Prospective harmonization

To include two additional concepts of harmonization prospective— to avoid conflicts among pharmacopeial standards before they occur, and retrospective—to resolve conflicts among existing pharmacopeial standards. 

Articulating the three concepts for harmonization was particularly important. Prospective and retrospective clarify the distinction between work required to avoid conflict when establishing standards for pharmacopeial articles for which standards do not exist, or where few standards exist among the pharmacopeias, from work required to reconcile differences among well-established standards for articles that may have been in the pharmacopeias for considerable time. Prospective harmonization was inaugurated for biotechnology-derived products. Retrospective harmonization focused on pharmaceutical excipients and analytical tests and methods. Forward harmonization expresses a philosophy and environment for harmonization consistent with advances in pharmaceutical analysis. 

Prospective harmonization is particularly successful when dealing with biotechnology-derived products [14,15] because only a few manufacturers are involved. There should be no reason for the pharmacopoeias to arrive at different standards proposed for any particular medicine. This is in stark contrast to the situation where many manufacturers of drugs are no longer covered by patent protection. There is no possibility of harmonization of the some 4000 monographs for individual substances and preparations. 

Harmonization may be carried out retrospectively for existing monographs or chapters or prospectively for new monographs or chapters. The three pharmacopeias have a commitment to respect the agreed working procedures and the associated time deadlines as an essential part of the harmonization procedure. The PDG has defined harmonization of a pharmacopeial monograph or general chapter as follows ... 

Whether the monitoring of endoxifen plasma concentrations in breast cancer patients would constitute a valid approach to optimize individual dosage and improve treatment efficacy is under scrutiny and remains to be demonstrated. In that purpose large prospective studies relating endoxifen plasma levels to clinical outcomes are as yet needed. In this perspective, it is critical to settle analytical and selectivity discrepancies between methods and laboratories and to ensure reproducible quantification results between laboratories. These concerted harmonization efforts can be carried out within the frame of an international external quality control program, which as yet, remains to be organized. 

Ashby J. 1986. The prospects for a simplified and internationally harmonized approach to the detection of possible human carcinogens and mutagens. Mutagenesis 1 3-16. 

In 1970 the first report of the molecular hydrogen laser opened up a decade of activity in VUV laser development, which included the appearance of rare gas excimer and exciplex lasers and the achievement of tunable coherent radiation in the Lyman-a region via harmonic generation. The surge of activity in the development of VUV lasers arose in part from the uniqueness of the VUV region, in part from the ultimate interest in X-ray lasers and, from our perspective, from the exciting prospects in spectroscopy and molecular dynamics promised by narrow linewidth, tunable, high-power VUV laser pulses for state-selective studies. Here we review the principles on which VUV lasers are based. 

There are many obstacles to this revolution. Innovation is not a linear process, and the science simply may not work. It may work but take too long and be too expensive for the people who fund it. Political pressure on the drug companies to set lower prices may mean that resources are not available. In most areas of the pharmaceutical industry, there is progress towards harmonization, and the prospects for reasonable policies are encouraging. In the area of pricing and reimbursement, there is conflict. On almost any scenario, there is a mismatch between what the drug companies are hoping to deliver and what the paymasters —... 

Taylor SL (2000). Prospects for the future emerging problems-food allergens. ALNORM 99/15. Presented at the Conference on International Food Trade Beyond 222 Science-Based Decisions, Harmonization, Equivalence and Mutual Recognition, Melbourne, Australia, Oct. 

Birchall, M.A., Schock, E., Harmon, B. V., and Gobe, G., Apoptosis, mitosis, PCNA and bcl-2 in normal, leukoplakic and malignant epithelia of the human oral cavity prospective, in vivo study, Oral Oncol, 33 (6), 419, 1997. 

Clark PE, Hall MC, Borden LS Jr, Miller AA, Hu JJ, Lee WR, Stindt D, D Agostino R Jr, Lovato J, Harmon M, Torti FM (2006) Phase I-B prospective dose escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy. Urology 67 1257-1261... 

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