Nebulizer – In vitro Bioequivalence testing requirements: A review

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

In vitro bioequivalence testing.

A statistical test is proposed for in vitro bioequivalence testing between drug products such as nasal aerosols and nasal sprays. The proposed test generalizes the one recommended in the FDA 1999 guidance to the situation where replicated observations obtained from each sampled canister or bottle of the drug product are available. The technique developed by Hyslop, Hsuan and Holder is used so t...

متن کامل

Nebulizer efficiency: modeling versus in vitro testing.

s from 953 Other Journals Advertisers Index 1096 & Help Lines

متن کامل

In vivo and In vitro Bioequivalence Testing

For approval of generic drug products, bioequivalence testing is considered as a surrogate for clinical evaluation of the therapeutic equivalence of drug products based on the Fundamental Bioequivalence Assumption that when two drug products (e.g., a brand-name drug and its generic copy) are equivalent in bioavailability, they will reach the same therapeutic effect. Although bioavailability for...

متن کامل

Nebulizer testing

Two major factors affect drug delivery with nebulizers: usage time and droplet size. Unlike other inhalation devices, nebulizers provide continuous delivery instead of a pre-metered dose of drug. Once loaded and activated, a nebulizer operates with the user breathing normally so that the patient’s breathing profile and usage time determine the amount of drug received. As with other inhalation p...

متن کامل

Bioequivalence and Bioequivalency Testing

PROLOGUE This lecture material is covered in one and one-half fiftyminute lecture periods. The primary objectives of the lecture are to: (i) review interpatient and intrapatient pharmacokinetic variability; (ii) introduce the concepts of therapeutic equivalence and bioequivalence; (iii) introduce the current FDA standards on bioequivalence; (iv) introduce the basic approach of bioequivalency te...

متن کامل

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: Asian Journal of Pharmaceutical Research and Development

سال: 1970

ISSN: 2320-4850

DOI: 10.22270/ajprd.v8i1.647