Clinical comparability

Sharp, W, Walter, J., Marsh, W., Ritchie, G., Hamburger, S., and Castellanos, X. (1999) ADHD in girls clinical comparability of a research sample. J Am Acad Child Adolesc Psychiatry 38 40-47. 

Some direct comparisons of DPI and MDI for the same drug have been made in the interest of developing alternative but comparable products for patients. The therapeutic performance of inhalation delivery systems is as dependent on the patient as it is on the product itself. Therefore, some demonstration of clinical comparability is generally required to support product substitution. 

All of the above mentioned dosage forms may be utilized in clinical trials as the developed product or as a clinical comparator. Clinical comparators ... 

Fig. 4 Typical activities in the development of blinded clinical comparators.

A non-invasive NIR method was reported by Dempster et for the identification of tablets within blister packages. The method identified and discriminated various potencies of an experimental drug, placebo tablets, and clinical comparator tablets. 

Using the first configuration, all but the 2% tablets were easily classified the 2% tablets could not be differentiated from placebo samples. With the second and third configurations, only 10 and 20% tablets, placebo, and clinical comparator tablets could be properly classified. 

Fries SM. Diagnosis of group A streptococcal pharyngitis in a private clinic comparative evaluation of an optical immunoassay method and culture. J Pediatr 1995 126 933-6. 

I 1. Shaffer, J. Wexlcr, L.F. Reducing low-density lipoprotein cholesterol in an ambulatory care system. Results of a mullidisciplinary collaborative practice lipid clinic compared with traditional physician-based care. Arch. Intern. Med. 1995, 155, 2330-2335. 

The ICSs beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate, and triamcinolone acetonide that are currently available for use are compared and listed in Table 26-12. The ICSs have pharmacokinetic differences that result in different topical/ systemic activity. Most evidence is consistent with log-linear dose-response curves for both indirect and direct responses. The log-linear nature of the dose-response curve for corticosteroid activity raises the issue of how much of a difference in dose (or lung delivery) or potency is detectable. The dose-response curves for the ICSs are relatively flat primarily because all the measures used to assess efficacy (lung function, BHR, symptoms, and as-needed short-acting inhaled /32-agonist use) are downstream events from the anti-inflammatory activity. In general, it takes a fourfold difference in potency or dose to detect clinically significant differences. The table of comparative doses (see Table 26-12) is based on extensive comparative clinical trials. Clinical comparative doses take into consideration potency differences as well as lung delivery differences from the various devices. 

Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg 2004 53 132-136. 

As a result, another omeprazole-based PPI lansoprazole has been developed successfully and marketed in 1991. Both pantoprazole and lansoprazole have showed lower oral clearance and longer plasma half-life in clinic compared to omeprazole or esomeprazole due to improved enzymatic stability and solution stability [71]. 

Fink C, Hallscheidt PJ, Noeldge G, Kampschulte A, Radeleff B, Hosch WP, Kaufman n GW, Hansmann J (2002) Clinical comparative study with a large-area amorphous silicon flat-panel detector image quality and visibility of anatomic structures on chest radiography. AJR Am J Roentgenol 178 481-486... 

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