A Comprehensive Review on Assessment and Key Control Strategies for Impurities in Drug Development with a Special Emphasis on Post-marketing Surveillance

Author(s):  
Nikita Tapkir ◽  
Fatema Soni ◽  
Amit Kumar Sahu ◽  
Tarang Jadav ◽  
Rakesh K. Tekade ◽  
...  
Author(s):  
Estella Achick Tembe Fokunang ◽  
Bruna Njeba ◽  
Marie Jose Essi ◽  
Rose Ngono Abondo ◽  
Banin Andrew Nyuki ◽  
...  

The drug discovery and development processes are designed to guarantee that drugs are efficacious, nontoxic and of high standards of quality for human consumption. However, patient’s population with access to drugs at approval is only a fraction of the final target population. Therefore, a thorough understanding of the safety of medicines is generally only achieved after the marketing authorization of the drug, followed by pharmacovigilance or post marketing surveillance. Pharmacovigilance (PHV) is defined by WHO as “the science and activities that deals with the detection, assessment, understanding and prevention of the adverse drug reactions or any other possible drug-related interactions”. Health professionals, patients, drug manufacturers and drug regulatory authorities are therefore highly involved in the practice of PHV. Cameroon imports 95 % of drugs and health care products. Therefore, an effective mastery of the knowledge, attitude and practice of PHV will help to elaborate the development of our pharmacovigilance systems. This paper gives an overview of pharmacovigilance in Cameroon for unlocking the drug development process focusing on the past, present and future.


1983 ◽  
Vol 22 (03) ◽  
pp. 135-148 ◽  
Author(s):  
T. Kitaguchi ◽  
T. Nojiri ◽  
S. Suzuki ◽  
T. Fukita ◽  
T. Kawana

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.


2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  

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