Perception of various stakeholders regarding clinical drug trial industry in India [0.03%]
印度各利益相关方对临床药物试验行业的看法
Rakesh M Parikh,Kirti Pandia,Mahesh Goyal et al.
Rakesh M Parikh et al.
Context: Though India has been thought to be an ideal destination for conduct of clinical drug trials, other smaller countries seem to be doing better. The pace of growth observed during 2005-2009 seems to be plateaued in...
Ashwini Mathur
Ashwini Mathur
New, strategic outsourcing models to meet changing clinical development needs [0.03%]
满足临床开发需求的战略型外包新模式
Janet Jones,Michael Minor
Janet Jones
The impact of increasing clinical costs and the need for more data to support higher efficacy demands and overcome regulatory hurdles for market entry means that every Company is faced with the challenge of how to do more with a smaller bud...
Vivek Ahuja,Varun Sharma
Vivek Ahuja
Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to b...
Tushar Vijay Sakpal
Tushar Vijay Sakpal
Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, ...
Getting ready for inspection of investigational site at short notice [0.03%]
临时应对稽查员对试验现场的视察准备工作的注意事项
Rajendra Talele
Rajendra Talele
India is becoming an attractive destination for drug development and clinical research. This is evidenced by the three fold increment in clinical trial applications in last four years to the office of Drugs Controller General of India (DCGI...
Tushar Tewari,Shoibal Mukherjee
Tushar Tewari
The use of microdose pharmacokinetic studies as an essential tool in drug development is still to catch on. While this approach promises potential cost savings and a quantum leap in efficiencies of the drug development process, major hurdle...
Viraj Suvarna
Viraj Suvarna
Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study. Phase IV is also an important phase of drug development. In particular, the real world effectiveness of a drug as evaluated in a...