The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children.

Background: Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment of Paediatric Investigation Plans (PIPs). The effect of the EU Paediatric Drug Regulation on the marketing authorisation (MA) of drugs for children with rare diseases was studied.

Computed tomography and low-field magnetic resonance imaging of the pituitary gland in dogs with pituitary-dependent hyperadrenocorticism: 11 cases (2001-2003).

Objective: To compare the results of computed tomography (CT) and magnetic resonance imaging (MRI) of the pituitary gland in dogs with pituitary-dependent hyperadrenocorticism (PDH) caused by histologically confirmed pituitary adenoma.

Design: Retrospective case series.

Animals: 11 dogs with PDH that underwent transsphenoidal hypophysectomy.

Dynamic helical computed tomography of the pituitary gland in healthy dogs.

Dynamic helical computed tomography (CT) of the pituitary gland can be used to image the three-dimensional shape and dimensions of abnormalities within the pituitary gland. The aim of this study was to develop a protocol for dynamic helical CT of the pituitary gland in healthy dogs as a future reference study for patients with pituitary disease. Dynamic helical series of nine scans of the pituitary gland during and following contrast medium injection were performed in six healthy dogs using the following protocols: a series with 1 mm collimation and a table feed per X-ray tube rotation of 2 mm (pitch of 2) in six dogs, a series with 2 mm collimation and pitch of 2 in three dogs, and a series with 1 mm collimation and pitch of 1 in three other dogs.

Thin-slice three-dimensional gradient-echo magnetic resonance imaging of the pituitary gland in healthy dogs.

Objective: To evaluate thin-slice 3-dimensional gradient-echo (GE) magnetic resonance imaging (MRI) of the pituitary gland in healthy dogs.

Animals: 11 healthy dogs.

Procedures: By use of a 0.

Intraobserver and interobserver agreement, reproducibility, and accuracy of computed tomographic measurements of pituitary gland dimensions in healthy dogs.

Objective: To determine the reproducibility and accuracy of computed tomographic (CT) measurements of pituitary gland dimensions in healthy dogs.

Animals: 35 healthy sexually intact adult dogs.

Procedures: 2 observers independently viewed CT images of the skull in 35 dogs twice.

Dynamic computed tomographic evaluation of the pituitary gland in healthy dogs.

Objective: To determine the contrast enhancement pattern of the pituitary gland in healthy dogs via dynamic computed tomography (CT).

Animals: 17 dogs.

Procedure: With each dog in sternal recumbency, transverse CT scans were made perpendicular to the skull base from the rostral clinoid processes to the dorsum sellae.

Dynamic computed tomography of the pituitary gland in dogs with pituitary-dependent hyperadrenocorticism.

Dynamic computed tomography (CT) of the pituitary gland was performed in 55 dogs with pituitary-dependent hyperadrenocorticism (PDH) that underwent transsphenoidal hypophysectomy. On routine contrast-enhanced CT images, microadenomas of the pituitary gland often are indistinguishable from nontumorous pituitary tissue because of isoattenuation. Dynamic CT may allow visualization of these adenomas.

Imaging of the pituitary gland in dogs with pituitary-dependent hyperadrenocorticism.

Detailed imaging of the pituitary gland is a prerequisite for a successful outcome of transsphenoidal hypophysectomy in dogs because it allows for accurate preoperative localization and assessment of the size of the pituitary gland. Cisternography allows assessment of even small increases in the height of the pituitary gland, but the magnitude of suprasellar expansion of pituitary tumors cannot be assessed with this technique. Large pituitary tumors with suprasellar expansion can readily be detected with conventional contrast-enhanced computed tomography (CT), while pituitary microadenomas can be localized with dynamic contrast-enhanced CT.