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Drug products availability

Validation of analytical procedures methodology Guideline on Impurities in New Drug Substances Guideline on Impurities in New Drug Products Availability Notice... [Pg.76]

A typical example is ibuprofen. The BCS-relevant characteristics of the drug are given in Table 5. Obviously, there will be little or no dissolution of ibuprofen under typical gastric conditions in the fasted state. However, the D S falls almost within the BCS limit of < 250 mL at pH 6.8, so it can be assumed that dissolution into a standard volume of medium (e.g., 500 mL, as recommended in Table 3) can be completed. This assumption is borne out by the results for dissolution of the pure drug and several IR oral drug products available on the European market as shown in Figure 4. [Pg.208]

TABLE 2 Drug Products Available for Buccal and/or Sublingual Application Using Mucoadhesive Polymers ... [Pg.178]

Drug Indications Module Identification of all drug products available to treat a specific condition. [Pg.83]

Accelerated Approval—This is a program that the FDA developed to make new drug products available for life-threatening diseases when they appear to provide a benefit over available therapy (which could mean that there was no existing effective treatment). This guidance provides additional information http //www.fda.gov/cder/guidance/5645fnl.htm. [Pg.59]

Table 2 Drug products available for buccal and/or sublingual application using mucoadhesive polymers... Table 2 Drug products available for buccal and/or sublingual application using mucoadhesive polymers...
Bioavailahility is defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. [Pg.64]

Incyte. Incyte s Product Pipeline at Incyte Pharmaceuticals/Pflzer. Available at http //www.incyte.eom/drugs product pipeline.html chemokine. [Pg.191]

For this calculation, it is unnecessary to assume that Vd and/or kei are the same for the two studies. It is only necessary that fe be the same in both studies. This is usually a valid assumption unless the drug undergoes a significant amount of first-pass metabolism in the gut wall or liver following oral administration or a significant amount of decomposition at an intra muscular (IM) injection site. When this occurs, the availability of the extravascular dosage form may appear to be low, but the fault will not lie with the formulation. The bioavailability will be a true reflection of the therapeutic efficacy of the drug product, and reformulation may not increase bioavailability. [Pg.96]

W. H. Barr, Factors involved in the assessment of systemic or biologic availability of drug products, Drug Inf. Bull, 3, 27—45 (1969). [Pg.144]

To determine whether human testing for a new drug or new drug product is reasonable, it is first necessary to conduct preclinical studies and to submit the IND. The necessary information needed to prepare the IND is outlined in Table 1. The IND is to contain information on appropriate prior animal studies for safety evaluation, any available clinical data, adequate drug identification and manufacturing instructions, and a detailed outline of the proposed clinical study, routs of administration, approximate number of patients to be used, and an estimate of the length of treatment and an environmental impact statement. [Pg.630]

Best available descriptive name of the drug product and how it is to be administered... [Pg.634]

The topic of generic bioequivalence pertains to the relative bioavailability of different versions of the same drug product, all of which may be available in the marketplace at the same time. Thus, if we continue our consideration of the example introduced in the previous section of this chapter, let us suppose that the innovator did obtain approval to market F3. Initially F3 was the only product available in the marketplace. However, when the relevant patents held by the innovator have expired, other pharmaceutical... [Pg.747]


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See also in sourсe #XX -- [ Pg.739 ]




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