Labeling Comprehensive Drug

Rx-to-OTC switch in Japan has for a long time followed the principle—safety first and efficacy second (53). For this reason, a lower dose is often switched. Label comprehension is not a big issue for Japanese OTC products because OTC products are sold primarily in the pharmacy and a lot of graphics and cartoons are used to communicate warnings and directions of use. Rx-to-OTC switches are usually cf low profile in Japan. The reason is that physicians seldom support and advocate the switch. Because physicians both prescribe and dispense prescription drugs, the switch will decrease their business. There are a couple of other reasons for poor performance of some of the Rx-to-OTC switches. Consumers view OTC products as less effective because of lower dose and less safe because of warnings listed on the label and in advertising. Moreover, co-pay for prescription drugs used to be... 

In-vitro models can provide preliminary insights into some pharmacodynamic aspects. For example, cultured Caco 2 cell lines (derived from a human colorectal carcinoma) may be used to simulate intestinal absorption behaviour, while cultured hepatic cell lines are available for metabolic studies. However, a comprehensive understanding of the pharmacokinetic effects vfill require the use of in-vivo animal studies, where the drug levels in various tissues can be measured after different dosages and time intervals. Radioactively labelled drugs (carbon-14) may be used to facilitate detection. Animal model studies of human biopharmaceutical products may be compromised by immune responses that would not be expected when actually treating human subjects. 

The chemical structures and biological activities of hundreds of opioid analgesics derived from the prototype opioid drug morphine are most comprehensively described in two books published in 1986, one entitled Opioid Analgesics, Chemistry and Receptors by Casy and Parfitt [1] and the other entitled Opiates by Lenz et al. [2]. Follow-up articles include those by Casy in 1989, entitled Opioid Receptors and their Ligands Recent Developments [3] which also includes sections on opioid peptides, affinity labelling and opioid receptor subtypes Rees and Hunter in 1990 [4] covering the... 

A label-free comprehensive platform for functional evaluation of endogenous receptors. Assay and Drug Development Technologies, 4 (5), 609-619. 

This Instrument defines in a more comprehensive manner, the expressions and the rules to be adopted by the labels and package insert accompanying drugs for human use. At the same time it... 

The intended uses of healthcare antiseptic products were carefully evaluated and redefined as necessary to reflect the current thinking of the FDA. These uses are based on the recommendations of the Antimicrobial I Panel, comments submitted to the TFM, and the FDA s own regulatory experiences with NDAs. The TFM monograph for healthcare antiseptic drug products provides one of the most comprehensive and detailed attempts at describing protocols and efficacy requirements of products intended for use by healthcare professionals. The pre-clinical efficacy requirements include an assessment of the in vitro spectrum of activity and time-kill kinetic studies. The clinical assessment requires conduct of the clinical simulation studies either for the healthcare personnel handwash, surgical hand scrub, or patient preoperative skin prepping indications. The studies performed are dictated by the indications desired on the product label. 

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