Medical use product

The medically useful products demethyltetracycline and doxorubicin (adriamycin) were discovered by simple mutation of the cultures producing tetracycline and daunorubicin (daunomycin), respectively. The tectmique of mutational biosynthesis (mutasynthesis) has been used for the discovery of many new aminoglycoside, macrolide, and anthracycline antibiotics. In this tectmique, a non-producing mutant ( idiotroph ) is isolated and then fed various analogs of the missing moiety. When such a procedure leads to a return of antibiotic activity, it usually is due to the... 

Fast, low temperature curing mbber compounds can be prepared by initial heat prevulcanisation of the Hquid latex and are marketed commercially (Revultex, Doverstrand Corporation). Rubber deposited from these often needs tittle more heat than that required to dry the deposit, to achieve optimum tensile strength and elongation. Such compounds are often used by small companies manufacturing thin-wall dipped medical latex products, such as examination gloves, as few compound preparation facilities are needed by the dipping company. 

The EU will accept applications without supporting pre-clinical and clinical data, if it can be demonstrated that the active substances have been in well-established medical use in the Community for at least 10 years, with recognised efficacy and an acceptable level of safety. This route would be appropriate for many common over-the-counter (OTC) products. Safety and efficacy is supported by providing copies of published scientific literature as part of the submission that is, the submission relies on safety and efficacy data available in the public domain, as opposed to confidential data from authorised applications that is the cornerstone of generic applications. 

Obtain a thorough medication use history, including present and past drugs prescription and nonprescription drugs the patient s self-assessment of response and side-effect problems use of alcohol, tobacco, caffeine, and illicit substances and use of herbal products and dietary supplements, as well as any allergies and adherence difficulties. 

Table 1.4 Pharmaceutical companies who manufacture and/or market biopharmaceutical products approved for general medical use in the USA and EU...

Most interferons have now been produced in a variety of expression systems, including E. coli, fungi, yeast and some mammalian cell lines, such as CHO cell lines and monkey kidney cell lines. Most interferons currently in medical use are recombinant human (rh) products produced in E. coli. E. coli s inability to carry out post-translational modifications is irrelevant in most instances, as the majority of human IFN-as, as well as IFN- 3, are not normally glycosylated. Whereas IFN-y is glycosylated, the E. coli-derived unglycosylated form displays a biological activity similiar to the native human protein. 

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