Clinical evaluation of antidepressant drugs; Guidelines from authorities

1992 ◽  
Vol 4 (3) ◽  
pp. 57-62
Author(s):  
J.M. Keppel Hesselink
Keyword(s):  
Clinical Evaluation ◽  
Antidepressant Drugs ◽  
World Health Organisation ◽  
Phase Iii ◽  
World Health ◽  
Medicinal Products ◽  
Ethical Problems ◽  
Phase Iii Trials ◽  
Pharmaceutical Industries ◽  
New Chemical Entity

SummaryFood and Drug Administration, World Health Organisation and Committee on Proprietary Medicinal Products have published guidelines with recommendations how to conduct clinical trials. The guidelines for the clinical evaluation of antidepressant drugs contain a great variety of recommendations how to design phase I, phase II and phase III trials. Especially the pharmaceutical industry will follow these guidelines as much as possible to make the chances to register a new chemical entity as optimal as possible. While FDA and CPMP guidelines are primarily meant to be read by representatives from the pharmaceutical industries, the WHO guidelines give mainly information for clinicians. For the psychiatrist with interest in clinical research on antidepressants it is mandatory to know about the existence of these different guidelines. Fundamental differences between the guidelines do not exist; the methodological and ethical problems concerning placebo-use and relapse-recurrence problems are especially emphasized in the CPMP-guidelines.

scholarly journals Understanding Substance Abuse and its Correlation with Social Changes in Sikkim: A Sociological Study

2019 ◽  
Vol 15 (3) ◽  
pp. 48
Author(s):  
Peter Rai
Keyword(s):  
Drug Abuse ◽  
Drug Use ◽  
Drug Addiction ◽  
Drug Users ◽  
World Health Organisation ◽  
The Philippines ◽  
World Health ◽  
Easy Access ◽  
Sociological Study ◽  
Pharmaceutical Industries

<p>In contemporary society, the full-fledged impact of modernisation and globalisation which has given the free movement of people, goods and money across the countries of the world can be witnessed. This has also opened the economic opportunities among the individuals and communities in the society, which has become a new way of life. Society has changed over the years and activities of the people have also undergone social change. Even the trend of taking drugs has changed with change in society. Traditionally used drugs have been replaced by modern synthetic drugs. The proliferation of pharmaceutical industries, which manufactures narcotic drugs, has, directly and indirectly, encouraged the use and abuse of drugs due to easy access in the market. The epidemic of illicit drug users in the global society has increased significantly and simultaneously related crimes in society. </p><p>Drug abuse is global phenomena. A drug is a biological substance, synthetic or natural, which is taken primarily for non-dietary needs, and it is a substance, which affects the functioning of the mind and body or both. Globally, according to UNODC estimate, in 2009, between 149 and 272 million people, or 3.3% to 6.1% of the population aged 15-64, had used illicit substance once in the previous year. Cannabis and ATS (Amphetamine-type stimulants) are two important drugs which are commonly used worldwide. Within Asia, ATS ranks as the main drug of abuse in Thailand, Japan, Republic of Korea and the Philippines, and also China, Myanmar and Indonesia are in the second rank (UNODC, 2004). Heroin, cocaine and other drugs kill around 0.2 million people each year and also causes health problems with incurable diseases. The European Monitoring Centre for Drug and Drug Addiction (EMCDDA) defines the problem of drug use as, “injecting drug use or long duration regular use of opium, cocaine and amphetamines”. World Health Organisation (WHO), defines drug addiction as a ‘disease,’ and the American Psychiatric Association, define drug abuse as the ‘illicit consumption of any naturally occurring of pharmaceutical substance for the purpose of changing the way, in which a person feels, thinks or behaves, without understanding or taking into consideration the damaging physical and mental side-effects that are caused.'</p>

scholarly journals A COMPREHENSIVE REVIEW ON COMPARISON OF GDOCP IN PHARMACEUTICAL MANUFACTURING UNIT AS PER EUROPEAN AND WHO GUIDELINES

2021 ◽  
pp. 21-24
Author(s):  
MALE TEJASWI ◽  
VINOD KUMAR K. ◽  
CHITHRA SHEKAR C. ◽  
SRIKANTH K.
Keyword(s):  
Pharmaceutical Industry ◽  
National Level ◽  
World Health Organisation ◽  
Pharmaceutical Manufacturing ◽  
World Health ◽  
Who Guidelines ◽  
Medicinal Products ◽  
Public And Private ◽  
Private Organizations ◽  
Health Products

To review the good documentation practices in the pharmaceutical industry as per the guidelines provided in the European Commission and WHO (World Health Organisation). GDocP is a systematic method of planning, evaluating, approving, issuing, documenting, preserving, and archiving records. GDocP is a must when operating in an atmosphere of existing GMP. To provide an overview of good documentation practices for those employed in the pharmaceutical and healthcare sectors. The GDocP stands for good documentation practice which can be described as an integral part of quality assurance (QA) and thus related to all aspects of GMP. There are very few articles related to the comparison of GDocP in the pharmaceutical manufacturing unit as per European and WHO guidelines hence we are trying to develop a study on the comparison of GDocP guidelines. Public and private organizations, institutions, and regulatory authorities working and cooperating and with the pharmaceutical industry are involved at the international and national level to reach a consensus on the guidelines and laws for the production of medicinal products for human. This article explains how these participants work and cooperate and set out current regulations along the lines of the European community and WHO referencing, where appropriate, the practiced guidelines, outside space regulatory action referred to above. In this way, the goal is to achieve exceptional standards of quality, protection, and efficacy in the manufacture of health products.

Phase III Vaccines for SARS-CoV-2: A Review of Development and Available Data

2020 ◽  
Vol 6 (5) ◽  
Author(s):  
Hamid Ehsan ◽  
Muhammad Sana ◽  
Ayesha Sarwar ◽  
Nazma Hanif ◽  
Sana Khan
Keyword(s):  
Phase I ◽  
Disease Transmission ◽  
Viral Vector ◽  
Safety Data ◽  
Phase Iii ◽  
World Health ◽  
Effective Vaccine ◽  
High Risk Population ◽  
Evaluation Phase ◽  
Phase Iii Trials

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19), has caused more than 35 million confirmed cases and more than 1 million deaths so far. This has led to global efforts to find effective treatment and vaccination to control disease transmission and decrease severity. The current efforts are focused on developing a vaccine that is safe and effective after one or two doses, provides protection for a minimum of six months, provides protection for high-risk population and reduces the risk of onward viral transmission. In this review, we summarize available information related to the development and safety profile of these phase III vaccines against SARS-CoV-2. Methods Literature search was performed on PubMed, Cochrane and ClinicalTrial.gov using keywords like “SARS-CoV-2”, “COVID-19”, and “Phase III vaccines”. Two individuals performed screening of the resultant library. We assessed different articles for information focusing on vaccines in phase III trials. Results As of September 3, 2020 update by the World Health Organization (WHO), there are currently more than 137 candidate vaccines undergoing preclinical development and of these 34 candidate vaccines are in the clinical evaluation phase, 18 are in phase I and 5 are in phase II. Currently, there are 9 vaccines in the phase III development process. Conclusion Multiple phase III trials of COVID-19 vaccines are in progress across the globe, highlighting the collaborative international efforts to develop a safe and effective vaccine. The available efficacy and safety data of phase I/II trials of these vaccines have shown promising results. Pharmaceutical companies are using different strategies including inactivated vaccines, RNA vaccines, recombinant viral vector vaccines and live attenuated BCG vaccine.

scholarly journals Drug promotional literature: Does pharmaceutical industry follow WHO guidelines?

2017 ◽  
Vol 6 (7) ◽  
pp. 1790
Author(s):  
Priyanka G. Sonwane ◽  
Ashwini V. Karve
Keyword(s):  
Pharmaceutical Industry ◽  
Tertiary Care ◽  
World Health Organisation ◽  
New Drugs ◽  
World Health ◽  
Who Guidelines ◽  
Visual Aids ◽  
Cross Sectional ◽  
Therapeutic Uses ◽  
Pharmaceutical Industries

Background: Promotional literature is an important tool for both pharmaceutical industry (marketing strategy) and physicians (up to date knowledge). Important ways of doing drug promotion are visual aids, leave behind, flip charts. World Health Organisation has laid down criteria for drug promotional literature.Methods: A cross sectional observational study was performed in Department of Pharmacology, Tertiary Care Teaching Hospital of Mumbai. Total 137 drug promotional Literatures were randomly collected from different outpatient departments out of which 37 were excluded. 100 drug promotional literatures were evaluated by using WHO guidelines.Results: None of drug promotional literature fulfilled all WHO criteria. Though name of the active ingredient and brand name featured in 100% of the literature, 69% of them lacked information related to adverse drug reactions, precautions, contraindications and warnings. The approved therapeutic uses were mentioned in 96% but the dosage regimen in 38% only. Majority of the literature (80%) did not mention the drug interactions. References were given in 76% of the literature of which 87% were from journal article.Conclusions: Pharmaceutical industries do not follow WHO guidelines in toto to promote their product. Thus more strict regulations need to be implemented for proper promotion and dissemination of information about new drugs.

A Collaborative Study to Establish the Second International Standard for Streptokinase

1990 ◽  
Vol 64 (02) ◽  
pp. 267-269 ◽  
Author(s):  
A B Heath ◽  
P J Gaffney
Keyword(s):  
High Purity ◽  
Collaborative Study ◽  
World Health Organisation ◽  
World Health ◽  
Clot Lysis ◽  
Current Standard ◽  
International Standard ◽  
Accelerated Degradation ◽  
The World ◽  
International Collaborative Study

SummaryAn International Standard for Streptokinase - Streptodomase (62/7) has been used to calibrate high purity clinical batches of SK since 1965. An international collaborative study, involving six laboratories, was undertaken to replace this standard with a high purity standard for SK. Two candidate preparations (88/826 and 88/824) were compared by a clot lysis assay with the current standard (62/7). Potencies of 671 i.u. and 461 i.u. were established for preparations A (88/826) and B (88/824), respectively.Either preparation appeared suitable to serve as a standard for SK. However, each ampoule of preparation A (88/826) contains a more appropriate amount of SK activity for potency testing, and is therefore preferred. Accelerated degradation tests indicate that preparation A (88/826) is very stable.The high purity streptokinase preparation, coded 88/826, has been established by the World Health Organisation as the 2nd International Standard for Streptokinase, with an assigned potency of 700 i.u. per ampoule.

A Collaborative Study to Establish an International Standard for Alpha-Thrombin

1992 ◽  
Vol 67 (04) ◽  
pp. 424-427 ◽  
Author(s):  
P J Gaffney ◽  
A B Heath ◽  
J W Fenton II
Keyword(s):  
Elevated Temperatures ◽  
Collaborative Study ◽  
World Health Organisation ◽  
Significant Loss ◽  
Thrombin Inhibitors ◽  
World Health ◽  
Expert Committee ◽  
International Standard ◽  
Assay Procedure ◽  
And Control

SummarySince 1975 an International Standard for Thrombin of low purity has been used. While this standard was stable and of value for calibrating thrombins of unknown potency the need for a pure a-thrombin standard arose both for accurate calibration and for precise measurement of thrombin inhibitors, notably hirudin. An international collaborative study was undertaken to establish the potency and stability of an ampouled pure a-thrombin preparation. A potency of 97.5 international units (95% confidence limits 86.5-98.5) was established for the new a-thrombin standard (89/ 588) using a clotting-assay procedure. Stability data at various elevated temperatures indicated that the standard could be transported and stored with no significant loss of potency.Ampoules of lyophilised a-thrombin (coded 89/588) have been recommended as an International Standard for a-thrombin with an assigned potency of 100 international units per ampoule by the International Society for Thrombosis and Haemostasis (Thrombin and its Inhibitors Sub-Committee) in Barcelona, Spain in July 1990 while the Expert Committee on Biological Standardisation and Control of the World Health Organisation will consider its status at its next meeting in Geneva in 1991.

ANTARA SUNNAH DAN TRADISI (Khitan Muallaf Perempuan Baligh di Jayapura, Papua)

1970 ◽  
Vol 9 (2) ◽  
pp. 271-284
Author(s):  
Hendra Yulia Rahman
Keyword(s):  
World Health Organisation ◽  
World Health

Masyarakat Indonesia pada umumnya khususnya yang bergama Islam, memiliki kebiasaan mengkhitankan anak perempuannya dan memandang ini sebagai sunnah, hal ini juga dilakukan masyarakat di negara-negara lain yang memiliki penduduk pemeluk agama Islam. Pada umumnya masyarakat megkhitankan anak perempuannya, ketika masih bayi dan meyakininya sebagai bentuk kewajiban dari perintah agama. Badan kesehatan dunia World Health Organisation (WHO) melakukan pelarangan segala bentuk khitan pada perempuan, karena dianggap sebagai bentuk kekerasan pada perempuan dengan menyakiti dan merusak alat reproduksi perempuan. Khitan perempuan dianggap sebagai tradisi yang sudah lama ada tengah-tengah masyarakat baik yang muslim maupun yang non muslim, yang dalam pelaksanaannya lebih dimaksudkan sebagai upaya pengontrolan seksualitas perempuan. Muallaf perempuan baligh khususnya di wilayah kota Jayapura, Papua rata-rata melakukan khitan, yang menurut mereka merupakan bagian dari perintah agama. Bahwasanya khitan muallaf perempuan baligh di kota Jayapaura merupakan sebuah tradisi yang terus berlangsung, dan tradisi tersebut sejalan dengan sunnah.

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