Ondansetron hydrochloride, a 5 HT3 antagonist is a powerful antiemetic drug which has oral bioavailability of 60% due to hepatic first pass metabolism and has a short half-life of 5 h. To overcome the above draw back, the present study was carried out to formulate and evaluate fast dissolving films of ondansetron hydrochloride for sublingual administration. The films were prepared from polymers such as polyvinylalcohol, polyvinyl pyrrolidone, Carbopol 934P in different ratios by solvent casting method. Propylene glycol or PEG 400 as plasticizers and mannitol or sodium saccharin as sweeteners were also included. The IR spectral studies showed no interaction between drug and polymer or with other additives. Satisfactory results were obtained when subjected to physico-chemical tests such as uniformity of weight, thickness, surface pH, folding endurance, uniformity of drug content, swelling index, bioadhesive strength, and tensile strength. Films were also subjected to in vitro drug release studies by using USP dissolution apparatus. Ex vivo drug permeation studies were carried out using porcine membrane model. In vitro release studies indicated 81-96% release within 7 min and 66-80% within 7 min during ex vivo studies. Drug permeation of 66-77% was observed through porcine mucosa within 40 min. Higher percentage of drug release was observed from films containing the sweeteners. The stability studies conducted for a period of 8 weeks showed no appreciable change in drug content, surface pH, and in vitro drug release.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub] [CITATIONS]  [PubMed]

The present work was aimed at formulation development, evaluation and comparative study of the effects of superdisintegrants in Cefixime 50 mg oral disintegrating tablets. The superdisintegrants used for the present study were sodium starch glycolate and crosscarmellose sodium. The formulated tablets were evaluated for various tableting properties, like hardness, thickness, friability, weight variation, disintegration time and dissolution rate. Comparative evaluation of the above-mentioned parameters established the superiority of the tablets formulated with crosscarmellose sodium to those formulated with sodium starch glycolate.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

The synthesized benzimidazoles compounds were prepared from the condensation reaction between o-Phenylenediamine and various carbonyl compounds, in the presence of ammonium chloride as a catalyst. Ammonium chloride is a commercial and environmentally benign catalyst. The yield of all benzimidazole derivatives was found to be in the range of 75 - 94%. The purity of the compounds was ascertained by melting point and TLC. The synthesized compounds were characterized by using IR, ¹ H NMR, and MASS spectral data together with elemental analysis. The synthesized benzimidazole compounds were screened for acute and chronic anti-anxiety activity in Wistar rats by using an elevated plus maze model with standard Diazepam. The synthesized compounds Z _B , Z _E , Z _F , Z _G , and Z _H showed potent anti-anxiety activity when compared to the standard Diazepam. The compound Z _H exhibited a higher anti-anxiety activity when compared to other prepared benzimidazoles. The results were subjected to statistical analysis by using one-way ANOVA followed by the Tukey-Kramer test, to calculate the significance.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

The aim of this study was to prepare zopiclone-loaded polycaprolactone microspheres by emulsion solvent evaporation technique with different drug-to-carrier ratios {MP 1 (1:1), MP 2 (1:2), MP 3 (1:3), and MP 4 (1:4)}, characterize and evaluate the in vivo performance. The microspheres were characterized for particle size, surface morphology, drug excipient compatibility, percentage yield, drug entrapment, and in vitro release kinetics. Pharmacokinetics and pharmacodynamics were evaluated after parenteral administration so as to determine the sustained action of the drug after one-time administration of the formulation in a rat model. Of four formulations prepared, MP 2, i.e., 1:2 (drug-polymer) ratio was selected as the optimized formulation based on particle size, particle shape, and the release behavior. The size of microspheres was found to be ranging from 5.4 to 12.1 μm. The shape of microspheres was found to be spherical by SEM. Among the four formulations, MP 2 (1:2) showed maximum percentage yield of 75% ± 2.68%. There was no interaction between drug and polymer by FT-IR study. In the in vitro release study, formulation MP 2 (1:2) showed 86.5% drug release and was found to be sustained for 10 days. The microsphere formulations were able to sustain the release of drug both in vitro and in vivo. Pharmacodynamic study (Maze apparatus) indicated that the anxiolytic activity shown by zopiclone microspheres was significant when compared to the zopiclone solution given daily.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

[FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Three simple and sensitive visible spectrophotometric methods (A, B, and C) have been developed for the quantitative estimation of mesalamine in bulk drug and pharmaceutical dosage forms. Methods were based on the formation of colored chromogens, which were measured at 552 nm, 440 nm, and 494 nm, respectively. The results obtained with the proposed methods were found to be unsatisfactory with the labeled amounts when the tablet dosage forms were analyzed.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

After a drug is confirmed as safe and efficacious in preclinical studies, it is tested in healthy human volunteers for first in man trials. In 2006, a phase I clinical study was conducted for a CD28 superagonist antibody TGN1412 in six human volunteers. After very first infusion of a dose 500 times smaller than that found safe in animal studies, all six human volunteers faced life-threatening conditions involving multiorgan failure for which they were moved to intensive care unit. After this particular incident, a lot was changed over how first in man trials are approved by regulatory authorities and the way clinical trials are conducted. This review primarily deals with preclinical studies conducted by TeGenero, results of which encouraged them to test the antibody on human subjects, reasons why this drug failed in human trial and aftermath of this drug trial. In addition, another drug-Fialuridine which failed in phase 2 clinical trial leading to death of five human subjects is briefly reviewed.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

The matrix tablets of diltiazem hydrochloride were prepared by direct compression using hydroxypropyl methyl cellulose (HPMC) and various amounts (2.5%, 5.0%, 10% and 20%) of citric acid, malic acid and succinic acid. The characterization of physical mixture of drug and organic acids was performed by Infra-red spectroscopy. An organic acid was incorporated to set up a system bringing about gradual release of this drug. The influence of organic acids on the release rate were described by the Peppas equation: M _t /M_∞ = Kt ⁿ and Higuchi's equation: Q _t = K ₁ t ^1/2 . The addition of organic acids and the pH value of medium could notably influence the dissolution behavior and mechanism of drug-release from matrices. Increasing amounts of organic acid produced an increase in drug release rate, which showed a good linear relationship between contents of organic acid and drug accumulate release (%) in phosphate buffer, pH 7.4. The drug release increased significantly (P < 0.05) with use of succinic acid in tablet formulation. Increasing amounts of succinic acid above 10% produced decreasing values of n and increasing values of k, in a linear relationship, which indicated there was a burst release of drug from the matrix. Optimized formulations are found to be stable upon 3-month study.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

The study was aimed at assessing the magnitude and factors of self-medication among medical, pharmacy, and health science students of GCMHS (Gondar College of Medicine and Health Sciences). A cross-sectional study with two-month illness recall was conducted. A Questionnaire consisting of demographic questions and questions on illnesses in the last two months prior to the interview and treatment strategies was prepared and administered to the 414 students, selected as the sample population, from the GCMHS students. Of a total of 414 students, 213 (51.5%) reported at least one episode of an illness, and 82 (38.5%) of them practiced self-medication. Most drugs for self-medication were obtained from the pharmacy or drug shops; and the most commonly used drugs were Paracetamol and NSAIDs (Non-steroidal anti-inflammatory drugs). Common reported illnesses were fever and headache (24.8%) followed by cough and common cold (23.9%). Prior experience and the non-seriousness of the illness were the top two reported factors for self-medication. Reading materials were the top reported source of information. In conclusion, self-medication was practiced with a range of drugs from the conventional anti-pains to antibiotics. Although the practice of self-medication is inevitable; drug authorities and health professionals need to educate students about the pros and cons of self-medication.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

The topic of drug-drug interactions has received a great deal of recent attention from the regulatory, scientific, and health care communities worldwide. Nonsteroidal anti-inflammatory drugs, antibiotics and, in particular, rifampin are common precipitant drugs prescribed in primary care practice. Drugs with a narrow therapeutic range or low therapeutic index are more likely to be the objects for serious drug interactions. Object drugs in common use include warfarin, fluoroquinolones, antiepileptic drugs, oral contraceptives, cisapride, and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors. The pharmacist, along with the prescriber has a duty to ensure that patients are aware of the risk of side effects and a suitable course of action should they occur. With their detailed knowledge of medicine, pharmacists have the ability to relate unexpected symptoms experienced by patients to possible adverse effects of their drug therapy.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

A simple, fast, specific, and precise high-performance thin layer chromatography method has been developed for the estimation of monosodium l-glutamate (MSG) in food products. Aluminum plates precoated with silica gel 60 GF ₂₅₄ were used as stationary phase and a mixture of methanol-chloroform-formic acid in the ratio 5:5:1 (v/v) as mobile phase. Quantification was carried out by postchromatographic derivatization using 1% ninhydrin solution, and the developed spots were scanned by using a densitometer in absorbance mode at 485 nM. The R _f value of MSG was 0.64. The results of the analysis have been validated statistically and by the recovery studies. Linearity was observed in the concentration range of 400-1000 nG.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]

Ondansetron hydrochloride is an intensely bitter antiemetic drug used to treat nausea and vomiting following chemotherapy. The purpose of the present work was to mask the taste of ondansetron hydrochloride and to formulate its patient-friendly dosage form. Complexation technique using indion 234 (polycyclic potassium with carboxylic functionality) and an ion-exchange resin was used to mask the bitter taste and then the taste-masked drug was formulated into an orodispersible tablet (ODT). The drug loading onto the ion-exchange resin was optimized for mixing time, activation, effect of pH, mode of mixing, ratio of drug to resin and temperature. The resinate was evaluated for taste masking and characterized by X-ray diffraction study and infrared spectroscopy. ODTs were formulated using the drug-resin complex. The developed tablets were evaluated for hardness, friability, drug content, weight variation, content uniformity, friability, water absorption ratio, in vitro and in vivo disintegration time and in vitro drug release. The tablets disintegrated in vitro and in vivo within 24 and 27 s, respectively. Drug release from the tablet was completed within 2 min. The obtained results revealed that ondansetron HCl has been successfully taste masked and formulated into an ODT as a suitable alternative to the conventional tablets.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Stephania hernandifolia (Menispermaceae) is a medicinal plant, used by herbalists for treating various diseases, one of which is diabetes mellitus, in Darjeeling. However, its antidiabetic activity has not been scientifically investigated so far. The aim of this study, therefore, is to investigate the antidiabetic and antioxidant potential of the powdered corm of Stephania hernandifolia. This was tested in normal and Streptozotocin (STZ)-induced diabetic rats, using oral administration of ethanol and an aqueous extract (400 mg/kg body weight) of Stephania hernandifolia corm. After the oral administration of water and ethanol extracts at doses of 400 mg/kg body weight, blood glucose levels were monitored at specific intervals and it was found that they were significant lowered. Glibenclamide was used as a standard drug at a dose of 0.25 mg/kg. The experimental data revealed that both extracts has significant antihyperglycemic and antioxidant activity in Streptozotocin-induced rats compared to the standard drug. The antioxidant activity in vitro was measured by means of the 1, 1-diphenyl-2-picrylhydrazyl (DPPH) and Superoxide-free radical scavenging assay. Ascorbic acid, a natural antioxidant, was used as a control. The extracts of ethanol and aqueous were strongly scavenged DPPH radicals, with IC ₅₀ being 265.33 and 217.90 μg/ml, respectively. Although the extracts of ethanol and aqueous were moderately scavenged, the superoxide radical were with IC ₅₀ values of 526.87 and 440.89 μg/ml. The study revealed that the ethanolic extract exhibited more significant antidiabetic and antioxidant activity then the aqueous extract.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub] [CITATIONS]  [PubMed]

A total of 856 diabetic patients were evaluated for pharmacotherapy-based problems like for possible drug interactions, adverse drug reactions, and other mismatches, if any. Poor correlation between the advised insulin therapy and patients' fasting blood glucose levels (12%, n=103) was observed. To most of the patients (41.66%, n= 357), insulin therapy was advised in combination with glucocorticoides, thiazides diuretics, and propranolol. Prescribing beta blocker (propranolol) with insulin is contraindicated. The higher incidence of diabetic foot patients was in the mean age of 57±3.4 years that was controlled with combination therapy of insulin and oral antidiabetics (63.0%, n=516). 11.1% of the treated patients could not take the prescribed therapy due to poor acceptance of insulin therapy due to its syringe needle prick. 41.66% risks of potential drug interactions, 7.93% adverse drug reactions, and 6.6% mismatches were recorded, as per the international approved algorithm, for managing a diabetes mellitus that reflects poor health care system. All these events necessitate for coordinating with other health professionals to make the therapy safer in the better interest of the patients. It is concluded that in practice prescribing pattern carries more risks for patients. It is imperative to improve the practice of pharmacotherapeutics rather than to practice in routine.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Two methods are described for determination of Doxophylline in a solid dosage form. The first method was based on ultraviolet (UV)-spectrophotometric determination of the drug. It involves absorbance measurement at 274 nm (λ_max of Doxophylline) in 0.1 N hydrochloric acid. The calibration curve was linear, with the correlation coefficient between 0.99 and 1.0 over a concentration range of 0.20-30 mg/ml for the drug. The second method was based on high-performance liquid chromatography (HPLC) separation of the drug in reverse-phase mode using the Hypersil ODS C ₁₈ column (250 X 4.6 mm, 5 mm). The mobile phase constituted of buffer acetonitrile (80:20) and pH adjusted to 3.0, with dilute orthophosphoric acid delivered at a flow rate 1.0 ml/min. Detection was performed at 210 nm. Separation was completed within 7 min. The calibration curve was linear, with the correlation coefficient between 0.99 and 1.0 over a concentration range of 0.165-30 mg/ml for the drug. The relative standard deviation was found to be <2.0% for the UV-spectrophotometry and HPLC methods. Both these methods have been successively applied to the solid dosage pharmaceutical formulation, and were fully validated according to ICH guidelines.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Significant depletion of glutathione (GSH-reduced form) was observed in type 2 diabetes due to oxidative stress. Hence the present study was aimed to investigate a drug which restores GSH along with its anti-diabetic activity. Aqueous extract of Garcinia indica at a dose of 100 mg/kg and 200 mg/kg was given orally to streptozotocin-induced type 2 diabetic rats for a period of 4 weeks. At the end, parameters such as fasting blood glucose, postprandial blood glucose, and GSH in blood were analyzed. Aqueous extract of G. indica significantly decreased both the fasting and postprandial blood glucose in type 2 diabetic rats. The extract also restored the erythrocyte GSH in type 2 diabetic rats. Drug at higher dose, i.e. 200 mg/kg, had a more pronounced effect. Restoring the erythrocyte GSH, an intracellular anti-oxidant in diabetes, will be beneficial specially by preventing the risk of developing complications.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Aim: Citrus aurantifolia (Family Rutaceae) is commonly known as a familiar food and medicine, and s therapeutic effectiveness in a variety of diseases has been suggested in traditional medicine. Various complementary and alternative medicines (CAM) have been shown to interact with orthodox medicines. Hence, the aim of this study is to investigate such a phenomenon particularly the interaction of lime fruit juice with warfarin. Materials and Method: Wistar strain albino rats of both sexes weighing between 190 and 230g were administered with oral doses of the respective drugs used depending on the groups of animals. Effects on the anticoagulant activity of warfarin were determined by standard laboratory methods. Result: Lime fruit juice caused a reduction in the anticoagulant activity of warfarin. Conclusion: This finding has shown that CAM can interact with orthodox medicines hence, warfarin prescribers need to be aware of the usage of CAM and monitor the international normalized ratio (INR) of their patients more frequently.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Ondansetron is a serotonin 5HT3 antagonist; anti-emetic drug. Bitter taste of the ondansetron is a major problem in ensuring patient compliance. The study was designed to formulate tasteless complexes of ondansetron with ion exchange resin and evaluate molecular properties of drug complex. The drug-loading process was carried out using various resins and was optimized using different drug:resin ratio and pH. Resinates were characterized by infrared spectroscopy, thermal analysis, and X-ray powder diffraction (XRPD). Indion 234 gave the best loading efficiency at drug resin ratio of 1:1.5. pH had no effect on drug loading. XRPD studies revealed that drug is in amorphous state in complex. The Infrared studies revealed complexation of secondary amine group of drug with carboxylic functional group of resin. Taste evaluation by using semiquantitative method found resonates as tasteless and agreeable. The release of drug from resinates in simulated gastric fluid was complete in 30 min. Thus, ion exchange resinates offer an effective tool for masking of bitterness and improve drug release.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Objective: To study the possible effects of methanolic extract of fruits of Tamarindus indica on rabbit's jejunum preparations. Materials and Methods: The study was carried out on rabbit's jejunum preparations. Methanolic extract of fruits of T. indica was applied in different doses. Potassium chloride (KCl 80 mM)-induced contractions were relaxed by the extract. For determination of possible mode of action of relaxing effects, calcium chloride curves were constructed in decalcified tissues using K ⁺ normal and followed by K ⁺ rich solution. The curves were then compared with verapamil. Results: Relaxant effects on KCl-induced contractions were prominent at a concentration of 5.0-10.0 mg/ml (P<0.05). A right shift at a concentration of 3.0 mg/ml (EC ₅₀ ± SEM = 1.98 ± 0.03) and 10.0 mg/ml (EC ₅₀ ± SEM = 1.79 ± 0.05) versus control (EC ₅₀ ± SEM = 2.33 ± 0.058) resembled the effects of verapamil on the calcium chloride curves. Conclusion: The results confirmed its possible mode of relaxing effects i.e. through calcium channel blockade.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

[FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

The objective of the study was to develop a high performance liquid chromatography (HPLC) method using ultra violet (UV) detection for the determination of flavoxate HCl in bulk and solid dosage forms by using ibuprofen as the internal standard. Eclipse C18 column (150 mm x 4.6 mm, 5 μm) was used as the stationary phase with a mixture of acetonitrile : 0.1% formic acid in water (75: 25 v/v) as the mobile phase. The response of the drug was linear in the concentration range of 1 - 250 μg/ml. Limit of detection and Limit of quantification were found to be 0.23 μg/ml and 0.69 μg/ml, respectively. The percentage of recovery ranged between 97.4 and 101.3%. The factors affecting column separation of the analyte were studied. The results demonstrated that this method is reliable, reproducible, and suitable for routine quantitative use.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Luffa echinata Roxb., commonly known as Bindal in Hindi is used for its hypoglycemic activity in the indigenous system of medicine. No pharmacognostical study on stem is reported in the literature till date; therefore, it was decided to study macroscopical and cytomorphological characters in detail to bring out salient diagnostic features. The stem pieces available in the market are 1.5-17 cm long and 5-8 mm in diameter, showing yellowish-brown to brownish-black surface with longitudinal furrows, fracture is fibrous, and taste is bitter. Mature stem shows single-layered epidermis, seven layers of collenchyma below five ridges but one to two layers of parenchyma in rest of the region beneath the epidermis, continuous wide wavy layer of pericycle composed of three to eight layers of fiber. There are five conjoint bi-collateral open vascular bundles one below each ridge and additional four medullary vascular bundles in the pith each facing furrows.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

Objective: In the last 30 years, concepts in pharmacology have moved from Essential Medicines (EM) to P-drugs via the Rational Use of Medicines (RUM), but no structured study has evaluated the level of understanding among working clinicians about these concepts. The present study is designed to fulfill that lacuna. Materials and Methods: A cross-sectional study was carried out in and around the teaching hospitals attached to Medical Colleges, enrolling 504 clinicians from six centers across North India to fill-up a questionnaire containing 25 questions. The results were compiled using percentages and averages. Results: Only one-fourth of the participants claimed that they always prescribed Essential Medicines; no one could accurately count the number of drugs / drug combinations in the Indian Essential Drug list; only 15.1% of the clinicians used to write the generic names of drugs on a prescription slip; about one-third of the clinicians were not fully aware about the adverse effects, drug interactions, and contraindications of the drugs they prescribed; about 83% of the physicians admitted to rely on information from Medical Representatives (MRs) and the interest in research activities seemed to be lost. Conclusion: Results show a sorry state of affairs among clinicians, as far as the level of understanding about EM, P-drugs, and RUM is concerned, and points toward arranging more continuing medical education (CME) for clinicians regarding these concepts.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]

'Medical Devices' include everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Regulations embody the public expectations for how buildings and facilities are expected to perform and as such represent public policy. Regulators, who develop and enforce regulations, are empowered to act in the public's interest to set this policy and are ultimately responsible to the public in this regard. Standardization contributes to the basic infrastructure that underpins society including health and environment, while promoting sustainability and good regulatory practice. The international organizations that produce International Standards are the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU). With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring that imports meet the internationally recognized levels of performance and safety. The development of standards is done in response to sectors and stakeholders that express a clearly established need for them. An industry sector or other stakeholder group typically communicates its requirement for standards to one of the national members. To be accepted for development, a proposed work item must receive a majority support of the participating members, who verify the global relevance of the proposed item. The regulatory authority (RA) should provide a method for the recognition of international voluntary standards and for public notification of such recognition. The process of recognition may vary from country to country. Recognition may occur by periodic publication of lists of standards that a regulatory authority has found will meet the Essential Principles. In conclusion, International standards, such as, basic standards, group standards, and product standards, are a tool for harmonizing regulatory processes, to assure the safety, quality, and performance of medical devices. Standards represent the opinion of experts from all interested parties, including industry, regulators, users, and others.

[ABSTRACT]  [FULL TEXT]  [PDF]  [Mobile Full text]  [EPub]  [PubMed]