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Biomedical subjects

R Pop

Publications and source records attributed to R Pop.

At least 37 records · Page 2Linked to original sources
PubMedDate not supplied

Dissolution and in vivo evidence of differences in reference products: impact on development of generic drugs.

The WHO List of International Comparator Pharmaceutical Products (CPP) For Equivalence Assessment of Interchangeable Multi-Source (Generic) Products will address an important issue in developing new generic drugs because it will identify the 'correct' reference product. This list will reduce unnecessary clinical studies in jurisdictions requiring new generics to be compared with brand products sold locally. Eventually, by employing the CPP, there will be a world-wide standard for brand and generic drugs, assuring the same level of quality internationally. The strategy of a single global reference is meritorious, but there are several hurdles to overcome. Most important is that the same brand may differ in dissolution and/or bioavailability in various jurisdictions, including some drugs with a narrow therapeutic index like phenytoin. Several examples are provided in this manuscript. This issue of regional differences has relevance, not only to the WHO list, but also to the matter of how safety and efficacy was established for that product in the first place. Normally, phase III clinical studies are conducted on a product manufactured in a single site, set to one standard. If the product differs in bioavailability in different jurisdictions, one is left with the question: 'which product has remained true to the original formulation?' Alternatively, if safety and efficacy is maintained with all formulations, then one is faced with the question: 'are the criteria currently employed for bioequivalence unnecessarily restrictive?'

Drug Industry↗
PubMedDate not supplied

[37 tumors of the jejuno-ileum].

The present paper reports on 37 primary tumours of the jejunoileum, of which 19 malignant and 18 benign. The authors emphasize the difficulty of establishing a diagnosis before the onset of one of the dramatic complications in the evolution of tumours of the small intestine. The patients were admitted for the following complications: occlusive syndrome -- 28 cases (72.9%), peritoneal syndrome -- 6 cases (16.2%) and hemorrhagic syndrome -- 3 cases (8.1%). All the patients with a peritoneal and hemorrhagic syndrome had malignant tumours.

Adult↗
PubMedDate not supplied

[Late hemorrhage after traumatic rupture of the spleen].

A study was performed of 31 late hemorrhages following traumatic rupture of the spleen. The authors make some considerations in connection with problems of diagnosis and treatment. The difficulty is stressed, encountered in the diagnosis of splenic rupture immediately after the causative trauma, and the high death-rate that ensues. In view of impriving the present results by early surgical treatment, the utility is stressed of clinical observation, as well as of hematologic, radiologic and angiographic explorations of these patients.

Adult↗
PubMedDate not supplied

[Clinico-statistical observations on malignant ocular tumors surgically resolved at the Cluj-Napoca Ophthalmological Clinic between 1970 and 1990].

During the period mentioned above there ware hospitalized 54 patients having epibulbar tumours. The anatomopathological exam which was effectuated for 33 patients hes shown Bowen's disease for 14 cases, spinocellular carcinoma for 15 patients and basocellular for 3 patients. There were 4 cases for epibulbar precancerous. There was retinoblastoma for 19 cases; it had been practiced the enucleation of ocular globe for 17 patients and for two cases it had been practiced the exenteration of the eye socket. At the same period there were 91 uveal melanosis 6 of which having iridial localization, 10 cases of ciliary body [correction of cylar corpus], 75 cases of choroid. The hepatic scintigraphy was practiced for 56 patients and had shown for 8 cases hepatic metastasis. The histopathological exam of the melanomata of ciliary and choroidal corpus had shown type A fusiform cells for 22 cases, type B for 43 cases, epithelioid cells for 6 cases and mixed type cells for 13 cases. The hepatic metastasis were epithelioid cells for all the cases and, for 2 cases there were with mixed type cells, It is necessary an active discovering of intraocular and episcleral malign tumours, for increasing the chance of an earlier diagnosis during a stadium that would be able to be treated as conservator as possible be.

Eye Neoplasms↗
PubMedDate not supplied

[The serology of toxoplasmosis in uveitis].

Determinations for decelerating the antitoxoplasma anticorps that have been effectuated for 696 uveas proved positivity at 123 aerums (17.6%). The repartition of the positive serology concerning the clinic form of the uvea has proved 48 iridocyclitis, 26 serous central corioretinals, 23 in panuveitis, 13 in posterior uveitis, 11 muscular chorioretinitis, 2 in hyalitis. Taking into consideration only the equal or less than 1:160 titrures, these have been at 7 iridocyclitis, 4 serous central chorioretinitis, 4 panuveitis, 3 posterior uveitis and 3 atrophic central chorioretinitis. It is shown that the diagnosis of ocular toxoplasma must be effectuated just corroborating the clinic data with the positive serology. The antiparasitic treatment doesn't influence upon the low titrures of serous anticorps, which generally maintain at the same value all the life.

Animals↗
PubMedDate not supplied

[Spontaneous luxation of the crystalline lens into the anterior chamber (a clinical case report)].

A patient of 45 years old presents a sprained crystal in the anterior chamber, with secondary acute glaucoma at the left eye and surgically aphakia with ciliary staphyloma and optic atrophia for the right eye. VOR zero; VOL-PL; TOR-17,3 mm Hg; TOL-81, 9 mm Hg. After hypotension of the eye using a perfusion of mannitol and acetazolamide the ocular tension is normalized. It is practiced the extraction of the lens from the anterior chamber with a good post-surgically evolution. The disease may be joined to Marfan, Marchesani, syndrome homocystinuria or an early diagnosis of the zone without any manifest cause.

Anterior Chamber↗
PubMedDate not supplied

[Echographic differential diagnosis in oculo-orbital tumors].

Within the period October 1987-September 1990, the authors submit 130 patients to clinical examination and ultrasonography the latter performed by adapting commercially available ultrasonograph type Bruel and Kjaer 3405 and Shimasonic. Among the investigated individuals, 25 exhibited oculo-orbital tumours of various types. The cases are assessed considering the following for establishing the diagnosis: clinical examination, ultrasonography, fluorescein angiography, radiotracer and morphopathological examinations. Besides the use an adapted device, the authors propose a simple and fast morphopathological method: the fixation in formaldehyde solution as long as 48 hours.

Diagnosis, Differential↗
PubMedDate not supplied

[Rare palpebral tumors in children].

The paper reports on two cases of rare palpebral tumours--pilomatrixomas--existent in two children under the age of two years.

Eyelid Neoplasms↗