Pharmaceutical scientists, method

A number of alternative sizing methods are available, and these are described in Table 8. The American Association of Pharmaceutical Scientists, Inhalation Focus Group conducted a comprehensive review of available methods, which was published in a series of articles identified in the last column of the table. All of the methods described either have been or are currently employed in the development of aerosol products. However, at this time only the inertial samplers, cascade impactors and impingers appear in compendial standards and in regulatory guidelines [44-46], Other methods such as thermal imaging are also under development and may give complementary size information to the current methods. 

In recent years pharmaceutical scientists have participated in lively discussions about how present methods of bioequivalency determination might legitimately and advantageously be modified. For example, the question of whether it is necessary to always take plasma samples so that AUC at the end of the test is at least 90% of AUC at time infinity has been explored [7,8], Statistical aspects of this and other possible methods of modifying protocol design are covered in a most useful book published in 1999 and in several papers [8-10,22],... 

In many respects, differential scanning calorimetry (DSC) is similar to the DTA method, and analogous information about the same range of thermal events can be obtained. However, DSC is far easier to use routinely on a quantitative basis, and for this reason it has become the most widely used method of thermal analysis. The relevance of the DSC technique as a tool for pharmaceutical scientists has been amply documented in numerous reviews [3-6,25-26], and a general chapter on DSC is documented in the U.S. Pharmacopeia [27]. 

The XRPD technique has become exceedingly important to pharmaceutical scientists, since it represents the easiest and fastest method... 

During the 1990 Washington Conference on Analytical Methods Validation Bioavailability, Bioequivalence and Pharmacokinetic Studies [1], parameters that should be used for method validation were defined. The final report of this conference is considered the most comprehensive document on the validation of bioanalytical methods. Many multinational pharmaceutical companies and contract research organizations contributed to its final draft. This scientific meeting was sponsored by the American Association of Pharmaceutical Scientists (AAPS), the Association of Official Analytical Chemists (AOAC), and the U.S. Food and Drug Administration (FDA). The conference report has been used as a reference by bioanalytical laboratories and regulatory agencies worldwide. 

The most important physical properties of polymers are their molecular weight and its distribution. Many characteristics of polymers, including solubility, dissolution rate, rigidity, and tensile strength, are dependent on molecular weight. Pharmaceutical scientists should know the molecular weights of the polymers they use or determine them for quality control purposes. In this section, several methods used to determine the molecular weight of polymers will be described. 

Also, throughout this chapter we focus on analytical challenges a pharmaceutical scientist encounters during method development these include speed... 

Even though, there is no cookbook for HPLC method development this book provides several strategies that the reader could use when presented with a particular situation. These strategies could be stored as tools in the scientists method development arsenal, and drawn from when needed to tackle a particular separation. Moreover, some novel approaches for implementing HPLC, fast HPLC, and hyphenated HPLC techniques towards pharmaceutical analysis are discussed. This book has the potential to serve as a useful resource for the chromatographic community. It can be used as a handbook for the novice as well as the more experienced pharmaceutical chemist who utilizes HPLC as an analytical tool to solve challenging problems regularly in the pharmaceutical industry. 

Cocrystals are becoming increasingly important as a means of controlling the properties of pharmaceutical solids by designing multiple component molecular networks that introduce the desired functionality. Because cocrystal design is based on supramolecular synthesis, it provides a powerful approach for the proactive discovery of novel pharmaceutical solid phases. Application of the fundamental concepts presented here on cocrystallization processes is essential for the pharmaceutical scientist to anticipate the formation of cocrystals during pharmaceutical processes and storage, as well as to develop reliable methods for cocrystal discovery and production. 

AAPS Workshop. Bioanalytical Methods Vahdation for Macromolecules, Arlington, VA, March 1-3 2000 American Association of Pharmaceutical Scientists Alexandria, VA. 

Shaw, J.M. Sullivan, B.M. Bowen, W.E. Martin, G.P. Reed, R.A. Studies Directed Towards the Development of Enzymatic Dissolution Test Methods for Cross-Linked Hard Gelatin Capsule Formulations Containing Poorly Water-Soluble Drug Substances. Abstracts of the AAPS Annual Meeting, New Orleans, LA, Nov 14-18, 1999 American Association of Pharmaceutical Scientists Arlington, VA, 1999 Abstract No. 3358. 

Design standards intrinsically must be more detailed, more complex, more arbitrary, and more authoritarian than performance standards. Specific formulas can be specified by USP-NF, as can methods of compounding or processes of manufacture if necessary. However, end-product testing is believed by most pharmaceutical scientists to be adequate public... 

Death and taxes, as the old adage goes, are the only certainties in life. Although this is an overstatement, it does emphasize the uncertain world in which the pharmaceutical scientist lives and works. Faced with estimates of product characteristics such as potency, content uniformity, impurity levels, and dissolution performance, the scientist must make important go/ no-go decisions. These estimated values, as is true for most measured quantities, inherently vary from the true values on which correct decisions depend. Statistical methods provide tools that enable the pharmaceutical scientist to act decisively in an uncertain world. An understanding of basic statistical methods is important for all who work in the pharmaceutical field. 

NIRS has proven to be a fast, reliable, and cost-saving method for numerous applications in the pharmaceutical industry. It is no longer the esoteric method it was once believed to be. The pharmaceutical industry has learned a great deal about NIRS from the agricultural and food industries. Concepts and techniques have been borrowed and fitted to the needs of pharmaceutical scientists. Users in all disciplines face common issue, such as calibration transfer, moisture contamination, particle size, and the rigors of calibrating multiple constituents. 

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