Pharmaceutical assessments

This part of the chapter is based on consideration of the published EPARs at the EMEA s web site. At the time of writing there were more than 60 EPARs available. The contents of the pharmaceutical assessment section of each of these were examined, and detailed notes were made from more than 50 of those documents. The amount of information in the different EPARs varies considerably. Some have specific sections with the heading development pharmaceutics, while others include relevant information in the text without a heading. In some cases there are simple statements to the effect that satisfactory pharmaceutical development data were submitted. Therefore, an attempt has been made to glean information of a general nature, and this will be presented as a discussion of relevant topics by dosage form. 

Devices used for delivery of the drug (such as inhalers) are another area requiring an integrated clinical and pharmaceutical assessment for their performance, ease of use, and implications for safety and efficacy. 

Human Pharmaceuticals Assessing the Impacts on Aquatic Ecosystems... 

For products that are prepared extemporaneously at a regular basis or even for a limited stock, a product specific documentation (product file) is needed. This will include specifications, instructions, and records but also a pharmaceutical assessment of safety data, toxicity, biopharmaceutical aspects, stability, and product design. The product file should also include a product review as soon as a product is used repeatedly or over longer periods. 

The six programmes that constitute the TTP are the Pharmaceutical Assessment responsible for premarket evaluation of drugs the Medical Devices Programme responsible for the administration and enforcement of the new medical devices regulations the Biologies and Radiopharmaceuticals Bureau Drug Surveillance Compliance and Enforcement and the Policy and Coordination Division. 

Canada has a cost recovery programme in place for pharmaceutical products. The fees are negotiated between Pharmaceutical Assessment and the manufacturer, Costs vary but are substantial. 

Bureau of Compliance and Enforcement Bureau of Biologies and Radiopharmaceuticals Bureau of Pharmaceutical Assessment... 

C, J. H, Porter. W. N. Channan. Model systems for intestinal lymphatic transport studies. In R, T. Borchardt. P. L. Smith. G. Wilson, eds. Model Sy.stems for Bio-pharmaceutical Assessment of Drug Absorption and Metabolism. New York Plenum Press, 1996. pp, 85-102. 

GPP touches upon the processes assessment of the physician s prescription or formulation design in the Documentation paragraph a pharmaceutical assessment of therapeutic rationale, safety data, toxicity, biopharmaceutical aspects, stability and product design should be carried out, before preparation takes place. No further details are established however. 

In the United States, through the NDA review process, pharmaceutical companies that seek FDA approval for new dmg products are assessed user fees by FDA to gain faster approval, by virtue of the U.S. Prescription Dmg User Fee Act of 1992. These assessments are used to increase the new dmg review staff of the FDA, which has agreed to reduce the NDA review time to 12 months by 1997 (6). 

Chemical Toxicity. Radiopharmaceuticals are subject to the same requirements for safety as are other pharmaceuticals, and are tested for chemical toxicity in much the same manner. It is generally understood, however, that patients are likely to receive relatively few doses of any given radiopharmaceutical so that the effects of long-term chronic exposure to the compound rarely need be assessed. Safety margins, that is, the ratio of the adininistered dose to the lowest dose that produces an observable effect, are usually on the order of 100 or more. 

Getting to gups with manual handling pharmaceutical a abort guide for employers Health surveillance in the pharmaceutical industry (COSHHj Emergency action for burns Eive steps to risk assessment... 

A not-for-profit toxicology research institute that provides an improved scientific basis for understanding and assessing the potential adverse effects of chemicals, pharmaceuticals, and consumer preducts on human health. 

It was apparent that the FDA recognized the ability of the pharmaceutical industry to develop chiral assays. With the advent of chiral stationary phases (CSPs) in the early 1980s [8, 9], the tools required to resolve enantiomers were entrenched, thus enabling the researcher the ability to quantify, characterize, and identify stereoisomers. Given these tools, the researcher can assess the pharmacology or toxicology and pharmacokinetic properties of enantiopure drugs for potential interconversion, absorption, distribution, and excretion of the individual enantiomers. 

Santos JL, Aparicio I, Alonso E (2007) Occurrence and risk assessment of pharmaceutically active compounds in wastewater treatment plants. A case study Seville city (Spain). Environ Int 33 596-601... 

Ferrari B, Mons R, Vollat B, Fraysse B, Paxeus N, Lo Giudice R, Pollio A, Garric J (2004) Environmental risk assessment of six human pharmaceuticals are the current enviommental risk assessment procedures sufficient for the protection of the aquatic environment Environ Toxicol Chem 23 1344-1354... 

Sadezky A, Loffler D, Temes T (2008) Proposal of an environmental indicator and classification system of pharmaceutical product residues for environmental management KNAPPE project Knowledge and need assessment on pharmaceutical products in environmental waters . Contract n° 036864. Deliverable 1.2. http //www.knappe-eu.org/... 

Quantified evaluation of drugs that could have been identified in herbal texts. It would be a valuable assessment to quantify the number of pharmaceuticals that have been described with the correct purported uses in an herbal text. A project of this nature would incorporate selecting a historic... 

A recent review of option models in drug development, co-authored by a biostatistician from AstraZeneca in Molndal, Sweden [14], suggests that there has up to now been a lack of appreciation among pharmaceutical executives of the value that statistics could bring to the decision making process. This review quantifies the value of information that could terminate unsuccessful projects early and assesses the time-risk trade-off. It proves that projects split... 

Office of Technology Assessment. Pharmaceutical R D costs, risks, and rewards, OTA-H-522 (February 1993). 

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