Several good manufacturing practice (GMP) compliance issues and their associated quality problems that have been revealed since 2020 have led to large-scale recalls and supply suspensions of drug products in Japan. This paper provides an overview of the causes and countermeasures for supply disruptions of low-molecular-weight chemical pharmaceutical agents, focusing on quality-related issues. A recent increase in the use of generic drugs emphasized the importance of strengthening active pharmaceutical ingredient (API) supply chains and ensuring GMP compliance among drug manufacturers.
View Article and Find Full Text PDFClinical Description: A 61 year old man presenting with subarachnoid haemorrhage had a distal posterior inferior cerebellar artery (PICA) aneurysm diagnosed on the initial cerebral angiogram. However, a PICA aneurysm was not found during surgery. A follow-up, super-selective vertebral artery (VA) performed demonstrated a saccular aneurysm located on the lateral spinal artery (LSA).
View Article and Find Full Text PDFA 21-year-old febrile woman with sudden onset of headache and semicoma was transferred to our institute. CT and 3D-CT angiography showed subaracnoid hemorrhage and intracranial hemorrhage in the left hemisphere due to a saccular aneurysm at the occluded M2 portion of the middle cerebral artery (MCA). Her present illness started with a toothache and lumber pain 3 weeks earlier.
View Article and Find Full Text PDFWe present two cases in which the diagnosis was complicated by the presence of a weak muscle innervated by a compressed motor root in the intervertebral foramen (IVF) at an atypical level. The patients were 59- and 53-year-old men; they presented with marked atrophy and weakness predominantly in a unilateral deltoid. Neuroimaging revealed narrowing of the nerve root sleeve at the C5/6 IVF due to a herniated disk or osteophyte.
View Article and Find Full Text PDFApplication of sutures between expanded polytetrafluoroethylene (ePTFE) dural substitutes and the dura mater is often frustrating in posterior fossa surgery because of the difficulty in holding the elastic graft in a deep and narrow field. To resolve this problem, we have developed a boat-shaped graft made from a triangular ePTFE sheet by pinching each angle using a suture. Formation of standing edges of the sheet facilitates holding of the flaps for secure and more rapid suturing than the conventional approach using a flat sheet.
View Article and Find Full Text PDFNeurol Med Chir (Tokyo)
December 2006
A 46-year-old woman presented with hemorrhage from a non-functioning pituitary adenoma manifesting as sudden onset of severe headache. Computed tomography demonstrated diffuse subarachnoid hemorrhage (SAH) and a suprasellar mass with intratumoral hematoma. The patient underwent transnasal transsphenoidal removal of the pituitary adenoma.
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