Pharmaceutical objectives

Pharmacodynamic objectives Pharmaceutical objectives Pharmacokinetic objectives... 

Pharmaceutical objectives Improved formulation (e.g., increased hydrosolubility) Improved chemical stability Improved patient acceptance and compliance... 

Interestingly, increasing solubility is a pharmacokinetic as well as a pharmaceutical objective. Indeed, and as made explicit in the Biopharmaceutics Classification Scheme (BCS) [24], solubility is one of the main factors influencing oral absorption and hence oral bioavailability. 

Bernard Testa Introduction 559 Why Prodrugs 560 Pharmaceutical Objectives 560... 

The simultaneity of chemists collective acceptance of the StahUan theory of an order of chemical composition and their new interest in and classification of the compound proximate principles of plants is a coincidence that had important consequences. Stahl s theory reinforced a continuous development of chemists analytical practice, which in the decades before had been spurred mainly by chemists attempt to reconcile their analytical and pharmaceutical objectives. By the middle of the century, the theory of a graduated order of chemical composition lent a clear and distinctive voice to these earlier attempts. It was an important and new condition for the acceleration of an ontological shift, which may be easily overlooked when historical studies concentrate exclusively on events taking place in the laboratory. But there was a further condition, external to developments in the chemical laboratory, which contributed to this accelerated ontological shift. This third condition will be examined in detail in the next section. 

When designing an analytical procedure one has to consider the major pharmaceutical objectives in (Quality Control, being methods for identity, purity and assay. Those objectives may require different approaches depending on dosage form or depending on how, where and when the method is applied. Examples which require different considerations include, assays used for a product release decision, in-process controls (IPC) stability testing or measuring contamination of surfaces with antineoplastics. 

A challenging task in material science as well as in pharmaceutical research is to custom tailor a compound s properties. George S. Hammond stated that the most fundamental and lasting objective of synthesis is not production of new compounds, but production of properties (Norris Award Lecture, 1968). The molecular structure of an organic or inorganic compound determines its properties. Nevertheless, methods for the direct prediction of a compound s properties based on its molecular structure are usually not available (Figure 8-1). Therefore, the establishment of Quantitative Structure-Property Relationships (QSPRs) and Quantitative Structure-Activity Relationships (QSARs) uses an indirect approach in order to tackle this problem. In the first step, numerical descriptors encoding information about the molecular structure are calculated for a set of compounds. Secondly, statistical and artificial neural network models are used to predict the property or activity of interest based on these descriptors or a suitable subset. 

Much of the experimental work in chemistry deals with predicting or inferring properties of objects from measurements that are only indirectly related to the properties. For example, spectroscopic methods do not provide a measure of molecular stmcture directly, but, rather, indirecdy as a result of the effect of the relative location of atoms on the electronic environment in the molecule. That is, stmctural information is inferred from frequency shifts, band intensities, and fine stmcture. Many other types of properties are also studied by this indirect observation, eg, reactivity, elasticity, and permeabiHty, for which a priori theoretical models are unknown, imperfect, or too compHcated for practical use. Also, it is often desirable to predict a property even though that property is actually measurable. Examples are predicting the performance of a mechanical part by means of nondestmctive testing (qv) methods and predicting the biological activity of a pharmaceutical before it is synthesized. 

Areas of Continued Research. Research continues in many academic and pharmaceutical laboratories throughout the wodd with the objective of improving oral contraceptives and better understanding their pharmacological and clinical actions. 

All main aspects of analytical and bioanalytical sciences is covered by the conference program. AC CA-05 consists of 12 invited lectures and seven symposia General Aspects of Analytical Chemistry, Analytical Methods, Objects of the Analysis,. Sensors and Tests, Separation and Pre-concentration, Pharmaceutical and Biomedical Analysis, History and Methodology of Analytical Chemistry. Conference program includes two special symposia Memorial one, dedicated to Anatoly Babko and Analytical Russian-Germany-Ukrainian symposium (ARGUS-9). 

Authors are designed row sensitive and selective test-systems for analysis of heavy metals, active chlorine, phenols, nitrates, nitrites, phosphate etc. for analysis of objects of an environment and for control of ions Ee contents in the technological solutions of KH PO, as well as for testing some of pharmacological psychotropic daigs alkaloids (including opiates), cannabis as well as pharmaceutical preparations of phenothiazines, barbiturates and 1,4-benzodiazepines series too. 

Control of metalloid content in natural objects, foodstuff and pharmaceuticals is an important task for modern analytical chemistry. Determination of elements such as Arsenic is necessary for evaluation of object toxicity, since their content in environment may exceed MCL (maximum contaminant level), posing hazard to human health. Elements such as Selenium in definite doses are healthy, but in greater quantities they produce toxic effect. 

The Center for Chemical Process Safety (CCPS) identified the need for a publication dealing with process safety issues unique to batch reaction systems. Guidelines for Process Safety in Batch Reaction Systems, is the result of a project begun in 1997 in which a group of volunteer professionals representing major chemical, pharmaceutical and hydrocarbon processing companies, worked with Arthur D. Little Inc., to produce a book that attempts to describe the safe design and operation of batch reaction systems. The objectives of the book are to... 

The synthetic process proceeding under physiological conditions can be imitated in vitro with the object of establishing the validity of biogenetic hypotheses (293) as well as finding new potential routes for the synthesis of pharmaceuticals (294). 

Second Generation Second generation SERMs were developed with the objective of obtaining ER-targeted pharmaceuticals that lacked the utero-trophic and carcinogenic effects of tamoxifen. The most well characterized second generation SERM is... 

Pharmaceutical sites will usually create a dedicated team of validation specialists to coordinate all validation activities. They should operate according to a validation master plan that has been developed using risk analysis to identify the most critical systems requiring validation/re-validation. Before validating a system or process, a written protocol should be prepared that describes the system, the critical aspects, the objectives, the test methods and the acceptance criteria that will be applied. A validation report should be prepared on completion of each protocol. 

The sole objective of all hygiene and manufacturing controls is to ensure the quality of the pharmaceuhcal product for the safety and protection of the pahent. The manufacture of non-sterile pharmaceutical products requires that certain criteria of cleanliness, personal hygiene, produchon methods and storage must be met. Many such products are for oral and topical use and the question may fairly be posed as to the point of what are now quite stringent conditions. Nevertheless, some carefully controlled hospital studies have indeed shown that both types of medicine may be associated with nosocomial (hospital-acquired) infections and this risk can be minimized by the application of GMP principles. 

The first three objectives relate to pharmaceutical products, and the fourth to pharmaceutical usage although, in most countries, promoting rational use of dmgs is not part of regulatory activities. In order to achieve the four objectives, the various pharmaceutical activities— manufacturing, importation, exportation, distribution... 

Pharmaceutical Removal of suspended matter is a frequent application for MF. Processes may be either clarification, in which the main product is a clarified liquid, or solids recovery. Separating cells or their fragments from broth is the most common application. Clarification of the broth in preparation for product recovery is the usual objective, but the primary goal may be recovery of cells. Cross-flow microfiltration competes w l with centrifugation, conventional filtration by rotary vacuum filter or filter press and decantation. MF delivers a cleaner permeate, an uncontaminated, concentrated cell product... 

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