BACKGROUND Recombinant human growth hormone (rhGH) can increase the growth rate in growth hormone deficient children (GHD). In this randomized clinical trial, we compared the efficacy and side effects of an Iranian brand; Samtropin with Norditropin. METHODS The GHD children were randomly treated either with standard dose of Samtropin or Norditropin rhGH for one year. Upstanding height, height...

INTRODUCTION This ongoing, prospective, open-label, non-comparative, multicenter phase IV study is evaluating the safety and efficacy of recombinant human growth hormone (rhGH; Omnitrope(®), Sandoz GmbH) in short children born small for gestational age (SGA). Here we report data from patients who have completed 2 years' treatment. METHODS Eligibility criteria included prepubertal children bor...

UNLABELLED BACKGROUND Growth rate In children is reported to have seasonal variability. There are fewer published data regarding seasonal variability while on growth hormone (GH) therapy, and none analyzing growth rate with respect to number of daylight hours. METHODS We analyzed 11,587 3-month intervals in 2277 prepubertal children (boys ages 3-14 years, girls ages 3-12 years) with idiopa...

CONTEXT There is great interindividual variability in the response to recombinant human (rh) GH therapy in patients with Turner syndrome (TS). Ascertaining genetic factors can improve the accuracy of growth response predictions. OBJECTIVE The objective of the study was to assess the individual and combined influence of GHR-exon 3 and -202 A/C IGFBP3 polymorphisms on the short- and long-term o...

The manuscript by Flodmark et al. [1] recently published in the open-access journal Biologics in Therapy describes a single-center experience in Sweden of a switch from an originator biologic to a biosimilar human growth hormone (rhGH) using a dialogue teamwork approach [1]. Unfortunately, the authors fail to mention several limitations to their study which call into question their conclusions....

Introduction. Yeasts are widely used in production of recombinant proteins (r-proteins) of medical or industrial interest. For the production of a biomolecule in a host a creative metabolic engineering design is achieved, and then optimized both on the molecular genetic and fermentation level, by taking into account the properties of the product, the host organism and the expression cassette. A...

Abstract Recombinant human growth hormone (rhGH), the mainstay of hGH replacement therapy, is injected daily for years to enable children achieve normal stature. Daily rhGH injections are required because its serum-T1/2 <20 minutes. Human trials testing T1/2-extending proteins promising, but even weekly administration poses potential short and long-term toxicity risks, including exacerba...

OBJECTIVE To identify parameters which predict individual growth response to recombinant human GH (rhGH) therapy and to combine these parameters in a prediction model. DESIGN Fifty-eight prepubertal patients with GH deficiency (17 females) participated in this prospective multicenter trial with 1 year of follow-up. METHODS Auxological measurements, parameters of GH status and markers of bon...

We adapted one of the in-vitro immunization methods to induce antibody responses and confirmed the success of the immunization by enzyme-linked immunosorbent assay (ELISA) without hybridization. We have previously reported several methods of in-vitro immunization using different conditioned media. Here we introduce another method of in-vitro immunization using a mixture of three types of supern...