The first rumblings for US drug legislation began after the Civil War, which had spurred the separation of drug manufacturers from drug prescribers and drug dispensers. This was the time of the traveling medicine shows selling dangerous, addictive or just non-sense patent medicines. Today's pharmaceutical companies got their start in the apothecary shops of that time, but still, most drugs were imported from Europe. In fact the U.S was a dumping ground for substandard and contaminated drugs.
It's been said that a pharmaceutical company loses $1 million for every day of delay during clinical research and development. This is a theoretical cost related to the dramatic reduction in sales when a drug product loses patent protection and becomes subject to generic competition. Nevertheless, the fact remains that, as clinical research professionals, we must be excellent managers, not just of others, but of our own time, as well.
During those confusing and wondrous years, when a young man ponders his career choices, my dream was to become a singer-songwriter. Blowing my hard-earned profits from an after school job on a multi-track recorder, I spent precious study time mixing down vocal, guitar and synthesizer tracks composing what would surely become the next big platinum album.
On May 9th, 1997, the US Food and Drug Administration (FDA) published in the FEDERAL REGISTER (vol. 62, No 90), the latest rendition of the International Conference on Harmonization (ICH) Guideline covering the conduct of clinical research studies in the seven member nations. Guidelines represent the agency's current thinking on Good Clinical Practices, but do not bind the FDA or the public. However, most clinical research studies are now being conducted in compliance with this guideline, especially if the results might be used for an international regulatory submission. Here are the major differences.
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The first rumblings for US drug legislation began after the Civil War, which had spurred the separation of drug manufacturers from drug prescribers and drug dispensers. This was the time of the traveling medicine shows selling dangerous, addictive or just non-sense patent medicines. Today's pharmaceutical companies got their start in the apothecary shops of that time, but still, most drugs were imported from Europe. In fact the U.S was a dumping ground for substandard and contaminated drugs.
It's been said that a pharmaceutical company loses $1 million for every day of delay during clinical research and development. This is a theoretical cost related to the dramatic reduction in sales when a drug product loses patent protection and becomes subject to generic competition. Nevertheless, the fact remains that, as clinical research professionals, we must be excellent managers, not just of others, but of our own time, as well.
During those confusing and wondrous years, when a young man ponders his career choices, my dream was to become a singer-songwriter. Blowing my hard-earned profits from an after school job on a multi-track recorder, I spent precious study time mixing down vocal, guitar and synthesizer tracks composing what would surely become the next big platinum album.
On May 9th, 1997, the US Food and Drug Administration (FDA) published in the FEDERAL REGISTER (vol. 62, No 90), the latest rendition of the International Conference on Harmonization (ICH) Guideline covering the conduct of clinical research studies in the seven member nations. Guidelines represent the agency's current thinking on Good Clinical Practices, but do not bind the FDA or the public. However, most clinical research studies are now being conducted in compliance with this guideline, especially if the results might be used for an international regulatory submission. Here are the major differences. 