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Site Change for the Drug Substance A stand-alone packaging operation site change for solid For a change limited to an alternate manufacturing site for oral dosage–form drug products using containers and clo- the drug substance using similar equipment and manufac- sures in the approved application should be submitted as turing process purchase amlodipine overnight arrhythmia reentry, stability data on the drug substance may a Changes Being Effected Supplement buy 2.5 mg amlodipine overnight delivery heart attack risk assessment. No up-front sta- not always be necessary because amlodipine 10 mg with amex blood pressure medication reviews, for essentially pure drug bility data are necessary. The facility should have a current substances, stability is an intrinsic property of the material. The standard annual batches thereafter on long-term stability studies stability commitment should be made to conduct long-term using the approved protocol in the application and to sub- stability studies in accordance with the approved stability mit the resulting data in annual reports. Stability Testing of Drug Substances and Drug Products 63 A packaging site change for other than solid oral dos- G. The stability data packages for changes in container and closure of a drug product vary. Change in Testing Laboratory determining the stability data package recommendation is whether the protective properties of the container and clo- An analytical testing laboratory site change may be sub- sure system are affected by the proposed change. Protective mitted as a Changes Being Effected Supplement under properties of the container and closure system include, but certain circumstances. Changes that may affect these properties should be supported by a greater amount D. A solid dosage form will A change limited to the manufacturing process of the drug generally be less affected by a container change than a product, such as a change in the type of equipment used, liquid dosage form. Because considerably more informa- can be supported by the submission of sufficient data to tion will be needed to document a container and closure show that such a change does not alter the characteristics change than just stability data, applicants are encouraged or compromise the stability of the drug product. Such a modification to the approved stability protocol nature of the reprocessing procedure and any specific should be submitted as a Prior Approval Supplement. The effect it might have on the existing stability profile of the justification may include a demonstrated history of satis- drug. The expiration dating period for a reprocessed batch factory product stability, which may in turn include, but should not exceed that of the parent batch, and the expi- not be limited to, full long-term stability data from at least ration date should be calculated from the original date of three production batches. For example, drug products with an expiration procedure, which can range from repackaging a batch when dating period of less than 18 months should be tested at packing equipment malfunctions to regrinding and recom- quarterly intervals, products with an expiration dating pressing tablets. The appropriate chemistry review team period of 18 but not more than 30 months should be tested should be contacted to determine whether the reprocessing semiannually, and products with an expiration dating procedure is acceptable. Any batch of the drug product that period of 36 months or longer should be tested annually. Quinine actinometry as a method for calibrat- ing ultraviolet radiation intensity in light-stability testing of pharmaceuticals, Drug Dev. The design assumes that the stability of the inter- technological and biological products, some degradation mediate condition samples is represented by those at the products may be active. Examples of complex dosage forms Active ingredient that is intended to furnish pharmacolog- include modified-release dosage forms, metered-dose ical activity or other direct effect in the diagnosis, cure, inhalers, transdermal patches, and liposome preparations. Impurity — Any entity of the drug substance (bulk mate- Date of Production — Date that the first step of manu- rial) or drug product (final container product) that is not facture is performed that involves the combining of an the chemical entity defined as the drug substance, an active ingredient, antioxidant, or preservative with other excipient, or other additives to the drug product. For a biological product subject to but for which manufacture is critical to the successful pro- licensure, see the definition of date of manufacture in duction of the drug substance or the drug product. Modified release solid oral dosage forms life and retest period, which are claimed in the submission include both delayed and extended release drug products. The focus may instead be on ensuring the conditions that support the proposed retest date. Data on specificity of the assay, the completeness of the investiga- the drug product stored in the proposed container and tion of routes of degradation, and the use, if necessary, of closure for marketing under storage conditions that sup- identified degradants as indicators of the extent of degra- port the proposed shelf life. At a Random Sample — Selection of units chosen from a larger subsequent sampling point, different sets of samples of population of such units so that the probability of inclusion the total number would be tested. In a simple random the stability of the samples tested represents the stability sample, each unit has an equal chance of being included. The differences in the samples for the same Random samples are usually chosen with the aid of tables drug product should be identified as, for example, cover- of random numbers found in many statistical texts. Matrixing applicant relies in seeking approval of its abbreviated can cover reduced testing when more than one variable is application. This potential complexity precludes inclusion of spe- material is still suitable for use.

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Contraindicatons Optc neurits; children under 5 years-unable to report symptomatc visual disturbances; severe renal impairment; hypersensitvity 10mg amlodipine free shipping blood pressure medication overdose treatment. Precautons Visual disturbances-ocular examinaton recommended before and during treatment (see note below); reduce dose in renal impairment (Appendix 7d) and monitor plasma concentraton; elderly; pregnancy (Appendix 7c) (not known to be harmful); lactaton discount 2.5mg amlodipine free shipping arrhythmia nos. Note: Patents should report visual disturbances immediately and discontnue treatment; children who are incapable of reportng symptomatc visual changes accurately should be given alternatve therapy buy amlodipine 2.5 mg fast delivery blood pressure 39 year old male, as should, if possible, any patent who cannot understand warnings about visual adverse efects Adverse Efects Optc neurits-reduced visual acuity and red/ green colour blindness (early changes usually reversible, prompt withdrawal may prevent blindness); peripheral neurits-especially in legs; gout; rarely, rash, pruritus, urtcaria, thrombocytopenia; pulmonary infltrates gastrointestnal upset. Isoniazid* Pregnancy Category-C Schedule H Indicatons Tuberculosis, in combinaton with other drugs; tuberculosis prophylaxis also. Patents or their caretakers should be told how to recognize signs of liver disorder and advised to discontnue treatment and seek immediate medical atenton if symptoms such as nausea, vomitng, malaise or jaundice develop. Adverse Efects Gastrointestnal disorders including nausea and vomitng, diarrhoea and pain, also constpaton, dry mouth; hypersensitvity reactons including fever, rashes, joint pain, erythema multforme, purpura usually during frst weeks of treatment; peripheral neuropathy; blood disorders including agranulocytosis, haemolytc anaemia, aplastc anaemia; optc neurits, toxic psychoses and convulsions; hepatts (especially over age of 35 years and regular users of alcohol)-withdraw treatment; also reported systemic lupus erythematosus- like syndrome, pellagra, hyperrefexia, difculty with micturiton, hyperglycaemia and gynaecomasta; memory impairement, elevated serum transaminase, rheumatc syndrome, pyridoxine syndrome. Kanamycin Pregnancy Category-D Schedule H Indicatons Tuberculosis; hepatc coma; penicillin resistant gonorrhoea, chronic bacterial infectons. Contraindicatons Lactaton; pregnancy (Appendix 7c); hypersensitvity; renal impairment. Precautons Myasthenia gravis; renal impairment; elderly patents with neuromuscular disorder. Adverse Efects Nephrotoxicity; ototoxicity; skin rash; urtcaria; neuromuscular blockade; malabsorpton syndrome. Pyrazinamide* Pregnancy Category-C Schedule H Indicatons Tuberculosis, in combinaton with other drugs. Precautons Hepatc impairment (monitor hepatc functon; (Appendix 7a); renal impairment (Appendix 7d); diabetes mellitus (monitor blood glucose-may change suddenly); gout; pregnancy (Appendix 7c) and lactaton; hypouricemia. Patents or their caretakers should be told how to recognize signs of liver disorder and advised to discontnue treatment and seek immediate medical atenton if symptoms such as persistent nausea, vomitng, malaise or jaundice develop. Adverse Efects Hepatotoxicity including fever, anorexia, hepatomegaly, splenomegaly, jaundice, liver failure; nausea, vomitng; arthralgia; gout; sideroblastc anaemia; rash, photosensitvity; porphyria, dysuria, thrombocytopenia, hyperplasia, myalgia. Child- 10 to 20 mg/kg body weight daily, same dose for meningococcal carriers but for 4 days. Precautons Reduce dose in hepatc impairment (Appendix 7a); liver functon tests and blood counts required in liver disorders, alcohol dependency, elderly and on prolonged therapy; renal impairment (if dose above 600 mg daily); lactaton; porphyria; discolours sof contact lenses; advise patents on oral contraceptves to use additonal means; interactons (Appendix 6b, 6c, 6d); pregnancy (Appendix 7c); cerebral haemorrhage, visual disturbances. Note: Resumpton of rifampicin treatment afer a long interval may cause serious immunological reactons, resultng in renal impairment, haemolysis, or thrombocytopenia-discontnue permanently if serious adverse efects occur Patents or their caretakers should be told how to recognize signs of liver disorders and advised to discontnue treatment and seek immediate medical atenton if symptoms such as persistent nausea, vomitng, malaise or jaundice develop. Adverse Efects Severe gastrointestnal disturbances includ- ing anorexia, nausea, vomitng and diarrhoea (antbiotc-associated colits reported); head- ache, drowsiness; rashes, fever, infuenza-like syndrome and respiratory symptoms, col- lapse, shock, haemolytc anaemia, acute renal failure and thrombocytopenic purpura-more frequent with intermitent therapy; altera- tons of liver functon-jaundice and potental- ly fatal hepatts (dose related; do not exceed max. Precautons Combined preparaton usually not suitable for use in children; see under Rifampicin and Isoniazid; pregnancy (Appendix 7c). Rifampicin + Isoniazid + Ethambutol Pregnancy Category-C Schedule H Indicatons Tuberculosis. Rifampicin + Isoniazid + Pyrazinamide Pregnancy Category-C Schedule H Indicatons Tuberculosis, in combinaton with other drugs. Contraindicatons Combined preparaton not suitable for use in children; see Rifampicin, Isoniazid and Pyrazinamide; pregnancy (Appendix 7c). Rifampicin + Isoniazid + Pyrazinamide + Ethambutol Pregnancy Category-C Schedule H Indicatons Tuberculosis. Streptomycin* Pregnancy Category-D Schedule H Indicatons Tuberculosis, in combinaton with other drugs. Precautons Children-painful injecton, avoid use if possible; renal impairment (Appendix 7d), infants and elderly (dosage adjustment and monitor renal, auditory and vestbular functon and plasma streptomycin concentratons); interactons (Appendix 6c). Adverse Efects Vestbular and auditory damage, nephrotoxicity; hypersensitvity reactons- withdraw treatment; paraesthesia of mouth; rarely, hypomagnesaemia on prolonged therapy; antbiotc-associated colits; also, nausea, vomitng, rash; rarely, haemolytc anaemia, aplastc anaemia, agranulocytosis, thrombocytopenia; pain and abscess at injecton site. Thiacetazone + Isoniazid Pregnancy Category-C Schedule H Indicatons Tuberculosis, in combinaton with other drugs. Precautons See Isoniazid; determine efcacy and toxic- ity of thiacetazone-geographical diferences; hypersensitvity reactons-withdraw treat- ment; Pregnancy (Appendix 7c).

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Therefore purpose have to be most transparent and available to each of your clients cheap amlodipine 2.5 mg with amex blood pressure of normal person. And to achieve it order amlodipine with paypal arrhythmia test questions, each employee has to be the voluntary carrier and the sincere herald of your ideas purchase amlodipine 10mg mastercard arrhythmia update 2010. Customer loyalty marketing focuses on incentivizing your current customer base to make more purchases. Its refers to any kind of interaction that builds trust or a desire to maintain relationship with us. To build customer loyalty, customer experience management blends the physical, emotional and value elements of an experience into one cohesive experience. Based on the aim, formulated the following tasks: to study the theoretical foundations of marketing mix in pharmacy as a basis for the formation of customer loyalty; to analyze foreign and domestic experience in building loyalty programs; to identify factors and the most effective methods to increase customer loyalty; to analyze the situation with the client flow in pharmacies and identify problems and lacks of work with clients; to develop of proposals for the formation of loyalty programs for pharmacy. There are several methods for determining the level of loyalty heuristic (expert); differentiated; graphically mathematics and method of assessing the level of quality and price of loyalty. During preliminary researches, offered a number of actions for increase of loyalty of clients. Capture customer contact information: when a new customer comes into the pharmacy, want to obtain his/her permission to collect their name, phone number and email. Personally reach out: calling the patients to ask if they have questions concerning their new medications, according to some medication, they need to be followed. Go above and beyond: show the customer that you care, send written personal letters, thanking them for being a loyal customer, without any marketing messages. Create a points or loyalty program: so 393 important program, to create repeat customer, customer will continue to return in order to earn more points that could help save through merchandise discounts. A loyal customer is one who is willing to invest in the relationship by sticking with your business even if your price is not always the best, at the same time your pharmacy offer the best service. Loyal customers will become the most effective ―sales team‖ you could ever built, spreading the good news about your pharmacy to everyone in their network. The call to the client, the letter, a congratulation on a holiday takes only 2-3 minutes of time of your employee, however sometimes they it is much more productive than thousands of dollars spent for advertising. Therefore, basis of any loyalty program of clients this maintenance of continuous human contact, bilateral exchange of positive emotions. However it happens so that the client after all leaves for various reasons: the financial policy of the company has changed, the management, etc. But it is impossible to lose really loyal client with whom you managed to construct the deep, positive relations for 100% as even if he also leaves, he leaves happy. If you have managed to solve it from the first, qualitatively, completely, that the probability is high that the client remained happy. Such client can come again; can make the recommendation, referring not to low price, and to the fact that in your pharmacy he was really helped. Thus, the formation of customer loyalty is a real investment in the long-term and productive relationship with consumers. Learning and development, increasing its professionalism, taking into account trends in the development of self-population, orientation to the intangible pharmacy assets, continuous improvement of product range and price policy, create and work with the customer database allows the pharmacy to achieve financial and economic activity desired results not only in the short term, but also in the long term. The purpose of further researches it to develop system of loyalty for pharmacy of Lebanon. Pharmaceutical business of Lebanon has the features, which need to be considered during creation of programs of loyalty. The steadily increasing fungal resistance to existing antifungal medicines is a serious problem, and therefore there is a great need to search for new classes of antifungal substances, especially from natural sources. Unlike synthetic drugs, antifungal substances of plant origin are not associated with side effects and have a great therapeutic potential to heal many fungal diseases. Acorus calamus, which is commonly known as Sweet flag is a medicinal plant used for the treatment of various disease and disorders. The rhizome part of Acorus Calamus is found to possess the antifungal activity against the yeast strain of Candida Albicans and other fungi strains. The genus Eucalyptus is known for its rich source of bioactive compounds which show high inhibitory activities against C. The aim of our work was to develop composition, the scientifically and experimentally grounded technology of the syrup on the base of Acorus Calamus rhizome extract and Eucalyptus extract with antifungal activity and studying of stability of this syrup. The object of our researches was an Acorus Calamus rhizome extract, Eucalyptus extract and syrup on its basis.

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It is thought that drug microspheres take up water from the cells buy amlodipine on line amex blood pressure medication weight loss, causing the cells to dehydrate and “shrink” purchase amlodipine 10mg on line arteria3d urban decay city pack, thereby inducing the transient widening of the intercellular junctions and increased drug transport 2.5mg amlodipine overnight delivery sinus arrhythmia 1102. Work in this field has concentrated on the use of poly(lactide-co-glycolide) microparticles, which have the advantages of being biocompatible, biodegradable and well tolerated in humans. Promising results have also been obtained with the use of biodegradable starch microspheres in conjunction with the absorption enhancer lysophosphatidylcholine. However, in general, only low levels of antibodies have been induced by intravaginal immunizations and the antibodies generated have been predominantly localized in the genital tract, even in the presence of potent antigen delivery systems. Such formulations are prone to leakage, which can result in: • low efficacy, due to limited contact time with the absorbing surface; • poor compliance. Bioadhesive polymers can be used to prolong the contact of a drug with a mucosal surface, without inducing adverse local effects on the epithelium. Other beneficial effects conferred by the use of bioadhesive polymers include: • increasing the local drug concentration at the site of adhesion/absorption; • protecting the drug from dilution and possible degradation by vaginal secretions; • prolonging the contact time of the dosage form near the absorbing surface. Thus such polymers have attracted considerable interest as a means of improving drug delivery at mucosal sites, including the vagina. Reference has already been made to the promising results obtained using bioadhesive hyaluronane ester microspheres for vaginal drug delivery. Other bioadhesive polymers under investigation include: Polycarbophil Polycarbophil, a poly(acrylic acid) lightly cross-linked with divinyl glycol, can remain on vaginal tissue for extended periods and has demonstrated many potential clinical applications: 296 Dry vagina: the bioadhesive gel can hydrate vaginal tissue for 3–4 days after a single application. Tissue hydration is caused by an increased blood flow, thus increasing transudation of vaginal fluid though the intercellular channels of the vaginal epithelium. Clinical assessment of local tissue pH in postmenopausal women shows a reduction in pH from about 7 to 4 and maintenance of this acidic pH for about 3–4 days. This acidic pH is an unfavorable environment for pathogens, thereby protecting against bacterial vaginosis. Spermicide-antiviral: the polymer appears to be an effective delivery system for the spermicidal/antiviral agent nonoxynol-9. By its ability to adhere to vaginal tissue while retaining nonoxynol-9 in its gel structure, it is an excellent extended effect spermicide. In contrast, the bioadhesive gel containing nonoxynol-9 attaches to lymphocytes and maintains sufficient contact time to allow the nonoxynol-9 surfactant to disrupt the cell wall, thus eliminating the lymphocyte and killing the virus within. Progesterone delivery: as described above, estrogen replacement therapy increases the risk of endometrial cancer when used alone. This risk can be eliminated by treatment with a progestational agent for up to 14 days a month. The vaginal delivery of a polycarbophil gel loaded with progesterone has been shown to allow the extended vaginal delivery of the drug for 2–3 days from a single dose and protect the endometrium against cancer. Low serum levels of progesterone were detected after vaginal delivery, which corresponds to fewer side-effects. A commercial progesterone-loaded polycarbophil gel preparation for intravaginal delivery, Crinone, has recently been launched. Smart hydrogel Smart hydrogel preparations, comprising poly(acrylic acid) and a poloxamer (see Section 16. The temperature- dependent gelling of the system helps to prevent leak-back and provides sustained release properties. Smart hydrogel preparations containing estradiol have shown similar bioavailability to a commercial vaginal cream and suppository, even though the gel contained only 20% of the relative estradiol dose. However, the low and erratic bioavailability of biopharmaceuticals via this route necessitates the use of absorption enhancers. Until safe, non-toxic absorption enhancers can be found, the route is of limited potential. A further major limitation of this route is the lack of reproducibility resulting from cyclic changes in the reproductive system. Finally, no matter what degree of optimization can be achieved via this route, it can only ever benefit approximately 50% of the population! Mucosal penetration enhancers for facilitation of peptide and protein drug absorption. Give examples of the classes of the pharmaceutical agents which are presently marketed as topical formulations for vaginal administration. Which other epithelial membrane has a structure most similar to that of the vaginal epithelium?

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