Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

نویسندگان

چکیده

برای دانلود رایگان متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Formulation of a Traditional Polyherbal Product to a Standard Pharmaceutical Syrup and Development of Its Quality Control Methods

Background and objectives: People interest in traditional medicine has increased recently; however, traditional herbal medicines should be transformed into modern forms of medicine to increase patient acceptance. In this investigation, a polyherbal traditional combination “Monzej-e-balgham” has been based on according to Iranian traditional medicine (ITM) manuscripts and its qu...

متن کامل

Role of statistics in quality by design product development for pharmaceutical industry: a review

Pharmaceutical industry is showing a positive approach towards Quality by Design (QbD) for discovery, development, and commercial manufacturing of biopharmaceutical products. Regulatory agencies are providing various guidelines for pharmaceutical industry to build quality, safety and efficacy into their new biopharmaceutical products. Such concept became known as Quality by Design. To assess th...

متن کامل

development and implementation of an optimized control strategy for induction machine in an electric vehicle

in the area of automotive engineering there is a tendency to more electrification of power train. in this work control of an induction machine for the application of electric vehicle is investigated. through the changing operating point of the machine, adapting the rotor magnetization current seems to be useful to increase the machines efficiency. in the literature there are many approaches wh...

15 صفحه اول

Pharmaceutical “quality by design” approach

10.4103/japtr.JAPTR_343_17 Dear Friends, Based on quality risk management, the pharmaceutical quality by design (QbD) has been emerged as a logical methodology for the development which commences with prior delineated goals and accentuates better understanding of product and process control. The basis of QbD strategy is International Conference on Harmonization guidelines. QbD approach is surfa...

متن کامل

hydrochlorothiazide detection in urine samples by hplc-dad and experimental design dispersive l-l microextraction

hydrochlorothiazide (hct) is a diuretic agent which is shown to be effective in the treatment of hypertension. literature reports have demonstrated that urinary excretion data may be used to assess the bioavailability of various formulations containing this thiazide. also hct consumption by the athletes is one of the drugs which should be regulated by world anti-doping agency (wada), because of...

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

ژورنال

عنوان ژورنال: Pharmaceutical Research

سال: 2008

ISSN: 0724-8741,1573-904X

DOI: 10.1007/s11095-008-9667-3