Titlebook: Biopharmaceutics Applications in Drug Development; Rajesh Krishna,Lawrence Yu Book 2008 Springer-Verlag US 2008 absorption.bioequivalence.

词根词缀法

Christian Werner,Volker Klein,Konradin Weberds has become one of the most important tests in drug product development and manufacturing, as well as in regulatory assessment of drug product quality. Not only can dissolution testing provide information regarding the rate and extent of drug absorption in the body, it can also assess the effects

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虚假

接合

H. J. Kölsch,P. Rairoux,J. P. Wolf,L. Wösteliver the drug at the right place at the right time and with the right dose with the optimal delivery characteristics. Basically, an excipient has to fulfill the same safety profile as a drug with the exception that it should not exert a therapeutic effect. Most excipients do comply with these requi

NOMAD

Herbert Schneckenburger,Werner Schmidtinitial stages of drug discovery, numerous studies are performed to assess the pharmacological effectiveness of new chemical entities (NCEs) to select a lead compound(s) that offers the greatest promise for therapeutic efficacy. While the ability of a drug to bind to a therapeutic target is critical

notion

R. Bombach,B. Hemmerling,W. Kreutnerug absorption have been discussed in previous chapters. This chapter will cover general methods to evaluate bioavailability and bioequivalence. Scientific principles as well as regulatory perspectives related to these two topics will be discussed. Historically, the development of sensitive and preci

装勇敢地做

https://doi.org/10.1007/978-3-662-08252-2is a required performance test by many regulatory authorities for solid oral dosage forms, transdermal patches, stents, and oral suspensions. Dissolution testing is unique in that it is the only finished product test method in routine use that measures the effect of the formulation and physical prop

idiopathic

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H. G. Dahn,W. Lüdeker,K. P. Güntherssolution. Biological properties such as .max, or AUC have been used to correlate with . dissolution behavior such as percent drug release in order to establish IVIVC. IVIVC can be used to set product dissolution specifications; and as a surrogate for . bioequivalence in the case of any changes with

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B. Fuchs,H.-P. Berlien,G. Müller,W. Gorischrally administered drug products, it is usually a correlation between the extent or rate of dissolution of a dosage form and its pharmacokinetic parameters, such as rate, duration, and extent of drug absorption. The physicochemical properties of dosage forms influence their . performance in many dif