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The juice may be ad- ple unit does not meet the criteria set justed by the addition of the optional forth in the standards order coumadin 2mg fast delivery arrhythmia blogs. The juice may prepared from unconcentrated buy coumadin 5 mg free shipping hypertension remedies, undi- have been concentrated and later re- luted liquid extracted from mature constituted generic coumadin 5 mg otc arrhythmia light headed. When prepared from con- lemons; or (2) if the food is prepared centrated lemon juice, the finished from unconcentrated, undiluted liquid food contains not less than 6 percent, extracted from mature lemons to by weight, of soluble solids taken as which concentrated lemon juice is the refractometric sucrose value (of added to adjust acidity as provided for the filtrate), corrected to 20 °C, but un- in paragraph (a)(1) of this section. The words "from con- which is incorporated by reference, and centrate" or "reconstituted" shall be has a titratable acidity content of not shown in letters not less than one-half less than 4. The food may con- general method for fill of container tain one or any combination of the safe prescribed in §130. When sealed in a (2) Compliance is determined as spec- container to be held at ambient tem- ified in §146. The optional ment of substandard fill specified in safe and suitable ingredients referred §130. The lemon ysis of the Association of Official Ana- juice ingredients may be treated by lytical Chemists," 13th Ed. It For the purposes of this section, lemon may contain one or more safe and suit- juice is the undiluted juice expressed able dispersing ingredients serving the from mature lemons of an acid variety; function of distributing the lemon oil and concentrated lemon juice is lemon throughout the food. It may also con- juice from which part of the water has tain one or more safe and suitable been removed. Each of the in- lished pursuant to section 409 of the gredients used in the food shall be de- act. Grape- (d) If an optional thickening or dis- fruit juice is the unfermented juice, in- persing ingredient referred to in para- tended for direct consumption, ob- graph (a) of this section is used, the tained by mechanical process from label shall bear the statement "lll sound, mature grapefruit (Citrus added" or "with added lll", the paradisi Macfadyen) from which seeds blank being filled in with the common and peel (except embryonic seeds and name of the thickening or dispersing small fragments of seeds and peel agent used. Such statement shall be set which cannot be separated by good forth on the label with such promi- manufacturing practice) and excess nence and conspicuousness as to render pulp are removed and to which may be it likely to be read and understood by added not more than 10 percent by vol- the ordinary individual under cus- ume of the unfermented juice obtained tomary conditions of purchase. The (e) Frozen concentrate for artificially juice may be adjusted by the addition sweetened lemonade is labeled to con- of the optional concentrated grapefruit form to the labeling requirements pre- juice ingredients specified in paragraph scribed for foods which purport to be or (a)(2) of this section, but the quantity are represented for special dietary use of such concentrated grapefruit juice by regulations promulgated pursuant ingredient added shall not contribute to section 403(j) of the act. If the and standard of identity prescribed for grapefruit juice is prepared from con- frozen concentrate for lemonade by centrate, such sweeteners, in liquid §146. When juice, or any such juice in concentrated prepared from concentrated grapefruit form, or with any other color additive juice, exclusive of added sweeteners, ingredient suitable for use in food, in- the finished food contains not less than cluding artificial coloring, used in con- 10 percent, by weight, of soluble solids formity with regulations established taken as the refractometric sucrose pursuant to section 721 of the Federal value (of the filtrate), corrected to 20 Food, Drug, and Cosmetic Act. I (4–1–10 Edition) obtained sucrose value by the first water and/or grapefruit juice; or (2) if method prescribed in "Correction of the food is prepared from grapefuit Refractometer Sucrose Readings for juice from concentrate and grapefruit Citric Acid Content for Lemonade," by juice. The words "from concentrate" Yeatman, Senzel, and Springer, "Jour- shall be shown in letters not less than nal of the Association of Official Ana- one-half the height of the letters in the lytical Chemists," vol. Each of the in- codeloflfederallregulations/ gredients used in the food shall be de- ibrllocations. The food may con- clared on the label as required by the tain one or any combination of the op- applicable sections of parts 101 and 130 tional ingredients specified in para- of this chapter. Grapefruit (b) [Reserved] juice, as defined in this paragraph, may (c) Fill of container. When except when the food is frozen, is not sealed in a container to be held at am- less than 90 percent of the total capac- bient temperatures, it is so processed ity of the container as determined by by heat, before or after sealing, as to the general method for fill of container prevent spoilage. The optional (2) Compliance is determined as spec- ingredients referred to in paragraph ified in §146. Seeds added to adjust soluble solids as pro- (except embryonic seeds and small vided for in paragraph (a)(1) of this sec- fragments of seeds that cannot be sepa- tion. The name "orange juice" may ther before or after such heat treat- be preceded on the label by the varietal ment, all or a part of the product may name of the oranges used, and if the or- be frozen. The finished pasteurized or- anges grew in a single State, the name ange juice contains not less than 10. If the food is reticulata or Citrus reticulata hybrids filled into containers and preserved by (except that this limitation shall not freezing, the label shall bear the name apply to the hybrid species described in "Frozen pasteurized orange juice". Seeds (except embryonic words "pasteurized" or "frozen pas- seeds and small fragments of seeds that teurized" shall be shown on labels in cannot be separated by good manufac- letters not less than one-half the turing practice) are removed, and pulp and orange oil may be adjusted in ac- height of the letters in the words "or- cordance with good manufacturing ange juice". If the adjustment involves the (2) If the pasteurized orange juice is addition of pulp, then such pulp shall filled into containers and refrigerated, not be of the washed or spent type. The the label shall bear the name of the solids may be adjusted by the addition food, "chilled pasteurized orange of one or more of the optional con- juice". If it does not purport to be ei- centrated orange juice ingredients ther canned orange juice or frozen pas- specified in paragraph (b) of this sec- teurized orange juice, the word tion. One or more of the optional "chilled" may be omitted from the sweetening ingredients listed in para- name. The words "pasteurized" or graph (c) of this section may be added "chilled pasteurized" shall be shown in in a quantity reasonably necessary to letters not less than one-half the raise the Brix or the Brix-acid ratio to height of the letters in the words "or- any point within the normal range usu- ange juice". I (4–1–10 Edition) statement "prepared in part from con- this section may be added, in a quan- centrated orange juice" or "with added tity reasonably necessary to raise the concentrated orange juice" or "con- Brix or the Brix-acid ratio to any point centrated orange juice added". However, for the purpose of this the Brix hydrometer reading to the section, the name "sweetener" may be grams of anhydrous citric acid per 100 used in lieu of the specific name or milliliters of juice is not less than 9 to names of the sweetening ingredients. All the words in the follow the name of the food, without name shall appear in the same size, intervening written, printed, or graph- color, and style of type and on the ic matter. Each of the in- the food is not sold under refrigeration gredients used in the food shall be de- clared on the label as required by the and if it does not purport to be chilled applicable sections of parts 101 and 130 pasteurized orange juice or frozen pas- of this chapter. How- unfermented juice obtained from ma- ever, for the purpose of this section, ture oranges of the species Citrus the name "sweetener" may be used in reticulata or Citrus reticulata hybrids lieu of the specific name or names of (except that this limitation shall not the sweetening ingredients. Seeds (except embryonic pears on the label so conspicuously as seeds and small fragments of seeds that to be easily seen under customary con- cannot be separated by good manufac- ditions of purchase, the statement turing practice) are removed. Orange specified in this section for naming the oil and pulp may be adjusted in accord- optional ingredients used shall imme- ance with good manufacturing prac- diately and conspicuously precede or tice. The adjustment of pulp referred to follow the name of the food, without in this paragraph does not permit the intervening written, printed, or graph- addition of washed or spent pulp. To such mixture gredients used in the food shall be de- may be added orange juice as defined in clared on the label as required by the §146. The finished orange from the juice of mature oranges as juice from concentrate contains not provided in §146. In its preparation, (c) The name of the food is "Orange seeds (except embryonic seeds and juice from concentrate". The words small fragments of seeds that cannot "from concentrate" shall be shown in be separated by good manufacturing letters not less than one-half the practice) and excess pulp are removed, height of the letters in the words "or- and a properly prepared water extract ange juice". Orange oil, orange pulp, orange centrate contains any optional sweet- essence (obtained from orange juice), ening ingredient as listed in paragraph orange juice and other orange juice (b) of this section, whether added di- concentrate as provided in this section rectly as such or indirectly as an added or concentrated orange juice for manu- ingredient of any orange juice product facturing provided in §146. I (4–1–10 Edition) added in single strength or con- "frozen concentrated orange juice, centrated form prior to concentration lll plus 1" or "frozen orange juice of the Citrus sinensis juice, or in con- concentrate, lll plus 1", the blank centrated form during adjustment of being filled in with the whole number the composition of the finished food. However, where the label bears aurantium, or both, shall not exceed, on directions for making 1 quart of orange a single-strength basis, the 10 percent juice from concentrate (or multiples of maximum for Citrus reticulata and the 5 a quart), the blank in the name may be percent maximum for Citrus aurantium filled in with a mixed number; for ex- prescribed by this paragraph. Any of ample, "frozen orange juice con- the ingredients of the finished con- centrate, 41⁄3 plus 1". For containers centrate may have been so treated by larger than 1 pint, the dilution ratio in heat as to reduce substantially the en- the name may be replaced by the con- zymatic activity and the number of centration of orange juice soluble sol- viable microorganisms. The finished ids in degrees Brix; for example, a 62° food is of such concentration that when Brix concentrate in 31⁄2-gallon cans diluted according to label directions may be named on the label "frozen con- the diluted article will contain not less centrated orange juice, 62° Brix". The dilution ratio shall be ditions of purchase, the statements not less than 3 plus 1.

Editorial comments • This drug is listed without details in the Physician’s Desk Reference buy coumadin overnight delivery blood pressure apparatus, 54th edition discount coumadin 5mg with mastercard blood pressure normal teenager, 2000 order 2mg coumadin overnight delivery hypertension complications. Mechanism of action: Blocks acetylcholine effects at muscarinic receptors throughout the body. Mechanism of action: Binds to opiate receptors and blocks asce- nding pain pathways. Contraindications: Hypersensitivity to oxycodone or other nar- cotics of the same chemical class, respiratory depression, severe bronchial asthma, paralytic ileus. Warnings/precautions • Use with caution in patients with: head injury with increased intracranial pressure, serious alcoholism, prostatic hypertro- phy, chronic pulmonary disease, severe liver or kidney disease, disorders of biliary tract, supraventricular tachycardia, history of convulsion disorder, postoperative patients with pulmonary disease. If nausea and vomiting persist, it may be necessary to administer an antiemetic, eg, droperidol or prochlorperazine. Mechanism of action: Binds to opiate receptors and blocks ascending pain pathways. Contraindications: Hypersensitivity to narcotics of the same chemical class, paralytic ileus, acute asthmatic attack, severe respiratory depression, upper urinary tract obstruc- tion, pulmonary edema secondary to chemical respiratory irritant. If nausea and vomiting persist, it may be necessary to administer an antiemetic, eg, droperidol or prochlorperazine. Mechanism of action: Oxytocic action: stimulates contractions of uterine smooth muscle. Contraindications: Hypersensitivity to oxytocin, fetal distress, severe toxemia, total placenta previa, anticipated nonvaginal delivery (invasive cervical cancer), prolapse, active herpes genitalis, unfavorable fetal position, hyperactive uterus, contraindicated vagi- nal delivery, women with four or more previous deliveries. Clinically important drug interactions: Drugs that increase effects/ toxicity of oxytocin: sympathomimetics, vasoconstrictors, cyclo- propane, thiopental. Parameters to monitor • Fetal maturity, presentation, adequacy of pelvis before admin- istration of oxytocin for labor induction. Mechanism of action: Inhibits normal reorganization of micro- tubules required for mitosis, thus inhibiting tumor cell division. Note: This course of treatment should not be repeated unless the neutrophil count is at least 1500 mm3 or platelet count is 100,000/mm3. Contraindications: Contraindicated in patients with hypersensi- tivity to paclitaxel or polyoxyethylated castor oil (excipient), neutrophil count <1500 mm3, pregnancy. Advice to patient: Use two forms of birth control including hor- monal and barrier methods. Adverse reactions • Common: nausea, vomiting, diarrhea, alopecia, myalgia, phlebitis, erythema at site of injection. Clinically important drug interactions • Cisplatin increases the effects/toxicity of paclitaxel. Parameters to monitor • Monitor vital signs frequently, particularly during the 24 hours of infusion. It is recommended that all patients should receive one of the following prior to administration of paclitaxel: diphenhydramine, an H2 blocker, dexamethasone. Infusion should be stopped if patient mani- fests dyspnea, chest pain, hypotension. Paclitaxel is active in breast cancer, ovarian cancer, non-small cell lung cancer, and head and neck cancers. In combina- tion with cisplatin or carboplatin, it is the drug of choice for ovarian cancer. It is also approved for adjuvant chemotherapy for lymph node-positive breast cancer. Mechanism of action: Blocks nicotinic acetylcholine receptors at neuromuscular junction, resulting in skeletal muscle relax- ation and paralysis. Contraindications: Hypersensitivity to pancuronium and chem- ically related drugs. Editorial comments • This drug is listed without details in the Physician’s Desk Ref- erence, 54th edition, 2000. Editorial comments • Alternative drugs for amebiasis include amikacin, gentamicin, kanamycin, neomycin, streptomycin, tobramycin. Advice to patient • Avoid driving and other activities requiring mental alertness or that are potentially dangerous until response to drug is known. Adverse reactions • Common: drowsiness, nausea, diarrhea, constipation, dry mouth, male sexual dysfunction, tremor. Avoid administration if baseline liver enzymes are abnormal and discontinue immedi- ately if abnormalities develop during therapy. If therapy is discontinued and then resumed, baseline liver enzymes and continuous monitoring are required. Mechanism of action: Wilson’s disease: chelates copper into a complex readily excreted by the kidneys, thus decreasing blood and tissue levels; decreases circulating IgM rheumatoid factor and depresses T-cell activity; these result in suppression of active inflammation. Cystinurea: forms a soluble complex with cystine, preventing formation of cystine calculi. Adjustment of dosage • Kidney disease: Creatinine clearance <50 mL/min: avoid use. Onset of Action Duration May be delayed for 2–3 mo in No data treatment for rheumatoid arthritis Food: Should be taken 1 hour before or 2 hours after meals. Pyridoxine supplementation with doses of 25 mg/d is recom- mended in patients with Wilson’s disease or cystinuria receiving pencillamine. Warnings/precautions • Use with caution in patients with history of aplastic anemia due to penicillin, patients requiring surgery; kidney disease; elderly. These include shellfish, liver, choco- late, broccoli, foods enriched with copper (cereals). If drinking water contains >100 µg/L of copper, patient should take only demineralized or distilled water. Advice to patient • Use two forms of birth control including hormonal and barrier methods. Adverse reactions • Common: anorexia, nausea, vomiting, abdominal pain, taste disorders, skin rash. It should be administered only by physicians familiar with all poten- tially toxic reactions as well as proper monitoring of patients receiving the drug. Susceptible organisms in vivo: Beta-hemolytic streptococci, viridans streptococci, Streptococcus pneumoniae (increasing lack of susceptibility), Enterococcus faecalis, Neisseria menin- gitidis, Treponema pallidum (syphilis), Listeria monocytogenes. Unusual infections: Corynebacterium diphtheriae, Bacillus anthracis, Clostridium sp, Erisipelothrix rhusiopathiae, Actino- myces, Streptococcus bovis, Pasteurella multicoda, Strepto- bacillus moniliformis, Spirillum minus. Warnings/precautions • Allergic reactions are more likely to occur in patients with asthma, hay fever, allergy to cephalosporins, history of allergy for penicillin. Consider skin testing with major and minor anti- genic components of penicillin in such patients to assess the possibility of a hypersensitivity reaction. If patient is given the drug parenterally, observe for at least 20 minutes for pos- sible anaphylactic reaction. Advice to patient • If you are receiving an oral contraceptive, use an alternative method of birth control. Clinically important drug interactions • Drug that increases effects/toxicity of penicillins: probenecid. In neurosyphilis, penicillin is the only recommended drug; therefore, patients with allergy to penicillin are usually tested and desensitized if needed.

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When the task was described as an intelligence test and the confederate introduced as highly intelligent cheap coumadin line hypertension food, the mean movement score of subjects tended to shift away from that of the confederate buy coumadin pills in toronto blood pressure high heart rate low. In another study buy discount coumadin 5 mg on line heart attack 19 years old, Mausner (97) created success and failure for confederates participating with undergraduate students in twenty trials of using a stylus to reproduce the length of a slot of light. A greater degree of shift occurred when the critical subject judged with -238- a confederate perceived as successful on the prior task. A similar design was used by Mausner and Bloch (100), with results corroborating those by Mausner (99). Raven and French (109) varied the status or prestige of a person under two conditions: the person initiating the influence was seen either (it) as elected by the group and having its support or (b) as not elected or supported by the group. The effect of acquaintances or strangers on the expression of attitudes has been investigated by Lambert and Lowry (81). Male undergraduates filled out comparable forms of the F scale alone, in groups of five without discussion and in groups of five after discussion. Some of the groups were composed of "high acquaintances," and others included individuals who were relatively unacquainted. Results show a reduction in variability of scores in the case of together and discussion conditions for high acquaintance subjects, with low acquaintance subjects apparently unaffected by either pressure condition. Harvey, Kelley, and Shapiro (57) have reported a significant shift toward lower self ratings under influence created by acquaintances and by strangers (see above). Kidd (76) created and controlled the degree of acquaintance by restricting the duration of prior participation to 1, 2, or 3 hr. To evaluate the effect of minority group membership on susceptibility, Bray (23) used Gentiles as critical subjects, whereas the confederates were presented as Negro, Jew, and Gentile. Since results are contradictory, only replication and refinement will make it possible to comprehend the relationships. Festinger and Thibaut (41) found for discussion of football but not juvenile delinquency significantly greater readiness of homogeneous groups to shift opinion as a function of receiving notes from others. Gerard (48) created homogeneity and heterogeneity similarly for discussion of federal aid to education, and found changes in opinion to be unrelated to the homogeneity-heterogeneity dimension. Festinger, Gerard, Hymovitch, Kelley, and Raven (40) report no differences in opinion change among groups told that "experts" were -239- present compared with control groups. Since there were no influence attempts directly traceable to "experts," this variation appears to have been a manipulation of homogeneity-heterogeneity in the proper sense rather than a variation in the prestige dimension (see above). Differences in susceptibility are related to characteristics of the persons creating the influence. Age differences found include greater influence exerted on children by children than by adults, and on younger children by older children than on older by younger children. Several studies have reported greater susceptibility to pressures created by acquaintances than by strangers. Greater influences are exerted when the other person has a higher status than the subject. Uniform results have not been obtained from experiments designed to evaluate the influence of homogeneity-heterogeneity among members. Mouton, Blake, and Olmstead (103) found that influence was significantly greater when college subjects disclosed their personal identity than when conditions permitted anonymity (see above). Reduced susceptibility to pressures under conditions of anonymity has been clearly demonstrated; this explains use of the secret ballot as a basic instrument of personal expression. Of two studies varying the personal commitment factor, one by Deutsch and Gerard (35) introduced three variations. The highest frequency of shifting occurred when recording was not required, with lowest frequencies resulting when the responses were recorded, personally signed, and given to the experimenter. Fisher, Rubinstein, and Freeman (43) used a tachistoscopic presentation for the task of indicating the number of dots exposed on a trial-by-trial basis. The conditions were: first, judging without partners; second, judging only after the partner; third and fourth, judging both prior to and following the partner. Although subjects did not shift significantly for any one trial, judgments given prior to the confederate steadily increased. An individual who makes a definite commitment prior to being subjected to pressures resists and maintains his position more strongly. The degree of public commitment is positively related to the degree of resistance to influence. Variations in relations among members that have been studied are perceived independence on a partner to attain a goal, and perceived success jointly with the partner in working toward a goal. Approximately half the subjects in the study by Bovard (22) participated in "leadercentered" classes, i. Individual judgments showed significant convergence toward the announced group norm in all groups. Both the dispersion of initial judgments and degree of convergence after the announced group norm and during the last week of the course were significantly greater for group-centered classes. Maier and Solem (94) arranged for half the groups to have leaders instructed to encourage member participation, and the other half, observers free -241- to participate only in member roles. After an eight-minute discussion of the Maier Horse Trading Problem, groups with leaders significantly increased their per cent of correct answers. Preston and Heintz (108) had students first give individual rankings of the names of twelve prominent men for their desirability as President of the United States; next, a group ranking of the twelve names in four- to five-person groups having either participatory or supervisory leaders; and a final individual ranking. Final individual rankings of participatory leaders and followers correlated significantly higher with the group rankings. There also was more shifting from initial to final rankings for those working under participatory leaders. Hare (56) replicated the experiment by Preston and Heintz (108), and reports similar findings. Berkowitz (12) had partners send and decode messages transmitted by telegraph keys to each other. Subjects who believed they would gain a prize worked fastest on improvement trials; those who believed only their partners would gain a prize worked faster than subjects who knew nothing of the prize. Facilitation from perceived dependency on another for attaining a goal constitutes a significant influence factor. Kidd and Campbell (77) varied reported success of the group on a preliminary anagram task. Members who had had prior experience of success with one another conformed to a significantly greater degree to the attributed group norm for a later task. This may be because individual differences become more evident and greater possibilities exist for the exertion of pressure. Findings also indicate that greater pressure exists when one member recognizes that another member is dependent on his performance for success, and that greater susceptibility occurs among members who have shared success. Cohesion and Valuation of Group Membership Cohesion is a variable in the group situation. Both subjects wrote a story about three sets of pictures, differing primarily in details, and then discussed them with each other.

For example purchase genuine coumadin online blood pressure blurry vision, if the data indicate that substandard medicines are the main drug quality problem in one part of the world discount coumadin 2 mg blood pressure medication irbesartan, then better regula- tion of manufacturers can do much to improve the problem order 1mg coumadin arteria inflamada del corazon. Similarly, if it becomes clear that a country has a problem with diverted medicines in commerce, then some of the distribution chain improvements presented in Chapter 5 would enhance the national drug safety program. Consistent use of this rapid alert form and eventually linking it to national pharmaco- vigilance systems would advance international discourse and give a more nuanced understanding of the extent and type of falsifed, substandard, and unregistered medicines that circulate around the world. Countering the Problem of Falsified and Substandard Drugs 111 Copyright © National Academy of Sciences. Countering the Problem of Falsified and Substandard Drugs 112 Copyright © National Academy of Sciences. Countering the Problem of Falsified and Substandard Drugs 113 Copyright © National Academy of Sciences. Countering the Problem of Falsified and Substandard Drugs 114 Copyright © National Academy of Sciences. Countering the Problem of Falsified and Substandard Drugs 115 Copyright © National Academy of Sciences. Countering the Problem of Falsified and Substandard Drugs 116 Copyright © National Academy of Sciences. Countering the Problem of Falsified and Substandard Drugs 117 Copyright © National Academy of Sciences. Substandard weight variation outside drugs of unknown origin were ampicillin and tetracycline were pharmacopoeial limits substandard. In total, 3% versus 1% contained no active ingredient, 12% versus 4% had too little or too much active ingredient and 35% versus 14% had weight variation outside pharmacopoeial limits. Substandard weight variation outside drugs of unknown origin were ampicillin and tetracycline were pharmacopoeial limits substandard. In total, 3% versus 1% contained no active ingredient, 12% versus 4% had too little or too much active ingredient and 35% versus 14% had weight variation outside pharmacopoeial limits. The highest defcit observed was 48% in two products (co-trimoxazole and benzylpenicillin). As a result, only 8 of 21 products (38%) did not contain the stated dosage of active drug. These cloxacillin [syrup and capsules]) included trimethoprim and quantities of active ingredient sulfamethoxazole tablets. Several antibacterial preparations contained very low quantities of active ingredient (ampicillin and amoxicillin 24% to 40%), and for fve metronidazole suspension preparations, no active ingredient was detected. Okeke and 5 Nigeria Five samples of Three of the fve (60%) capsule Lamikanra ampicillin capsules samples from dispensing points (2001) were found to be of lower quality than the ofcially prescribed standards of pharmaceutical quality. The quality lapses observed were sufcient to bring about determinable diferences in biological availability. The highest defcit observed was 48% in two products (co-trimoxazole and benzylpenicillin). As a result, only 8 of 21 products (38%) did not contain the stated dosage of active drug. These cloxacillin [syrup and capsules]) included trimethoprim and quantities of active ingredient sulfamethoxazole tablets. Several antibacterial preparations contained very low quantities of active ingredient (ampicillin and amoxicillin 24% to 40%), and for fve metronidazole suspension preparations, no active ingredient was detected. Okeke and 5 Nigeria Five samples of Three of the fve (60%) capsule Lamikanra ampicillin capsules samples from dispensing points (2001) were found to be of lower quality than the ofcially prescribed standards of pharmaceutical quality. The quality lapses observed were sufcient to bring about determinable diferences in biological availability. However, four (31%) were (rifampicin and pyrazinamide) substandard, including two (15%) content of active ingredient with low rifampicin content, one (8%) with excessive rifampicin and one (8%) with excessive pyrazinamide. The found to be bioequivalent to the implications for tuberculosis reference administered as loose programs are extremely serious (separate) formulations. Drug quality was Poor initial quality accounted for Reduced level of active Not reported Hogerzeil of 26 benzylpenicillin, measured by level of active problems in injectable ampicillin ingredient (1998) brands of amoxicillin, ampicillin, ingredient as percentage (2/10 central samples failed, 13 essential doxycycline, phenyl- of stated content and by with 87% and 91% content). An drugs methoxypenicillin, and compliance (pass/fail) with aqueous formulation of injectable tetracycline assay standards of the British procaine benzylpenicillin showed Pharmacopoeia. Drug stability moderate instability with 4% was measured by comparing (1% to 6%) loss after 4. However, four (31%) were (rifampicin and pyrazinamide) substandard, including two (15%) content of active ingredient with low rifampicin content, one (8%) with excessive rifampicin and one (8%) with excessive pyrazinamide. The found to be bioequivalent to the implications for tuberculosis reference administered as loose programs are extremely serious (separate) formulations. Drug quality was Poor initial quality accounted for Reduced level of active Not reported Hogerzeil of 26 benzylpenicillin, measured by level of active problems in injectable ampicillin ingredient (1998) brands of amoxicillin, ampicillin, ingredient as percentage (2/10 central samples failed, 13 essential doxycycline, phenyl- of stated content and by with 87% and 91% content). An drugs methoxypenicillin, and compliance (pass/fail) with aqueous formulation of injectable tetracycline assay standards of the British procaine benzylpenicillin showed Pharmacopoeia. Drug stability moderate instability with 4% was measured by comparing (1% to 6%) loss after 4. Ten brands deliberately kept below the of ampicillin were found to be required levels. This was also true of the two brands of co-trimoxazole suspension found to be substandard. Ten other Decomposition is not likely samples outside the British to be a major factor (no large Pharmacopoeia’s range had at amounts of decomposition least 90% or up to 126%. The bioavailability tetracycline content the pharmacopoeia prescribed of substandard product as standards. The power content determined from 48 h urinary of four brands was well below tetracycline excretion was the labeled amount of the signifcantly lower when standard drug. Comparative compared with standard analysis of bioavailability of product both in well-nourished substandard versus standard and in undernourished product indicates that the use subjects. Kelesidis and colleagues use the term counterfeit broadly, the way this report uses the term falsifed. Ten brands deliberately kept below the of ampicillin were found to be required levels. This was also true of the two brands of co-trimoxazole suspension found to be substandard. Ten other Decomposition is not likely samples outside the British to be a major factor (no large Pharmacopoeia’s range had at amounts of decomposition least 90% or up to 126%. The bioavailability tetracycline content the pharmacopoeia prescribed of substandard product as standards. The power content determined from 48 h urinary of four brands was well below tetracycline excretion was the labeled amount of the signifcantly lower when standard drug.