Articles

8 June 2017

A STUDY OF PROCEDURES FOR DOSSIER PREPARATION AND THEIR MARKETING AUTHORISATION IN DIFFERENT COUNTRIES OF SELECTED DRUG(S)

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ABOUT AUTHORS
¹Veerendra Kr. Gautam*, ²Mohamad. Irfan
1Executive in Drug Regulatory Affairs Department; East African (India) Overseas
¹120 Suncity Business Tower,Sector-54, Gurgaon-122002 (Haryana).
²Research Associate; Jubilant Chemsys Ltd.
²D-12, Sector 59, Noida , Uttar Pradesh, India
¹dra.veerendra.gautam@gmail.com;
¹viren.gautam.dra@gmail.com ²mohd.irfan.ivar@gmail.com

Abstract : Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data. This process is governed and permitted by Drug Regulatory Authority of a particular country and process is called as NDA in USA, MAA in EU and other countries as simply Registration Dossier. There are basically two formats for dossier preparation i.e. ICH-CTD and ACTD. ICH-CTD followed by ICH countries as well as low economical or developing countries where as ACTD is followed by ASEAN countries. ACTD act as bridge between regulatory requirements of developed and developing countries. Also if both guidelines of CTD and ACTD can be harmonized then differences and variation between both guidelines can be minimized.
2 June 2017

A REVIEW ON INTERNATIONAL REGULATORY CONCERN ON ROLE AND RESPONSIBILITY OF PHARMACEUTICAL HIGHER MANAGEMENT

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ABOUT AUTHORS
Suleman S. khoja * ¹, Sohil S. khoja ¹, Karim R. Panjwani¹,
Jagdish Ray ¹ , Parthkumar H. chauhan ²
¹ Resource person in Pharmaceutical Quality Assurance,
Audit and Compliance, Vapi .
² Resource person in Quality Assurance,
Navsari
^*premukhoja@gmail.com

ABSTRACT:
It has been always International Regulatory concern on Role and Responsibility of Pharmaceutical Higher Management in this review article we have taken some of the concern and how responsible leadership should ensure the support and commitment of staff at all levels and sites within the organization to the Pharmaceutical Quality System ,management review , Quality committee and to make a platform for leadership engagement, awareness and decision making around quality and process performance. Implement new controls as per GMP Guidelines to check impact and management tool for identification and reduction of human Errors in pharmaceuticals Industry.

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1 June 2017

A PROSPECTIVE STUDY ON ROLE OF DOCTOR OF PHARMACY IN IMPROVING QUALITY OF LIFE OF HIV PATIENTS BY PATIENT COUNSELLING IN AN ANTIRETROVIRAL THERAPY WARD OF A TERTIARY CARE TEACHING HOSPITAL

ABOUT AUTHORS
M. Manasa Rekha*,
Department of Pharmacy Practice,
Annamacharya college of Pharmacy,
Rajampet, Andhra Pradesh, India.
*manasarekharoyal@gmail.com

ABSTRACT:
The study aims to assess the role of clinical pharmacist in Improving the quality of life of HIV patients in an antiretroviral therapy wards of a teritary care teaching hospital
24 May 2017

GENOTOXICITY

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ABOUT AUTHORS
L Reddenna¹*, Dr. P. Venkatesh¹, K Siva Kumar², A Sai keshava Reddy²
1* Department of Pharmacy Practice,
Jagan’s College of Pharmacy,
Nellore, Andhra Pradesh, India
² Department of Pharmacy Practice,
Nirmala College of Pharmacy,
Kadapa, Andhra Pradesh, India
*reddennapharmd@gmail.com

ABSTRACT
Genotoxicity describes the possessions of chemical agents that damage the genetic information within a cell causing mutations, which may lead to cancer. Heritable changes can influence either somatic cells of the organism or germ cells to be passed on to future generations. As a result, many urbane techniques including Ames Assay, in vitro and in vivo Toxicology Tests, and Comet Assay have been developed to evaluate the chemicals probable to cause DNA damage that may lead to cancer. The genotoxic substances provoke damage to the genetic material in the cells through exchanges with the DNA sequence and structure. Genotoxicity testing is to resolve if a substrate will sway genetic material or may cause cancer. Genotoxic Chemotherapy is the treatment of cancer with the use of one or more genotoxic drugs. The treatment is traditionally part of standardized regime. By utilizing the destructive properties of genotoxins treatments aims to induce DNA damage into cancer cells.
23 May 2017

STUDY OF IN-VITRO BIOTRANSFORMATION OF PRODRUGS OF ESTER AND AMIDE LINKAGES OF IBUPROFEN, DICLOFENAC SODIUM AND PARACETAMOL IN ACIDIC AND ALKALINE MEDIUM

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ABOUT AUTHOR
Dhrubo Jyoti Sen
Department of Pharmaceutical Chemistry,
Shri Sarvajanik Pharmacy College,
Mehsana, Gujarat, India
dhrubosen69@yahoo.com

ABSTRACT: Our goal is to perform in-vitro biotransformation of Prodrugs of ibuprofen+paracetamol, diclofenac sodium+paracetamol and ibuprofen+diclofenac sodium by acidic and alkaline hydrolysis of both ester (–COO–) and amide (–CONH–) linkages into free drugs and chromatographically separation of their Rt in HPLC. Since both ester (–COO–) and amide (–CONH–) linkages are susceptible for hydrolysis in both acidic pH (gastric pH) and basic pH (intestinal pH) to produce parent drug ibuprofen, diclofenac and paracetamol by biotransformation in in-vivo; so it will be implemented as a Prodrug which can show prolong action on pain and fever after getting release into free parent drug by biotransformation. The HPLC (High Performance Liquid Chromatography) study reports the retention time (Rt) and release kinetics of three Prodrugs by taking HPLC degradation datas of three samples of Prodrugs and individual HPLC datas of parent drugs separately to compare the Rt value of release of three drugs from Prodrugs in both acidic and alkaline pH. Prodrug–A (logP=4.56) releases Ibuprofen & Paracetamol, Prodrug–B (logP=4.90) releases Diclofenac & Paracetamol and Prodrug–C (logP=6.13) releases Ibuprofen & Diclofenac. This is a comparison study of drug release in in-vitro gastric as well as intestinal pH focusing on in-vivo biotransformation. Keywords: Prodrug-A/Prodrug-B/Prodrug-C, Ibuprofen, Paracetamol, Diclofenac sodium, Molecular weight, logP, UV λmax, IR, Mobile phase, TLC-Rf value, HPLC-Rt value, LOD, LOC
22 May 2017

H/H BLOOD GROUP SYSTEM: A RARE BLOOD GROUP

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ABOUT AUTHORS
L Reddenna¹*, Dr. P. Venkatesh¹, K Siva Kumar², A Sai keshava Reddy²
1* Department of Pharmacy Practice,
Jagan’s College of Pharmacy,
Nellore, Andhra Pradesh, India
² Department of Pharmacy Practice,
Nirmala College of Pharmacy, Kadapa, Andhra Pradesh, India
*reddennapharmd@gmail.com

ABSTRACT
The subsistence of a human H/h genetic polymorphism was first recognized by the innovation of an individual devoid of the H antigen on red cells in Bombay who had antibodies in plasma reacting with all the red cells exhibiting the normal red cell ABO phenotypes. These persons were genetically termed as homozygous hh or Bombay phenotype. H-deficient Bombay phenotype is exceptional, since it occurs in about 1 in 10,000 individuals in India and 1 per 1,000,000 individuals in Europe. After the first report of Oh phenotype from Mumbai in 1952 by Bhende, numerous other workers detected this weird phenotype in India. The complexity with the Bombay phenotype is that the individuals having blood group of Bombay phenotype (Oh) can either receive autologous donation or blood from an individual of Bombay phenotype only; no other blood will match in case of an emergency blood transfusion. The aim of present study was to communicate the information about rare blood entity and to review the previous case reports.
21 May 2017

CLINICAL PHARMACIST SPECIALIZED CARE IN MANAGEMENT OF CONGESTIVE HEART FAILURE - A BRIEF REVIEW

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ABOUT AUTHORS
M.S.Umashankar*¹, K.S.Lakshmi, A.Bharath Kumar, A.Porselvi
SRM College of Pharmacy,
SRM University, Kattankulathur,
Tamil Nadu, India
*abharatpharma@gmail.com

ABSTRACT :
It is a critical clinical condition in which more abnormalities in cardiac structure and its functions may impact the ineffectiveness of the heart to supply required oxygen to meet the cellular metabolic demands of the body. Heart is covered with protective layers and express the various functions in the body. Clinically cardiac disease prevalence rises with individual age. Cardiac dysfunction happens because of changes in blood volume, and neurohumoral transmission status. These desirable mechanisms to maintain adequate cardiac output and arterial blood pressure. The neurohumoral responses act as compensatory mechanisms and provokes heart failure by increasing ventricular after load and increasing preload,which further elevates the cardiac failure. Health care system with a clinical pharmacist is well allocated to impact the disease management through identification of risk factors, stage of severity, educating the patients and health care practioners and implementing the awareness programmes, modification of life style interventions with in health care system beneficial to the community may reduce the progression of disease severity.

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19 May 2017

INDIAN DOCTOR, INDIAN PATIENTS & GENERICS: A TRIO OR OPPONENTS

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ABOUT AUTHORS
S.P.Sethy*, Tahseen Sameena, Prathima Patil
Department Of Pharmaceutical Chemistry,
Sushrut Institute of Pharmacy,
Medak, Andhra Pradesh, India
*sarada9439504350@gmail.com

ABSTRACT
This is a review aimed towards the current scenario of health care system in India with respect to the approach of Indian doctors towards the use of generics for a convenient and cost effective healthcare which is a major concern for all Indian citizens and this scenario should get clear for the betterment of Indian patient and the overall healthcare scenario in India. We can say the health care system is four tare system consisting doctors, patients, pharmacist and medicines, so there is a need to establish a significant relation between these four systems for a better health care facility in the country. In this review we have analyzed the Indian doctor’s perception status towards generic medicines, a patient’s feedback status towards generic medicines and from the side of pharmacist in dispensing generics medicines in India. We found that a major part of this system is running out of track and if it remains unsolved an Indian patient can’t expect a cost effective and efficient health services in future
16 May 2017

A REVIEW ON ANALYTICAL METHODS FOR ESTIMATION OF ASPIRIN, CLOPIDOGREL BISULPHATEAND ROSUVASTATIN CALCIUMIN PHARMACEUTICAL DOSAGE FORM

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ABOUT AUTHORS
¹Jyoti Yadav , ²Amit Sharma*
¹Maharishi Dayanad University Rohatak
² NIMS University, Jaipur
*amitsharma84945@gmail.com

ABSTRACT
This review article is intended to highlight the analytical methods of aspirin, clopidogrel and rosuvastatin in individual as well as combined pharmaceutical dosage form. Aspirin, clopidogrel and rosuvastatin play an important role in the various cardiovascular diseases. Aspirin and clopidogrel are the antiplatelet whereas Rosuvastatin is antilipemic agent which are used in the treatment of various cardiovascular diseases, cerebrovascular and peripheral vascular diseases. Now these days these drugs are easily available in the market in their individual form as well as in their combined dosage form. Aspirin, clopidogrel and rosuvastatin are official in the pharmacopoeias .Various analytical methods have been reported for the estimation of these drugs in their individual form as well as in their combined dosage form.
15 May 2017

A REVIEW ON ALCOHOL DRINKING RELATED PROBLEM

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ABOUT AUTHORS
Babita A. Dodke*, Sukeshini B. Lote, Monali B. Wawre, Priyanka R. Waghmare
Dr. R.G.Bhoyar Institute of Pharmaceuitical Education and Research Wardha
*babitadodke@gmail.com

ABSTRACT
There are many forms of excessive drinking that cause substantial risk or harm to the individual. They include high level drinking each day, repeated episodes of drinking to intoxication, drinking that is actually causing physical or mental harm, and drinking that has resulted in the person becoming dependent or addicted to alcohol. Excessive drinking causes illness and distress to the drinker and his or her family and friends. It is a major cause of breakdown in relationships, trauma, hospitalization, prolonged disability and early death. Alcohol-related problems represent an immense economic loss to many communities around the world. Because alcohol is a small molecule it interacts with many neurotransmitter systems in the brain; this makes the action of alcohol in the brain very different from and much more complex than large molecules such as opiates, Alcohol does not lead to an increase of dopamine throughout the brain; it only causes an increase in dopamine in the area of the reward pathway. This reward pathway is comprised primarily of the nucleus accumbens, the VTA (ventral tegmental area), and a part of the prefrontal cortex or amphetamine which simulate a specific neurotransmitter and interact with a specific neurotransmitter system. Alcoholism is a debilitating disorder for the individual and very costly for society this review article provides an evaluation of the literature on the alcohol drinking its effect on life and treatment of various harmful effects of alcohol.