Control of pharmaceutical

Pharmaceutical microbiology may be defined as that part of microbiology which has a special bearing on pharmacy in all its aspects. This will range fiom the manufacture and quality control of pharmaceutical products to an understanding of the mode of action of antibiotics. The full extent of microbiology on the pharmaceutical area may be judged fiom the chapter contents. 

ASEAN Regional Training Centre for QCL and WHO Collaborating Centre in the Regulatory Control of Pharmaceuticals. 

PUBLIC CONTROL OF PHARMACEUTICAL PRICES DOES NOT GUARANTEE LOWER PRICES WHEN THE PATENT EXPIRES... 

Co-payment is an instrument that should not be used on its own. Neither efficiency in drag use nor equity nor the control of pharmaceutical expenditure can rest solely on co-payment. Its effectiveness is reinforced when it is combined with other instruments and incentives. In fact, all European countries combine, in different doses and proportions, multiple instruments that influence the behaviour of the industry, prescribes and patients. It is sufficient to recall that pharmaceutical expenditure is the product of price by quantity, and to consider the enormous international variability of drag prices,35 in order to understand the limitations of co-payment regulation in comparison with other policies that influence prices. Policies aimed at price control can be as effective as co-payment - or more so - for purposes of cost containment. 

Cruz-Roche, I. (1986), Financiacion y control del gasto farmaceutico , in Direccion General de Farmacia y Productos Sanitarios uso racional y financiacion publica de los medicamentos en Europa, Madrid Ministerio de Sanidad y Consumo, pp. 151-73. (An English version is available entitled Cruz-Roche, I. (1984), Financing and control of pharmaceutical... 

Third, there was a considerable bureaucratic turf war over the control of pharmaceutical advertising. Finally, despite the efforts of the various lobbying groups, there was no popular interest or support for the bill. By the end of the congressional period, S.1944 had died for lack of passage. 

The National Institute for the Control of Pharmaceutical Biological Products (NICPBP) performs tests on the drug samples submitted. Based on the test results and the report from the CDE, the DDR approves the conduct of clinical trials at designated hospitals in China (Fig. 8.13). 

Korman, M., Vindevogel, J., and Sandra, P. (1994). Application of micellar electrokinetic chromatography to the quality-control of pharmaceutical formulations — the analysis of xanthine derivatives. Electrophoresis 15, 1304—1309. 

G. Fevotte, In situ Raman spectroscopy for in-fine control of pharmaceutical crystallization and solids elaboration processes a review, Chem. Eng. Res. Des., 85, 906-920 (2007). 

A.S. El-Hagrasy, F.D Amico and J.K. Drennen III, A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part I D-optimal design for characterization of powder mixing and preliminary spectral data evaluation, J. Pharm. Sci, 95(2), 392 06 (2006). 

O. Bemtsson, G. Zackrisson and G. Ostling, Determination of moisture in hard gelatin capsules using near-infrared spectroscopy applications to at-line process control of pharmaceutics, J. Pharm. Biomed. Anal, 15, 895-900 (1997). 

P. Corti, E. Dreassi, C. Murratzu, G. Corbini, L. Ballerini and S. Gravina, Application of NIRS to the quahty control of pharmaceuticals. Ketoprofen assay in different pharmaceutical formulae, Pharmaceutica Acta Helvetiae, 64, 140-145 (1989). 

Extensive use has been made of NIRA in agriculture where it has been used to determine the protein, fibre, water and triglyceride contents of feedstuffs and the quality of crops. By training the computer to recognise the near-infrared (NIR) spectra of the major components making up a crop, the individual components can be monitored in the crop itself. The components that can be measured by NIRA often cannot be measured by the usual spectroscopic methods. The fundamental work done in the quality control of agricultural products can be readily extended to the quality control of pharmaceutical formulations. 

There are many GC detectors available although the flame ionisation detector remains the most widely used and the most widely applicable to quality control of pharmaceutical products. However, newer detectors such as the plasma emission detector for analysis of trace impurities or the GC-FTIR detector for the structural characterisation of components in mixtures are becoming increasingly important. 

The longest chapter deals with high-pressure liquid chromatography, which is the most widely used technique for the quality control of pharmaceuticals and which could fill several books until one realises that many analyses are based on a few... 

Blanco, M. Coello, J. Eustaquio, A. etal., Analytical control of pharmaceutical production steps by near infrared reflectance spectroscopy Anal. Chim. Acta 1999, 392, 237-246. 

Specifications for the Quality Control of Pharmaceutical Preparations", 2nd Ed., World Health Organization,... 

The quality control of pharmaceuticals is particularly important. Care must be taken to limit the levels of toxic metals in the final product. The acid dissolution. procedures described above (e.g. 6 M hydrochloric acid) are often equally applicable for the determination of impurities. Complete destruction of the matrix by wet oxidation or dry ashing may be necessary to obtain a completely independent method. Raw materials, catalysts, preparative equipment and containers are all possible sources of contamination. Lead, arsenic, mercury, copper, iron, zinc and several other metals may be subject to prescribed limits. Greater sensitivity is often required for lead and arsenic determinations and this can be achieved by electrothermal atomisation. Kovar etal. [112] brought samples into solution using 65% nitric acid under pressure at 170—180° C and, after adding ammonium and lanthanum nitrate, determined arsenic in the range 10—200 ng in a graphite... 

TABLE 4 Analytical Methods for Characterization and Quality Control of Pharmaceutical Peptides and Proteins... 

Gilg, D., Riedl, B., Zier, A., and Zimmermann, M. F. (1996), Analytical methods for the characterization and quality control of pharmaceutical peptides and proteins, Pharm. Acta Helv., 71, 383-394. 

Sarri, A.K., Megoulas, N.C., and Koupparis M.A. Development of novel hquid chromatography evaporative hght scattering detection method for bacitracins and apphcations to quality control of pharmaceuticals. Arwl. Chim. Acta 2006, 573-574, 250-257. 

Japanese Ministry of Health and Welfare (1997), Regard to Retention of Records by Using Magnetic Media, Concerning Manufacturing Control and Quality Control of Pharmaceutical Products and Medical Devices, Open Letter to Every Prefectural Health Lead Officer, Inspection Guidance Division of Pharmaceutical and Medical Safety Bureau, September 18. 

Ar)me et al. [26] presented rapid liquid chromatographic procedures for quality control of pharmaceuticals and human serum containing antihistamines, meclizine, and buclizine alone or in combination with pyri-doxine using acetonitrile water (80 20) as a mobile phase (pH adjusted to 2.6), methylparaben as internal standard deviation and UV detection was made at 230 nm. The results obtained showed a good agreement with the declared content. The method had good linearity in the range of 0.03-10 pg/ml for pyridoxine and (0.025-10 pg/ml) for meclizine and buclizine serum concentration with a correlation coefficient of 0.9999. 

Fujiwara, M. Nagy, Z.K. Chew, J.W. Braatz, R.D. First-principles and direct design approaches for the control of pharmaceutical crystallization. J. Proc. Control 2005, 15 (5), 493-504. 

For analytical control of pharmaceuticals, most pharmacopeias describe accurate methods, which, however, in some cases are lengthy and difficult. The ion-selective electrode techniques offer several advantages in terms of simplicity and rapidity over official methods. Generally, electrodes of all the types noted above can be used to analyze compounds of pharmaceutical... 

---