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VA Medicaid PDL List (effective 07/01/2011)
VA Medicaid PDL List (effective 07/01/2011)

... Not all medications listed are covered by all DMAS programs. Check individual program coverage. For program drug coverage information, visit the following: http://www.VirginiaMedicaidPharmacyServices.com All new products included in a PDL class are automatically non-preferred until reviewed by the P ...
Biowaiver extension potential to BCS Class III high solubility
Biowaiver extension potential to BCS Class III high solubility

... Thus, it is evident that if the formulation of metformin IR product is rapid dissolving, dissolution will not affect availability of metformin. Using the rationale of the BCS, it can be argued that biowaivers can be granted for metformin IR products on the basis of in vitro dissolution profiles. The ...
Over-the-Counter Medications
Over-the-Counter Medications

Nanoparticles as `smart` pharmaceutical delivery
Nanoparticles as `smart` pharmaceutical delivery

... nanoparticle is used in various drug deliveries. This drug delivery is used for controlled release of pharmaceutical ingredients (31). To evaluate its bioadhesive properties, gliadin nanoparticle was added to carbazole in two forms i.e. non-hardened gliadin nanoparticles (NPs) as well as cross-linke ...
Charles University in Prague Faculty of Pharmacy in Hradec Králové
Charles University in Prague Faculty of Pharmacy in Hradec Králové

... pharmacological activities, such as antibacterial, antifungal and anti-inflammatory, among others. Furthermore; several studies reported their potent antimycobacterial effect. Their activity results from multiple mechanisms. They are therefore interesting compounds for medicinal chemists. As phenoli ...
Solubility enhancement technique for an anti-malarial
Solubility enhancement technique for an anti-malarial

... Atovaquone is an Anti-malarial agent and is used in the treatment of malarial complications as chemoprophylaxis. The present research work is focused with an aim to increase solubility and hence dissolution rate of Atovaquone by using the various techniques of preparation of solid dispersion. The po ...
this PDF file
this PDF file

CLSI 2014 AST Update - Log into your Online Media Solutions portal
CLSI 2014 AST Update - Log into your Online Media Solutions portal

... Janet A. Hindler, MCLS, MT(ASCP), Senior Specialist, Clinical Microbiology UCLA Medical Center Los Angeles, California, USA Ms. Hindler has worked as a clinical microbiologist for over 40 years, the past 35 at UCLA Medical Center, Los Angeles, CA. She has written and taught extensively in the area o ...
Pfizer Inc 235 East 42"° Street 235/24/l0A New York, NY 10017-5755
Pfizer Inc 235 East 42"° Street 235/24/l0A New York, NY 10017-5755

... ANDA or 505(b)(2) application should be deemed to contain a paragraph II certification-and thus be subject to pediatric exclusivity-as a matter of law. See Mylan Labs. v. Thompson, 389 F .3d 1272, 1282-83 (DC Cir. 2004) (upholding FDA's conclusion that upon patent expiry, patent certification change ...
The PBAC agenda primarily consists of applications relating to the
The PBAC agenda primarily consists of applications relating to the

... circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be listed in alphabetical order by drug name. There is no provision for consumer comments to the PBAC on agenda item 8 which relates to pricing matters. Pharmaceu ...
an-update-of-taste-m.. - Scholars Research Library
an-update-of-taste-m.. - Scholars Research Library

... pH 6.8 but readily, dissolves at gastric pH 1.2 could be a good candidate for taste masking. Choosing one of these polymers is not a simple selection. Before making a decision on coating material following factors must be considered. The particle size of drug, flow characteristics of drug, moisture ...
drug registration guidance document
drug registration guidance document

... provisions of these Regulations and which in particular relate to - (a) product quality, safety and efficacy; (b) labeling; (c) change of particulars of a product; (d) transfer of licences; (e) manufacturing; (f) storage includes requirements as to containers; (g) retailing; (h) promotion of sale in ...
Final Version , 454kb - Erasmus University Thesis Repository
Final Version , 454kb - Erasmus University Thesis Repository

... (Kvesic, 2008). These examples are shown in Table 1. An XR is a renewed drug where the active ingredient is released slower in the body; it contains the same active molecule. An indication expansion is a strategy in which a drug is used for a new indication. A second generation is a strategy in whic ...
Pfizer Inc 235 East 42'' Street 235/24/l0A New York.  NY 10017-5755
Pfizer Inc 235 East 42'' Street 235/24/l0A New York. NY 10017-5755

... ANDA or 505(b)(2) application should be deemed to contain a paragraph II certification-and thus be subject to pediatric exclusivity-as a matter of law. See Mvlan Labs . v. Thompson, 389 F.3d 1272 . 1282-83 (DC Cir. 2004) (upholding FDA's conclusion that upon patent expiry, patent certification chang ...
Letter to Commissioner Hamburg, March 28, 2011
Letter to Commissioner Hamburg, March 28, 2011

... cigarettes were balmed in the United States. According to the documents, the purpose of these actions was to introduce a strikingly similar product and avoid FDA regulation. Kretek' s plans apparently started as earl y as 2007. In an e-mail dated October 15, 2007, a senior executive wrote that one o ...
pharmacy technical assistance - Ministère de l`Éducation et de l
pharmacy technical assistance - Ministère de l`Éducation et de l

... A situational competency describes the situation in which students are placed to acquire learning, and allows for actions and results to vary from one student to another. It consists of the following features: The statement of the competency is the result of the job analysis, the orientations and ge ...
Compatibility and stability studies of levadopa, carbidopa
Compatibility and stability studies of levadopa, carbidopa

... having different pH values acidic and basic3-6. The main goal of these stability studies is to obtain information about different factors such as temperature, pH, humidity, light that affect the stability of the drug substance, potential degradation pathways of the substance, main degradation produc ...
1 CURRICULUM VITAE PHILIP J. SCHNEIDER
1 CURRICULUM VITAE PHILIP J. SCHNEIDER

... Teaching and health services research with the Masters in Public Health (MPH) students enrolled at the Phoenix campus. Senior Policy Advisor, Health Transformation Institute, Scottsdale, AZ The Healthcare Transformation Institute (HTI) is a nonprofit organization dedicated to creating health value b ...
Procedure
Procedure

... Slowly inject medication, observing for wheal ( blister) formation and blanching at site. Rationale: wheal formation indicates proper injection. If no wheal develop, injection was given too deeply. ...
Evaluating Development and Production Costs: Tablets Capsules
Evaluating Development and Production Costs: Tablets Capsules

... primary and secondary manufacturing. Primary produces the active ingredient, such as paracetamol and methyldopa, and secondary the dosage form, such as the tablet, capsule or injection. Companies are now rationalizing manufacturing to concentrate products at specific sites that give economies of sca ...
proposed rule
proposed rule

... intended for use by the health care professional. Prescribing information is subject to the format and content requirements of §§ 201.56, 201.57, 201.80, 606.122, or 610.61 (21 CFR 201.56, 201.57, 201.80, 606.122, or 610.61). Prescribing information is currently distributed in paper form with the pr ...
Consolidated List of Products Whose Consumption and/or Sale
Consolidated List of Products Whose Consumption and/or Sale

... countries, who may not have easy access to the Internet or for those who would like to continue to receive the publication in the printed version for reasons of their own. In this regard, it should be understood that to obtain complete coverage, the present issue could only be used in conjunction wi ...
10.4103_0975-1483.63169
10.4103_0975-1483.63169

Taste Masking: A Novel Approach for Bitter and Obnoxious Drugs
Taste Masking: A Novel Approach for Bitter and Obnoxious Drugs

... Taste is one of the most important parameters governing patient compliance. Undesirable taste is one of several important formulation problems that are encountered with certain drugs. Oral administration of bitter drugs with an acceptable degree of palatability is a key issue for health care provide ...
NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen
NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen

... acetaminophen warning label that prints within the top 3 warning labels for all prescription acetaminophen-containing medicines dispensed in their pharmacy. b. Guidance for Continued Implementation For pharmacies who have not yet implemented the standard warning label on their acetaminophen-containi ...
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Compounding

Pharmaceutical compounding (done in compounding pharmacies) is the creation of a particular pharmaceutical product to fit the unique need of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose(s) needed or deemed best of particular active pharmaceutical ingredient(s). It may also be done for more optional reasons, such as adding flavors to a medication or otherwise altering taste or texture. Compounding is most routine in the case of intravenous/parenteral medication, typically by hospital pharmacists, but is also offered by privately owned compounding pharmacies and certain retail pharmacies for various forms of medication. Whether routine or rare, intravenous or oral, etc., when a given drug product is made or modified to have characteristics that are specifically prescribed for an individual patient, it is known as ""traditional"" compounding.Due to the rising cost of compounding and the shortage of drugs, many hospitals have shown a tendency to rely more upon large-scale compounding pharmacies to meet their regular requirement, particularly of sterile-injectable medications. When compounding is done on bulk production of a given formulation rather than patient-specific production, it is known as ""non-traditional"" compounding (which, as discussed below, is arguably not ""compounding"" but rather ""manufacturing""). This development raises concerns about patient safety and makes a case for proper regulatory control and monitoring.
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