Scope of Pharm.D in India
Indian pharmacy education took a big leap in the year 2008 with The Pharmacy Council of India recognizing the Pharm.D program. This was a move to standardize pharmacy education in India and make it at par with international standards. Numerous universities and colleges in India have launched the Pharm.D program; however the road to success is a steep one with this higher degree program. Continue reading
An update as an addendum to the ICH GCP E6 has been released by European Medicines Agency (EMA) for comments from the public. Continue reading
Tags: Careers in Pharmacovigilance, Pharmacovigilance Training, Online Pharmacovigilance Courses
Pharmaceuticals is regarded as an evergreen industry. Drug safety or Pharmacovigilance is at the center stage of new drug development as well as postmarketing evaluation of approved drugs and devices. This creates a very vital niche for the pharmacovigilance industry inside the much larger and expanding pharmaceutical business. It would be apt to say that if pharmaceutical business is evergreen then pharmacovigilance is greener. Continue reading
Tags: Tropical Medicine, Tropical Medicine Courses, Tropical Medicine Diploma
In the modern era in which air travel has shrunken international boundaries, the study of tropical medicine has gained a more serious relevance for all nations. As a major example the Ebola virus disease (EVD) epidemic that surfaced in early 2014 has brought to limelight the concerns regarding the rapidity at which infectious diseases can cross distant borders and the effect they can have internationally. Continue reading
Many health issues are specific to certain parts of the world based on their geography, socioeconomic and other factors. A branch of international medicine also known has tropical medicine is involved in addressing issues related to health which mainly include communicable diseases common in the tropical and subtropical regions. Continue reading
‘All drugs need to be safe and efficacious’ is an ideal goal and the objective of the pharmaceutical industry, researchers and the regulatory agencies is to come closer to this goal as much as possible. In the public health scenario the concepts of drug safety takes a higher priority due to a wider application of therapeutics outside of a controlled environment of clinical trials with rare and idiosyncratic effects surfacing with experience. Continue reading
A patient support group is constituted as a common forum or locus where patients with common diseases or interests can obtain information about their condition, share feelings and experiences and attain a sense of belonging and acceptance. Even though not being fully representative of the disease population, the pharmaceutical industry has long recognised the marketing potential of such patient groups utilizing them as surrogate marketing tools.
Such patient organisations have a crucial role in the process of translational research by advocating effective and timely access of safe therapies to patients. This aim brings them at the crossroads of the innovation stakeholders, the patients, government and pharmaceutical industry. Continue reading
A micro-segmentation of the research enterprise along with drying up drug pipelines and piling up of un-translated basic science discoveries has prompted all the stakeholders of innovation towards development of translational medicine tools for efficacious and expedited entry of products to the market.
Clinical trials are important and have lately come under scrutiny for their efficiency and exploring scope for improvisation in their traditional designs to de-risk the drug discovery enterprise both at the innovators end and for the patients. Continue reading
CONSORT (Consolidated Standards of Reporting Trials) includes various initiatives formulated by the CONSORT Group to identify and rectify the effects arising from inadequate reporting of randomized controlled trials.
Deficient design and reporting of randomized controlled trials is widely acknowledged and the issues are addressed in the CONSORT statement.
The main document of the CONSORT Group is the CONSORT Statement which is an evidence-based, minimum list of guidelines for reporting randomized controlled trials. It elucidates a standard path for authors to prepare reports of trial results, facilitating their complete and ethical reporting, reducing the publication bias on their results, and further facilitating their critical appraisal and interpretation. Continue reading
Systems biology can describe intricate responses to therapeutic interventions in pre-clinical studies and also provide predictive models for drug safety and efficacy before going for the clinical phases. Systems biology can potentially reduce the R&D expenditure and time by improving target identification and lead quality, better description of pharmacokinetic and toxicity profiles, as well as optimizing clinical trial efficiency.
Before embarking on the costly clinical phases of drug development all the tools predicting the probability of success are always a welcome and so is systems biology. There is increasing realization that regarding the need for CROs to diversify. Early phase contract research organizations (CROs) can develop their capacity to complement the pharmaceutical or biotech industry by making use of in-silico disease models and a virtual patient approach for the identification and validation of targets, develop biomarkers to improve the success rates of clinical trials, and thus expedite the therapeutic translation. Continue reading