The Difficulty in
Readability Testing
Since readability testing became a necessity for better patient understanding of leaflets, there has been a plethora of ways to test a leaflet. To the outsider, presenting a leaflet to a participant, asking a set of preset questions and recording the responses could appear to be enough to gauge the user friendliness of a Package Leaflet (PL). However, a simple yes/no dichotomic approach quickly yields an unforeseen variable which can aptly be demonstrated in the following hypothetical situation.
During a readability test, the participant is asked a question regarding a contraindication of the medicine. After re-reading the entire leaflet, the participant is finally able to locate the correct information but over ten minutes have passed since the original question was asked by the interviewer. As the participant has found the information, the answer is marked correct.
Translate this situation to real life: ten minutes of anaphylactic shock is ten minutes too long for a patient taking the medicine to realise the PL contained this contraindication.
FDA Announces Measures to Improve Generic Drug Access
The Food and Drug Administration (FDA) im March 2004 announced that it will provide more information to the public to help generic drug applicants determine if they are eligible for 180-day marketing exclusivity for their products. This period of marketing exclusivity is generally provided to the first generic drug that challenges a patent for the innovator product.
Introduction to the regulatory environment, dossiers, electronic submissions and its supportive documents
This course will offer insight into the regulatory environment of human pharmaceutical products, thereby focusing on the EU procedures and submissions and focusing on eCTD for global use. Emphasis will be on understanding the multidisciplinary tasks for the preparation and maintenance of regulatory documents.
16 & 17 June 2009 - De Baak Seaside - Noordwijk - The Netherlands - hosted by eCTDconsultancy
Pricing and Reimbursement in Key Asia Pacific Markets
While some markets offer pharma major advantages, others still have some way to go before multinationals can compete effectively against domestic players
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The Asia-Pacific region is attracting plenty of attention from foreign pharmaceutical players because of its rapid economic growth, and this is an enticing prospect for foreign companies wishing to enter the markets. However a number of key reforms and pricing and reimbursement (P&R) developments are set to change the healthcare environment in the future.
It's essential that pharma is aware of the different P&R strategies in force in each country. A drug’s inclusion in a national formulary may otherwise be impeded - potentially impacting overall sales.
Cost containment and healthcare coverage rank as key concerns for payers, and pharma companies will need to be aware of the implications these concerns have on market accessibility, sales and return on investment if they are to succeed.
This report provides an analysis of the latest developments in P&R in the key Asia Pacific markets. It offers an insight in the opportunities and barriers for branded pharma companies looking to enter these markets and identifies key trends shaping overall market evolution.
A RARE HERB OF MADHYA PRADESH HAVING PIVOTAL IMPORTANCE IN FOLK REMEDIES
Kotlaiya is an important medicinal plant of the ancient system of healing. It is type of kantkāri, a medicinal plant widely used in Āyurveda in the treatment of respiratory diseases. It has been described as white variety of kantkārī. The present paper reviews the pharmacognosy, phytochemistry and traditional uses of the herb.
Insulin antidiabetics - Return to injections alternative delivery methods fall by the wayside
Alternative delivery methods under development have so far failed to live up to expectations. In many cases the technical difficulties associated with the delivery technique have not been overcome, leading to a return to injection based therapies. Big Pharma have all but exited the development of new insulin therapies leaving the field to small niche players.
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