Biowaiver study of atenolol

Biowaiver Studies of Atenolol Tablets (100mg) - An ...

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Biowaiver Studies of Atenolol Tablets (100mg) - An Alternative to In Vivo Bioequivalence Studies Abstract.

Biowaiver Studies of Atenolol Tablets (100mg) - An ...

Waiver of In Vivo Bioavailability and Bioequivalence ...

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1005598 FNL . Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification

Waiver of In Vivo Bioavailability and Bioequivalence ...

Biowaiver Studies of Atenolol Tablets (100mg) - An ...

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The aim of present study was to compare the quality of atenolol tablets and examine the possibility of biowaiver study for approval of generic drugs without additional in vivo bioequivalence study. Atenolol, a cardio selective β-blocker, could be clearly classified into BCS Class III and may be evaluated under biowaiver conditions. Due to the importance of atenolol and availability of ...

Biowaiver Studies of Atenolol Tablets (100mg) - An ...

Biowaiver Studies of Atenolol Tablets (100mg) - An ...

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Biowaiver Studies of Atenolol Tablets (100mg) - An ...

Biowaiver Studies of Atenolol Tablets (100mg) - An ...

Biowaiver Studies of Atenolol Tablets Mg an Alternative to ...

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Biowaiver Studies of Atenolol Tablets Mg an Alternative to in Vivo Bioequivalence Studies 2329 6836.1000125

Biowaiver Studies of Atenolol Tablets Mg an Alternative to ...

Biowaiver Studies of Atenolol Tablets ( 100 mg )-An ...

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The aim of present study was to compare the quality of atenolol tablets and examine the possibility of biowaiver study for approval of generic drugs without additional in vivo bioequivalence study. Atenolol, a cardio selective β-blocker, could be clearly classified into BCS Class III and may be evaluated under biowaiver conditions.

Biowaiver Studies of Atenolol Tablets ( 100 mg )-An ...

Biowaiver Studies of Atenolol Tablets (100mg) - An ...

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Download Citation on ResearchGate | On Jan 1, 2014, Shahnaz Usman and others published Biowaiver Studies of Atenolol Tablets (100mg) - An Alternative to In Vivo Bioequivalence Studies

Biowaiver Studies of Atenolol Tablets (100mg) - An ...

Biowaiver monographs for immediate release solid oral ...

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Biowaiver monographs for immediate release solid oral dosage forms based on Biopharmaceutics Classification System (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and ...

Biowaiver monographs for immediate release solid oral ...

Biowaiver Studies of Atenolol Tablets Mg an Alternative to ...

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The aim of present study was to compare the quality of atenolol tablets and examine the possibility of biowaiver study for approval of generic drugs without additional in vivo bioequivalence study. Atenolol, a cardio selective β-blocker, could be clearly classified into BCS Class III and may be evaluated under biowaiver conditions.

Biowaiver Studies of Atenolol Tablets Mg an Alternative to ...

Biowaiver monographs for immediate release solid oral ...

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A biowaiver implies that bioequivalence (BE) assessment studies are waived for marketing authorizations (MA) by Health Authorities for a new tablet or capsule, or a new formulation of an existing immediate release (IR) dosage form, and hence the product is considered bioequivalent to its reference product, without carrying out a BE study.

Biowaiver monographs for immediate release solid oral ...

The Biowaiver Extension for BCS Class III Drugs: The ...

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The Biopharmaceutical Classification System (BCS) guidance issued by the FDA allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release (IR) solid oral dosage forms only for BCS class I drugs. However, a number of drugs within BCS class III have been proposed to be eligible for biowaivers. The World Health Organization (WHO) has shortened the requisite ...

The Biowaiver Extension for BCS Class III Drugs: The ...

PROPOSAL TO WAIVE IN VIVO BIOEQUIVALENCE REQUIREMENTS …

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Biowaiver Approval of a generic oral solid formulation of an API based on strictly defined dissolution criteria as a surrogate for an in vivo bioequivalence test (provided other aspects of the dossier are deemed acceptable according to the usual criteria).

PROPOSAL TO WAIVE IN VIVO BIOEQUIVALENCE REQUIREMENTS …

Biowaiver monographs for immediate release solid oral ...

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biowaiver can berecommended forIRsolidoraldosage formsthat are rapidly dissolving and contain only those excipients as reported inthis study. 2005Wiley-Liss,Inc.andthe American Pharmacists Association J Pharm Sci 94:1617–1625, 2005 ... atenolol, and propranolol were used as reference compounds.

Biowaiver monographs for immediate release solid oral ...

COMMENTARY Biowaiver Monographs for Immediate Release ...

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COMMENTARY Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Amitriptyline Hydrochloride R.H. MANZO, 1M.E. OLIVERA, ... the aims of the present study are to evaluate all pertinent data available from literature sources to assess the appropriateness of such a biowaiver

COMMENTARY Biowaiver Monographs for Immediate Release ...

Biowaiver monographs for immediate release solid oral ...

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A biowaiver implies that bioequivalence (BE) assessment studies are waived for marketing authorizations (MA) by Health Authorities for a new tablet or capsule, or a new formulation of an existing immediate release (IR) dosage form, and hence the product is considered bioequivalent to its reference product, without carrying out a BE study. In ...

Biowaiver monographs for immediate release solid oral ...

The biowaiver extension for BCS class III drugs: the ...

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8/2/2010 · The biowaiver extension for BCS class III drugs: the effect of dissolution rate on the bioequivalence of BCS class III immediate-release drugs predicted by computer simulation. Tsume Y(1), Amidon GL. Author information: (1)College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109-1065, USA.

The biowaiver extension for BCS class III drugs: the ...

WHO Drug Information

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Concept paper for comment WHO Drug Information Vol. 30, No. 1, 2016 4 Pre-publication draft - page numbers are not for citation purposes affect the feasibility of the manufacturing process, including packaging and quality control testing, but also the overall quality assurance system of …

WHO Drug Information

Biowaiver Monographs for Immediate-Release Solid Oral ...

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A monograph based on the literature data is presented for nifedipine with respect to its biopharmaceutical properties. The purpose and scope of these monographs have been discussed previously. 1 To illustrate the various considerations that are used to determine whether the biowaiver procedure can be recommended or not, biowaiver monographs for active pharmaceutical ingredients (APIs ...

Biowaiver Monographs for Immediate-Release Solid Oral ...

COMMENTARY Biowaiver Monographs for Immediate Release ...

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can be made as to whether a biowaiver is advisable or not. This systematic approach to recommend or advise against a biowaiver decisions is referred to in the recently published World Health Organization (WHO) Guideline.2 Biowaiver monographs have already been pub-lished for acetaminophen (INN: paracetamol),3 amitriptyline,4 atenolol,1 ...

COMMENTARY Biowaiver Monographs for Immediate Release ...

ASSESSMENT OF PHARMACEUTICAL QUALITY CONTROL AND IN …

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ASSESSMENT OF PHARMACEUTICAL QUALITY CONTROL AND IN VITRO EQUIVALENCE OF VARIOUS BRANDS OF ATENOLOL (100MG) TABLETS AVAILABLE IN SUDANESE MARKET UNDER BIOWAIVER CONDITIONS. Abdelrhman Abdelkarim 1*, Abdelkarim Mohammed 1 and Mohammed Abdeen 2 R&D Deputy Manager, Azal Pharmaceutical Co. LTD Khartoum, Sudan

ASSESSMENT OF PHARMACEUTICAL QUALITY CONTROL AND IN …

Biopharmaceutics Classification System: A Regulatory Approach

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The Biopharmaceutics Classification System (BCS) is the result of continuous efforts in mathematical analysis for the ... the biowaiver principle was extended to the approval of new generic drug products. As a result, unnecessary ... acyclovir, neomycin B, atenolol, and captopril. Class IV The drugs of this class are problematic for effective ...

Biopharmaceutics Classification System: A Regulatory Approach
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