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The consultation services for “regular” drugs can cost as much as $20 blood pressure medication bad for you generic coreg 12.5mg with mastercard,000 for a typical product heart attack 720p movie download order coreg 6.25 mg visa. In the majority of orphan drug designations pulse pressure points generic 25 mg coreg with visa, fewer clinical trials in Japan are required for product approval than are required in the West blood pressure drops when standing discount 6.25mg coreg visa. The applicant may receive financial aid for the collection of supporting data, such as for conducting clinical trials, bridging studies, etc. Specifically, the applicant may receive as much as 50% of the cost of clinical development costs in financial aid, as well as tax exemptions of up to 12% of drug development/research costs Copyright © 2017 Pacific Bridge Medical. The application will be placed on a fast-track approval process, which generally proceeds much more smoothly than that of “regular” drugs. In theory, the fast track approval process takes 10 months while the approval for “regular” drugs takes 12 months. Product renewal for orphan drugs is every 10 years, versus every 4 to 6 years for other drugs. Although the exact fees vary depending on application type, total fees typically go down by about 25%. Shimoaraiso will explain the application process, including what information should be included with the application, which documents need to be translated, and whether any documents need to be revised. Date Attached Data Data on number of Statistical papers, interviews with Japanese doctors, 2 patients medical associations, etc. Explanation of why the drug is clinically superior to drugs already available in Japan (if applicable). Discussion of the scientific rationale supporting the use of 4 Scientific Rationale the drug for the rare disease/condition, including data from non-clinical laboratory studies, clinical investigations, etc. If any doctors in Japan already have experience using the drug, the applicant should ask the doctors to develop a Copyright © 2017 Pacific Bridge Medical. Date Address Name (Seal) To: Minister of Health, Labor and Welfare Source: Drug Approval and Licensing Procedures in Japan 2008 (Jiho, Inc. There is no regulation preventing more than one orphan drug designation and approval for the same indication in Japan. For instance, if a product is already on the market in Japan and designated as an orphan drug for the treatment of Disease A, this does not prevent another drug from receiving orphan drug designation and entering the Japanese Copyright © 2017 Pacific Bridge Medical. Japanese data is considered most supportive in terms of getting the product approved. It is best to target doctors focused on the specific disease/condition your drug treats in order to obtain the strongest support for your product. First, compile a list of potential doctors or Key Opinion Leaders who may be interested in your product. Introduce your orphan drug to these doctors and try to establish good working relationships with them. If a doctor obtains favorable results from your product, they may be willing to write a letter of recommendation to support your orphan drug application. Second, identify any related Japanese medical associations that may be interested in your drug. A representative from the association may also be willing to provide a letter of recommendation for your application if he/she sees the drug as beneficial. Keep in mind that obtaining support from a medical organization may require a small monetary donation ($5,000 $20,000). Doctors hold a very high status in Japanese society and are treated with the utmost authority. Therefore, it can be very difficult to make appointments with doctors, especially if one is requesting a face-to-face meeting. Very careful research by a professional consultant may be required to appropriately network with key doctors and obtain the necessary support. If the request is approved, the designation administrator will notify the applicant of his or her consultation date by phone or fax. The consultation itself takes around 30 minutes with a “sufficient” number of people appropriate to the applicant’s level of need. The applicant should submit five copies of the draft designation application (see next page), with other information attached, such as scientific evidence, research, literature, a list of references etc. Designation Consultation Form To: Person in charge of orphan drug designation, Pharmaceutical and Safety Bureau, Minister of Health, Labor and Welfare Company name Name of consulter (Name of participant and department) Phone number/Fax number Preferred date of consultation First choice: Second choice: Third choice: Name of substance to be designated Anticipated indications Matter to consult Source: Drug Approval and Licensing Procedures in Japan 2008 (Jiho, Inc. The preferred consultation day may not be available Attachment Form 2 Outline of Orphan Drug etc. Name Anticipated indications Name of applicant Target disease Indications of this drug for target disease Copyright © 2017 Pacific Bridge Medical. Sometimes, the company will be able to obtain their answer through these communications without meeting. Based on experience, there is usually a three to four-month wait between applying for a meeting and holding the meeting. The first in-person consultation meeting is normally free; future meetings usually require a fee. Around the time of the third meeting, the company should be able to provide information on how they plan to proceed with the clinical trials. The following other types of sessions are available for general drugs (see Table 5 below): Copyright © 2017 Pacific Bridge Medical. After approval by both groups, the drug is designated and a certificate will be sent to the applicant. Generally, the consultation applicant will be contacted within a few business days of request submission to set the future date of the consultation. At that time, the company will need to confirm the date and time of the consultation as well as the number of people attending. The meeting should begin with the drug company presenting their orphan drug development plan, including the drug development completed to date. This “official record” can be used as supportive information in the new drug application dossier. When applying for financial aid, a company is required to submit a very detailed protocol of its clinical trial plan and the expected costs broken down into yearly quarters. Normally, the Japanese government will assess the grant amount at half the company’s expenses (as defined below). It should be noted that the government expects payroll to be no more than 30% of total expenses. The financial aid covers the expenses incurred from the orphan drug development process, such as the following: Clinical trial costs. Travel expenses. Equipment costs. Printing fees. Communication fees. Leasing or user fees. Refreshments / boxed lunches at critical meetings. Payroll. Consumables (including investigational drug, test materials, animals, animal feed, etc. Since Japan’s national health insurance is universal, this can significantly improve sales prospects. Reimbursement levels for drugs and medical devices are recommended by the Central Social Insurance Medical Council (Chuikyo), and enacted based on that recommendation by the Minister of Health, Labor and Welfare. Chuikyo is a consultative council made up of representatives of the government (7), the medical profession (7), the public (6), and various other specializations (10). Prices for all drugs and devices are reviewed and adjusted every two years, while the procedure for an initial price for a newly marketed drug is separate. Chuikyo tends to reduce the costs of existing drugs in an attempt to Copyright © 2017 Pacific Bridge Medical. Innovator products usually see cuts of 1% or less, while generics face heavier price reductions. Products with orphan designation are eligible for a 10% premium in calculating a price. However, this only applies if the orphan indication is the primary indication for which the drug is approved. In addition, there are other, higher premium categories which orphan drugs may often fall into. There are no existing drugs with similar indications the exact premium category depends on how many of these items are fulfilled. This is especially true when determining the number of Japanese clinical trials required for approval. The drug company may also want to begin the search for appropriate distributor candidates that may be interested in marketing the product in Japan. Keep in mind that either the company or the distributor may file the new drug application dossier. If the drug company does not have its own office in Japan, it will also need to select a Marketing Authorization Holder, which will be responsible for quality and post marketing safety of the product in Japan. Japanese Society for Inherited Metabolic Diseases Address: 3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan 105-0003 Phone: +81-96-373-5191 Fax: +81-96-366-3471 Email: jsimd@jikei.

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This child showed prolonged and severe (or, less often, cyanosis or facial blushing), mydriasis (or, autonomic symptoms (nausea, vomiting, pallor, brady less often, miosis), coughing, hypersalivation, urinary cardia) that are mainly due to acute cerebral insults, but and fecal incontinence, and cardiorespiratory and ther can also be diagnosed as status migrainosus or auto 3 moregulatory alterations. During seizure evolu identify shorter but similar episodes, suggesting that the tion, the child can become flaccid and unresponsive in two latter hypotheses are most likely correct. Migraine 20% of cases (ictal syncope), with tonic eye and head and epilepsy are highly comorbid conditions that may deviation. Headache is often concurrent with other au share the same pathophysiology, but the nature of their tonomic symptoms. Our case does not fulfill the diag oropharyngolaryngeal movements, and behavioral dis nostic criteria for migraine with aura of the Interna turbances occur less frequently. The aura, which can be visual, sensory, or 4 nearly half of cases (autonomic status epilepticus). Usually, autonomic manifestations are could be related to a basilar-type migraine rather than to an generated by activation or inhibition of parts of the cen aura. Differential diagnosis between seizure and migraine tral autonomic network that involves the insular cortex, could be complicated by the presence of headache in both. Therefore, ictal discharges may easily ing or within 1 hour of a typical migraine aura attack activate the lower threshold autonomic centers. Antiepileptic therapy was started Conversely, there are very few cases of ictal cardiorespi (valproic acid, 20 mg/kg/day). Children have normal physical known by practitioners in clinical emergency medicine. Al rectal, or buccal preparations, are commonly used to though more studies are needed on the subject, terminate autonomic status epilepticus. Autonomic seizures and autonomic in our patient, valproic acid therapy was started and status epilepticus peculiar to childhood: diagnosis and symptoms resolved completely. Panayiotopoulos symptoms and signs may occur as epileptic seizure man syndrome: a consensus view. Ictal cardiorespira diagnosis can be easily missed and have potentially life 9 tory arrest in Panayiotopoulos syndrome. Panayiotopoulos syndrome: a benign child hood autonomic epilepsy frequently imitating encephali that can be very alarming. Neurology 72 April 14, 2009 20e717 M anagem ent dilem as Despite the ever-increasing number of randomized any other neurologic subspecialty, yet significant con controlled trials for treatment of neurologic diseases, troversy persists over how to interpret these data. In individual patients present unique clinical dilemmas, the cases in this section, the authors describe the man and it can be challenging to determine how best to agement of patients with cerebrovascular disease, apply the findings from large studies in individual exploring both how existing data can be used to guide cases. In the field of vascular neurology, for example, complex clinical reasoning and the limitations of ex clinical trial data are perhaps more extensive than in isting data when applied to individual patients. What is the localization and differential diagnosis Correspondence to pronator drift. In a series of the differential diagnosis for acute-onset neurologic 1,008 patients age 15–49 with first stroke, cardioemb deficits includes vascular causes, seizures, and migrain olism and cervical artery dissection were the 2 most ous phenomena. On further question eye, but no extraocular muscle weakness was detected ing, there were no identifiable inciting events for the on examination. How should the patient’s carotid dissection be or hypoperfusion due to pathology of the internal managed? The most recent meta-analysis of dissection and until more definitive data are available, it is nonrandomized data included 1,636 patients from 39 reasonable to consider anticoagulation in such patients,5 studies in which 1,137 patients were anticoagulated though this decision must be individualized, weighing (with unfractionated heparin, low-molecular-weight the risks of intracranial hemorrhage, especially in cases heparin, or warfarin) and 499 received antiplatelet of large stroke or intradural extension of dissection. There Approximately 24 hours after his presentation and were no statistically significant differences in rates of 12 hours after initiation of anticoagulation, he devel stroke or mortality between the 2 treatment strategies. His However, it has been noted that most studies of carotid blood pressure was 100/60 mm Hg. In our patient, radiologic evidence of carotid occlu uted to hypotension, there is evidence that embolism sion and a blood pressure of 100/60 mm Hg suggested may also play a role. The end-arterial territories are hypoperfusion as the mechanism of his new strokes. How can ongoing cerebral ischemia attributable to cranial Doppler high-intensity transient signal studies. However, because our hypertension included only 13 patients,7 and the larg patient had new strokes while receiving anticoagulation est retrospective study only 46 treated patients. At sys methodology, duration of induced hypertension, tolic blood pressures of 130 mm Hg and above, he was and concurrent use of anticoagulation with induced able to maintain his right arm against gravity, but below hypertension. However, several important observations this threshold, he could not lift this arm from the bed. Patients with acute ischemic His aphasia persisted even at systolic blood pressure of stroke most likely to benefit from induced hypertension 180. This blood pressure threshold for his right arm are those with large-vessel occlusion or stenosis. He was discharged to rehabilitation sure above which a neurologic deficit is reversed and on warfarin, midodrine, and fludrocortisone. There appears to up 1 month later, he had full right arm strength, and be no increased incidence of hemorrhagic complications his aphasia had begun to improve. Midodrine and fludro or other adverse outcomes in patients undergoing cortisone were tapered without recurrence of symptoms. Should the patient undergo repeat imaging to aid both safe and beneficial in selected patients. This will duration of 6 months is based in part on the largest hopefully yield answers to long-controversial questions study of stroke recurrence after cervical artery dissection in the management of cervical artery dissection. Berkowitz conceived of, wrote, and revised the manuscript; created the fig were 4 recurrent strokes: 2 within the first 6 months of ure; and cared for the patient. Voinescu revised the manuscript and cared follow-up in patients with incompletely healed dissec for the patient. Berkowitz reports no relevant disclosures, but receives royalties from Clinical remains occluded, and continuation of anticoagulation Pathophysiology Made Ridiculously Simple (Medmaster, Inc. Stroke 2009;40: our decision to discontinue anticoagulation and initiate 1195–1203. Time course of symptoms in extracranial artery internal carotid artery, anticoagulation was discontin dissections: a series of 80 patients. Impaired clearance of emboli 1 (washout) is an important link between hypoperfusion, causeofstrokeintheyoung. Arch Neurol 1998;55: include trauma, chiropractic manipulation, and connec 1475–1482. Up to 43% of patients with cervical artery dis prevention of stroke in patients with stroke or transient section presenting with local symptoms alone may ischemic attack: a guideline for healthcare professionals ultimately have strokes,4 so discovery of dissection war from the American Heart Association/American Stroke rants stroke preventative therapy, even if initial symp Association. Risk of stroke and recurrent dissection after a cervical artery dissection: a mul randomized controlled trials to guide therapeutic ticenter study. Cranial nerve palsies in spon antiplatelet agents or anticoagulants, optimal duration of taneous carotid artery dissection. J Neurol Neurosurg Psy therapy, and when or if to repeat cervical arterial imaging chiatry 1993;56:1191–1199. Medica Question for consideration: tions included combined estrogen-progestin oral contra ceptives. What is the localization and differential diagnosis Correspondence to but arousable, groaning incoherently, and unable to of the examination findings? There was no history of trauma suggestive Decreased spontaneous movement of the right side of intracranial injury, progressive localizing neurologic could point to a left-sided lesion, although localiza deficits indicating an expanding mass lesion, fever tion can be challenging in the setting of herniation. How should the venous sinus thrombosis be sinuses with significant dilation of cortical veins.

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