have caused an increased incidence of fetal malformations or other permanent damage in man or which on the basis of e.g. reproduction‐toxicology studies must be suspected of doing so. This category comprises drugs with primary teratogenic effects. If the drug also has pharmacological effects that may directly or indirectly have a harmful effect on the fetus, this must also be stated. As experience of effects of drugs in Category B is limited, results of reproduction‐toxicology studies in animals are indicated by allocation to one of three subgroups according to the following definitions: Category B 1. Reproduction‐toxicology studies have not given evidence of an increased incidence of fetal damage or other deleterious effects on the reproduction process. Category B 2. Reproduction‐toxicology studies are inadequate or may be lacking, but available data reveal no evidence of an increased incidence of fetal damage or other deleterious effects on the reproduction process. Category B 3. Reproduction‐toxicology studies have revealed an increased incidence of fetal damage or other deleterious effects on the reproduction process, the significa...
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