Regional Export Expansion: Hearings, Ninetieth Congress, First [-second] Session, on Potentials and Problems of Developing Small Business Regional Export Industries and Institutions Over the Next Decade, Volume 7

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Page 2994 - Because of the high potency of the drug and the variability of its potential to cause adverse reactions, the following are strongly recommended: 1) the lowest possible effective dose for the individual patient should be prescribed. Increased dosage tends to increase adverse...
Page 2778 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have...
Page 2899 - ... substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling...
Page 2820 - Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested...
Page 2997 - ... generally do not increase the efficacy of the drug. Duration of treatment with INDOCIN must be individualized, based on the variable activity of the disease. The usual starting dose is 25 mg bid or tid for active stages of moderate rheumatoid arthritis. If the starting dosage is well tolerated, increase by 25 mg at about weekly intervals until a satisfactory response is obtained or until the total daily dose of 1 50 to 200 mg is reached.
Page 3009 - Man, the knowledge that the remedies act in this way is one of the most recent acquirements of medicine. . . . Few can now be found who will deny that the success which attended the complex prescriptions, and most of the dietetic remedies of the la-st generation, was due mainly, if not entirely, to the play of faith and suggestion. The salient feature of the medicine of today is that these psychical factors are no longer allowed to play their part unwittingly, but are themselves becoming the subject...
Page 3014 - They ask — and it must be confessed that they ask with reason — what pledge can be afforded them, that the boasted remedies of the present day will not, like their predecessors, fall into disrepute, and, in their turn, serve only as humiliating memorials of the credulity and infatuation of the physicians who commended and prescribed them ?
Page 3017 - Now that I once more approach the riddle of suggestion after having kept away from it for some 30 years, I find there is no change in the situation," and that it is necessary to formulate a concept of suggestion correctly and limit its extended use. He goes on, "But there has been no explanation of the nature of suggestion, that is, the conditions under which influence without logical foundation takes place.
Page 2941 - For more detailed information, consult your MSD representative or see full prescribing information. Merck Sharp & Dohme. Division of Merck & Co INC West Point Pa 19486 MSD...
Page 2970 - Precautions to check the actual package yield produced from a batch of the drug with the theoretical yield. This should include a description of the accounting for such items as discards, breakage, etc., and the criteria used in accepting or rejecting batches of drugs in the event of an unexplained discrepancy.

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