Establishing Bioequivalence in Virtual Space: Are We Really There?

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by: Shriram M. Pathak & Amitava Mitra

pathak-shriram_headshotmitro-amitava_headshotEstablishing bioequivalence is the most crucial component of a generic drug application, which is indeed a time consuming and costly process. Hence, assessing in vivo equivalence of drug products virtually has always been a subject of great interest for pharmaceutical scientists. In recent times, advancements in in-silico modeling techniques have enhanced the ability of scientists to predict comparable in vivo performance of the test product with that of the innovator product. Continue reading

Save Lives: Support the 21st Century Cures Act to Bolster Medical Research

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by: rachel weissman

A strong majority of photo_raAmericans (91%) say it is important to develop better medicines for conditions we currently treat, according to a recent public opinion survey commissioned by Research!America. To achieve this, we need scientists; we need resources; and we need sustained support. Both the public and private sectors have crucial roles to play, but over the past decade the federal commitment to research has wavered. The purchasing power of the National Institutes of Health (NIH) is just three-quarters of what it was a decade ago. The percentage of grants approved to receiving funding from the NIH have been cut in half compared to 15 years ago; and the average age for an individual’s first NIH grant is 42. Fortunately, champions in Congress are seeking to change this landscape. Continue reading

Celebrate the Best Kept Secret in Health Care: Pharmaceutical Scientists and Pharmacists

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by: Luc Besançon

Pharmaceutical scientists alr_pw35besancon03fb_8050nd pharmacists are key in translating scientific advances into better health. Some medicines, such as antibiotics, may become obsolete in the future, and there are still no treatments for certain diseases. This is where pharmaceutical scientists and pharmacists play a vital part, developing innovative new medicines and ensuring their proper use. The International Pharmaceutical Federation (FIP) is in a unique position to marry up these activities. Continue reading

Things are Leukin Up: Stimulating IL-12 Using Immunotherapeutic Cancer Vaccines

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by: theresa el-murr

Immunotherapel-murr-headshoteutic vaccines have emerged as a novel approach to treat cancer by upregulating the immune system to respond to tumor cells by various mechanisms including the stimulation of the adaptive and innate immune system. This stimulation is followed by cytokine secretion that leads to the recruitment and development of our body’s immune cells. One such cytokine, Interleukin-12, is an inflammatory cytokine that is secreted when it comes in contact with cancer cells and it activates key aspects of our immune system’s defenses. For example, IL-12 activates both T-lymphocytes (T-cells) of the adaptive system and natural killer cells of innate immunity. In addition, the presence of IL-12 induces the secretion of IFN-γ by natural killer (NK) cells and T-cells. By triggering the immune system to fight, the stimulation of IL-12 is a necessary step in the success of tumor immunotherapy. Continue reading

Will Prescription Heroin Solve Drug Addiction?

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By: Aniruddha M. Railkar

Quick Perspective Graphic

Quick Perspective on Canada has just approved prescription heroin

The Canadian government approved prescription heroin to treat drug addiction. The lead physician of a drug addiction treatment clinic says it cuts down on criminal activity. I feel cautiously positive about this. If conventional treatments have failed, perhaps something unconventional might work. This approach is used in the U.S. and eight European Union countries. However, the article does not cite results from those countries. Since the treatment is provided in a controlled environment, in addition to reducing criminal activity, it could also reduce transmission of AIDS. More studies are needed to prove effectiveness of this treatment.

Aniruddha (Ani) M. Railkar is director, CMC, at Tarsa Therapeutics. He is the current chair of the PHILADELPHIA PHARMACEUTICAL FORUM discussion group.