International Conference on Harmonization-stability

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DEVELOPMENT OF A NEW STABILITY INDICATING RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF EPALRESTAT AND PREGABALIN AND ITS VALIDATION AS PER INTERNATIONAL CONFERENCE ON HARMONIZATION GUIDELINES

DEVELOPMENT OF A NEW STABILITY INDICATING RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF EPALRESTAT AND PREGABALIN AND ITS VALIDATION AS PER INTERNATIONAL CONFERENCE ON HARMONIZATION GUIDELINES

defined as a rise in urinary albumin excretion rate, often associated with an increase in blood pressure, but without evidence of other causes of renal disease [8]. Literature survey revealed that reversed-phase high-performance liquid chromatography (RP-HPLC) [9-14] has been reported for the estimation of epalrestat and pregabalin. The method was optimised by ammonium acetate buffer and acetonitrile for the simultaneous estimation of epalrestat and pregabalin [10]. The patients with diabetic nephropathy were divided into groups and multicentered study was conducted by epalrestst and methylcobalamine [9]. The gradient programme was used for chromatographic seperation using mobile phase as potassium dihydrogen phosphate and acetonitrile. The method was developed by phosphate buffer and acetonitrile with pH 6.9 using photodiode array detector[11]. Pregabalin was determined using precolumn derivatisation technique with uv detector using human plasma [12]. For the determination of pregabalin RP-HPLC method was developed using isocratic mode for chromatographic seperation followed by stability studies [13]. simultaneous determination of pregabalin and methylcobalamin was succesfully analyzed in bulk drug and marketed formulation using RP-HPLC method [14]. A stability indicating method accurately measures the active ingredient without the interference from degradation products, process impurities [15]. According to International Conference on Harmonization (ICH) guideline [16], the guidelines explicitly require the conduct of forced degradation studies under a variety of conditions such as PH, light, oxidation, and dry heat and separation of drug from degradation products [17]. To the best of our knowledge, only one stability indicating RP-HPLC method has been © 2018 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ajpcr.2018.v11i5.22256

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INTERNATIONAL CONFERENCE ON HARMONIZATION RECOMMENDED FORCED DEGRADATION STUDIES AND DEVELOPMENT OF A NEW VALIDATED ISOCRATIC REVERSE PHASE ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF TELMISARTAN AND AMLODIPINE I

INTERNATIONAL CONFERENCE ON HARMONIZATION RECOMMENDED FORCED DEGRADATION STUDIES AND DEVELOPMENT OF A NEW VALIDATED ISOCRATIC REVERSE PHASE ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF TELMISARTAN AND AMLODIPINE I

(R2) [9] suggests that stress studies should be carried out, leading to the identification of likely degradation products. For stability samples, it also requires that analytical test procedures should be stability indicating and they should be fully validated. The literature survey revealed that several analytical methods have been reported for the quantitative estimation of TEL alone and in combination with other drugs. Several reverse-phase high-performance liquid chromatography (RP-HPLC), high-performance thin-layer chromatography methods [10-19], ultraviolet (UV) spectroscopy method [20-23] were reported for estimation of TEL and AMD, but very few research papers have reported their degradation profile [24-27]. However, in the reported methods we found some drawbacks which are listed below.

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Development and Validation of a RP-HPLC Method for Simultaneous Estimation of Antitubercular Drugs in Solid Lipid Nanoparticles

Development and Validation of a RP-HPLC Method for Simultaneous Estimation of Antitubercular Drugs in Solid Lipid Nanoparticles

A new simple, rapid and sensitive reversed-phase high-performance liquid chromatography method was developed and validated as per International Conference on Harmonization guidelines, Q2 (R1), for simultaneous estimation of isoniazid, pyrazinamide and rifampicin in solid lipid nanoparticles. Separation was achieved on a 250×4.6 mm, 5 μm, C-18 column using a linear gradient flow rate of 1.5 ml/min. Isoniazid, pyrazinamide and rifampicin were identified based on their retention times as compared to standards and confirmed with characteristic spectra on a spectrophotometer at 238 nm and eluted at 3.787, 4.173 and 11.273 min, respectively, achieved within 20 min. This method was linear, precise with % RSD values of 0.18 % for isoniazid, 0.15 % for pyrazinamide and 0.47 % for rifampicin, accurate with mean recovery yields of 101.312 % for isoniazid, 99.910 % for pyrazinamide and 99.767 % for rifampicin and selective over the concentration range of 10-150 % for all the three drugs. This method is suitable due to its simplicity and accuracy for routine quality control and stability analysis of antitubercular drugs-loaded solid lipid nanoparticles.

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An Overview   International Conference on Harmonisation and ICH (Q1) Stability Testing Guideline for Pharmaceutical Development

An Overview International Conference on Harmonisation and ICH (Q1) Stability Testing Guideline for Pharmaceutical Development

Abstract: The international conference on harmonisations is the invention of three regulatory agency USA, JAPAN, EUROPE. The ICH bringing together with regulatory affair for registration of product and scientific, technical aspect. The mission of the ICH is to improve worldwide harmonization with safety and efficacy also registration and development of high quality with good manner.

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Nonclinical cardiovascular safety of pitolisant: comparing International Conference on Harmonization S7B and Comprehensive in vitro Pro arrhythmia Assay initiative studies

Nonclinical cardiovascular safety of pitolisant: comparing International Conference on Harmonization S7B and Comprehensive in vitro Pro arrhythmia Assay initiative studies

ter a stabilization period of at least 1 h, action potentials typical for Purkinje fi bres were recorded. Action potential re- producibility and stability were confirmed during a further 20 min stabilization period. The preparation was then superfused with experimental solutions which included 0.1, 1 and 10 μ M pitolisant and 0.1 μ M dofetilide alone or to- gether with 10 μM pitolisant. Each was applied for 20 min to enable steady state to be reached. In addition, the emer- gence of early after-depolarizations (EADs), favoured by cal- cium loading during the late phase 2 of the prolonged action potential, is recognized as a better marker of pro- arrhythmic potential than APD prolongation alone. Hence, we investigated the effects of 1, 3 and 10 μM of pitolisant in rabbit Purkinje fi bres that exhibited induced EADs and trig- gered activity [manifested in vivo as torsade de pointes (TdP) and/or ventricular tachycardia] caused by 0.1 μ M dofetilide, a prototype class III antiarrhythmic drug.

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Formulation and Evaluation of Mouth Dissolving Film of Ropinirole Hydrochloride by Using Pullulan Polymers

Formulation and Evaluation of Mouth Dissolving Film of Ropinirole Hydrochloride by Using Pullulan Polymers

Stability of a drug has been defined as the ability of a particular formulation in a specific container, to remain within its physical, chemical, therapeutic and toxicological specifications.The purpose of stability study is to provide evidence on the quality of a drug substance or drug product which varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Recommended storage conditions, re-test periods and shelf-lives are to be established.The International Conference of Harmonization (ICH) Guidelines titled, “stability testing of New Drug substance and products” (QIA) describes the stability test requirements for drug registration application in the European Union, Japan and the United States of America. ICH specifies the length of study and storage conditions

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Development and Validation of a stability indicating RP-HPLC method for simultaneous determination of Telmisartan, Chlorthalidone and Cilnidipine in pharmaceutical combined dosage forms

Development and Validation of a stability indicating RP-HPLC method for simultaneous determination of Telmisartan, Chlorthalidone and Cilnidipine in pharmaceutical combined dosage forms

The parent drug stability test guideline Q1A (R2) issued by the International Conference on Harmonization (ICH) suggests that stress testing is an essential part of development strategy and is carried out under more severe condition than accelerated conditions. These studies provide information to establish its inherent stability characteristics of the molecule such as the degradation pathways, leading to identification of degradation products and hence supporting the suitability of the proposed analytical procedures [6–7]. According to ICH guidelines stress testing should include the effect of temperature, light, oxidizing agents and susceptibility across a wide range of pH values and separation of drugs from degradation products [8]. It is also suggested that analysis of stability sample should be carried out using validated stability testing methods.

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Analytical method development and validation of simultaneous estimation of dosulepin and methylcobalamin in tablet dosage form by RP-HPLC

Analytical method development and validation of simultaneous estimation of dosulepin and methylcobalamin in tablet dosage form by RP-HPLC

The proposed RP-HPLC method was validated as per International Conference on Harmonization (ICH) guidelines, and found to be applicable for routine quality control analysis for the simultaneous estimation of Dosulepin and Methylcobalamin using isocratic mode of elution. The results of linearity, precision, accuracy and specificity, proved to be within the limits. The proposed method is highly sensitive, reproducible, reliable, rapid and specific. Hence, this method can easily and conveniently adopt for routine quality control analysis of Dosulepin and Methylcobalamin in its pharmaceutical dosage forms.

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Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study

Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study

restricted to 20–40 g/day; a FD with a 7-day fast every 6 months and 14-h daily intermittent fasting in between; and a SD that is predominantly vegetarian and fat- modified as recommended by the German Nutrition So- ciety. The institutional review board of Charité—Univer- sitätsmedizin Berlin approved the study and written informed consent is obtained from all participants prior to study entry (Additional files 1 and 2). The study is conducted in accordance with the Declaration of Helsinki in its currently applicable version, the guide- lines of the International Conference on Harmonization of Good Clinical Practice (ICH-GCP) and applicable German laws. For further details refer to the SPIRIT checklist (Additional file 3).

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DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF NIMODIPINE CONTENT BY UVSPECTROSCOPIC METHOD

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF NIMODIPINE CONTENT BY UVSPECTROSCOPIC METHOD

matrix, etc. Specificity was done by scanning of diluent solution and Standard solution of Nimodipine having concentrations 12 µg/ml in Spectrophotometric range from 200 nm to 400 nm to check specific absorption maxima at predefined wavelength i.e. 239.0 nm and solution stability study performed to evaluate the solution stability at different time interval up to 26 hrs.

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"The International dimension of the harmonization of accounting standards in the EU"

"The International dimension of the harmonization of accounting standards in the EU"

The marginalization of continental Europe’s capital markets was the key driver for greater accounting standards’ harmonization. However, given the mitigated success that the EU had experienced with the Fourth and Seventh Directives, it seemed that creating common “European” accounting standards through a European Accounting Standards Committee or Board would most probably prove difficult. Moreover, European standards would not necessarily solve the problem of capital market marginalization, unless they were close to the standards used in the UK and the US. The Securities and Exchange Commission (SEC), the US capital market regulator, had already refused to recognize the validity of European accounting standards as found in the two accounting directives (Haller 2002, 164). Consequently, the EU had three policy options available to it: UK, US or IASB accounting standards. Adopting UK or US standards for the whole of Europe was not justifiable politically, given the amicable geo-political and geo-economic rivalries between continental (West) European states and their Anglo-Saxon counterparts (get reference or interview). For continental EU member state governments, either of these two options would be akin to publicly admitting that their accounting standards were inferior to UK or US ones. Adopting IASB standards, even if closely aligned with Anglo-Saxon standards, was a face-saving alternative. 5 However, it could also be a socially-optimal policy choice if it eventually led to the adoption of IASB standards across the world, whereby international accounting standards would be truly standardized with the same common applicable financial reporting rules across the globe.

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Title:  THE MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES- SCOPE AND STRUCTURE Author:  Nikitha Keyword:  MeDRA, medical terminology, WHO safety database, safety codingPage No:  01-05Download PDF

Title: THE MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES- SCOPE AND STRUCTURE Author: Nikitha Keyword: MeDRA, medical terminology, WHO safety database, safety codingPage No: 01-05Download PDF

MedDRA (Medical Dictionary for Regulatory Activities is a rich and highly specific standardized medical terminology developed by ICH (International Conference on Harmonization) to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorized for sale. Products covered by the scope of MedDRA include pharmaceuticals, vaccines and drug-device combination products. ICH recognized that the use of different terminologies at different stages in the course of developing medicines made it difficult to cross- reference and analyse data. Converting data from one terminology to another cost time, resources and resulted in the inevitable loss or distortion of data. In view of these challenges, ICH created the MedDRA to facilitate the exchange of information through standardization. Each MedDRA term assigned an 8-digit numeric code, the code is non-expressive, Codes can fulfill a data field in various electronic submission types (e.g., E2B), initially assigned alphabetically by term starting with 10000001, new terms are assigned sequentially, and supplemental terms are assigned codes. MedDRA is fully implemented in the WHO global safety database allowing entry and retrieval of information in either MedDRA or WHO-ART (Adverse Reaction Terminology). A mapping bridge is kept updated by WHO and ICH, to allow conversion of WHO-ART coded data into MedDRA, allowing users to readily convert their data and use MedDRA.

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Good collaborative practice: reforming capacity building governance of international health research partnerships

Good collaborative practice: reforming capacity building governance of international health research partnerships

Endorsing the role of capacity building in partnerships has been reinforced by the United Nations Sustainable Development Goals (SDGs), 2015, (agreed upon by 193 countries) and the CIOMS guidelines (2016). These two re- cently published guidance documents incorporate capacity building into the standards they set, and this indicates com- mitment to a change in approach, at least within policy. In particular, Goal 17 of SDG states, “Enhance North-South, South-South and triangular regional and international co- operation on and access to science, technology, and innovation and enhance knowledge sharing on mutually agreed terms.” Additionally, Goal 17 also has a standalone Capacity Building Task which states, “Enhance international support for implementing effective and targeted capacity- building in developing countries to support national plans to implement all the sustainable development goals, includ- ing through North-South, South-South, and triangular cooperation.” These high-level international commitments now need to be translated into practical activities on the ground. The responsibility to do so rests with governments, legislatures, industry, NGOs and civil society.

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HIGH – PERFORMANCE LIQUID CHROMATOGRAPHY METHOD VALIDATION AND DEVELOPMENT STRATEGY FOR RIFABUTIN

HIGH – PERFORMANCE LIQUID CHROMATOGRAPHY METHOD VALIDATION AND DEVELOPMENT STRATEGY FOR RIFABUTIN

ABSTRACT: A simple, economical, accurate and precise high performance liquid chromatographic method was developed and validated for the determination of rifabutin. A Shimadzu LC-2010C HT version 3.01 system using a C-18 column with dimensions of 250 × 4.6 mm and silica particle size of 5 μm. Isocratic elution was employed with methanol, acetonitrile and water (75:25 v/v) were used. The flow rate was 1 ml/min, and effluents were monitored at 242 nm. The HPLC method was extensively validated for linearity, accuracy, precision (Interday precision, Intraday precision), repeatability and robustness. The exalted results receive of a drug were procured all significance values were established to be under the acceptable range in International Conference of Harmonization (ICH) guidelines requirements. The results demonstrate that the developed HPLC modus could be successfully used up for identification and quantification of Rifabutin in any form of the drug, with high resolution, accuracy, and precision.

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Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols

In Cameroon, the Pharmacovigilance unit is in charge of drug safety surveillance while the National ethics committee is involved in national regulatory authorities of drugs and vaccines. There is political awareness of pharmacovigilance and its role to ensure the safety of pharmaceutical products [10] and on the organization and functioning of the National ethics Committee for the safety of research participants [11, 12]. But National guidelines to regulate research involving human partici- pants and clinical/field trials do not exist. Drugs are ad- ministered in health facilities during clinical trials and in some health programs, yet adverse event resulting from these trials are usually not reported to these two bodies as international guidelines recommend. This study was therefore conducted on clinical trial protocols to assess how much investigators and sponsors have planned to assess adverse events during clinical trials. That is, how much they have planned to collect data on adverse events, investigate them and discuss objectively whether or not the benefit outweighs the risk. This assessment was done by determining the proportion of clinical trials

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Development and validation of stability-indicating HPLC method for simultaneous estimation of cefixime and linezolid

Development and validation of stability-indicating HPLC method for simultaneous estimation of cefixime and linezolid

A stability‑indicating reverse phase high performance liquid chromatography method was developed and validated for cefixime and linezolid. The wavelength selected for quantitation was 276 nm. The method has been validated for linearity, accuracy, precision, robustness, limit of detection and limit of quantitation. Linearity was observed in the concentration range of 2‑12 µg/ml for cefixime and 6‑36 µg/ml for linezolid. For RP‑HPLC, the separation was achieved by Phenomenex Luna C 18 (250×4.6 mm) 5 µm column using phosphate buffer (pH 7):methanol (60:40 v/v) as mobile phase with flow rate 1 ml/min. The retention time of cefixime and linezolid were found to be 3.127 min and 11.986 min, respectively. During force degradation, drug product was exposed to hydrolysis (acid and base hydrolysis), H 2 O 2 , thermal degradation and photo degradation. The % degradation was found to be 10 to 20% for both cefixime and linezolid in the given condition. The method specifically estimates both the drugs in presence of all the degradants generated during forced degradation study. The developed methods were simple, specific and economic, which can be used for simultaneous estimation of cefixime and linezolid in tablet dosage form. Key words: Cefixime, Linezolid, RP‑HPLC method, forced degradation and validation

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"The United States Food and Drug Administration: Its role, authority, history, harmonization activities, and cooperation with the European Union."

"The United States Food and Drug Administration: Its role, authority, history, harmonization activities, and cooperation with the European Union."

The difficulties in the past two or three years due to perceptions about biotechnology among consumers, particularly in Europe, have led to interest in increasing United States-European Union activities on this topic. There is generally agreement between FDA and the European Commission as to the science and many policy matters. In particular, Commission officials agree that biotechnology is not in need of a special regulatory scheme but can be handled in accordance with established processes for approval of new foods and food additives, pesticides, drugs, and other products. Within some European Union member states, however, the issue of biotechnology is extremely controversial. These views are reflected in consumer organizations active in the Europe and the United States, the green (environmental) parties in the European Parliament, 28 and even in the European Council, the principal European Union legislative body. Even putting aside international organizations such as OECD and Codex that have activities on biotechnology, we now have a plethora of bilateral fora for discussing this topic, and how to reduce public concern about biotechnology products that have been shown to be safe. Biotechnology is discussed regularly during FDA's bilaterals with the European Commission, in broader United States-European Union consultations such as a periodic meeting known as the United States-European Union Biotechnology Task Force. 29 A conference under

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RP UPLC method development and validation for the simultaneous estimation of proguanil and atovaquone in pharmaceutical dosage form

RP UPLC method development and validation for the simultaneous estimation of proguanil and atovaquone in pharmaceutical dosage form

The proposed method gave good resolution between PRG and ATV within short Analysis time (< 5.0 min). Solution stability studies showed that the active pharmaceutical ingredients remained stable for 24 h at room temperature. The changes in flow rate, composition of mobile phase, and temperature of column did not affect the percentage assay of drug, confirming the robustness of the method. Ruggedness of the method was confirmed as no significant changes were observed on analysis using different instrument. High percentage recovery of drug shows the method is free from interference of Excipients present in the formulation. Thus the proposed method is simple, rapid, sensitive, specific, accurate, and precise, and does not involve complicated sample preparation procedures.

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Conference on Housing, Stability, and the Macroeconomy: International Perspectives

Conference on Housing, Stability, and the Macroeconomy: International Perspectives

Where does the analysis of the recent crisis leave us? Claessens (2015b) picks up some of the themes in many of the papers in this special issue. How can we interpret the current recovery in house prices in many crisis countries? Is this recovery driven by fundamentals or are we observing a new bubble? More generally, what are the best ways to reduce the boom and bust pattern of housing that has had such adverse consequences for the real economy and financial stability? And what are the appropriate tools to deal with the overhang of a house price bust? To answer these questions, we need better price data and better models. But even with better data, can we detect bubbles and know when to prick them? Also, do the same macroprudential tools work as well in restraining a boom as they can help a housing market come out of a bust? Finally, aside from prudential considerations, there are broader questions about the factors that drive the supply and demand for housing finance. For instance, what should be the relative roles of banks, non-banks and markets in providing housing finance? What is the optimal market structure for the housing finance industry? What is the role of the state beyond prudential regulation: should there be increased regulation of the construction sector and the land market? Is a predominantly owner-occupied housing market really superior to a rental-dominated one?

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Volume 3 | Issue 3 - 2013

Volume 3 | Issue 3 - 2013

Results: The retention time of Hydrochlorothiazide and Eprosartan was found to be 0.902 min and 2.075 min respectively. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to linearity, limit of detection, limit of quantification, accuracy, precision and robustness. The precision was found to be within the limits. The linearity studies indicated the drug obeys Beer’s law and revealed the specified range of linearity for Hydrochlorothiazide was between 1.25-6.25µg/ml and for Eprosartan 25-125µg/ml. The robustness was observed from the insignificant variation in the analysis by changes in flow rate, mobile phase ratio.

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