Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products

Raw, Andre; Lionberger, Robert; Yu, Lawrence X.

doi:10.1007/s11095-011-0397-6

Cited by 36 publications

(17 citation statements)

References 12 publications

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“…Consequently, the lack of a well-defined QTPP has resulted in wasted time and valuable resources. A recent paper by Raw et al (12) illustrates the significance of defining the correct QTPP before conducting any development. Also, QbD examples exemplify the identification and use of QTPPs (20)(21)(22).…”

Section: Elements Of Pharmaceutical Quality By Designmentioning

confidence: 99%

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Understanding Pharmaceutical Quality by Design

Amidon

Khan

et al. 2014

AAPS J

Self Cite

989

531

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Abstract. This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.

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Section: Elements Of Pharmaceutical Quality By Designmentioning

confidence: 99%

“…There is confusion among industry scientists, academicians, and regulators despite recent publications (10)(11)(12)(13). This paper is intended to describe the objectives of pharmaceutical QbD, detail its concept and elements, and explain implementation tools and studies.…”

Section: Introductionmentioning

confidence: 99%

Understanding Pharmaceutical Quality by Design

Amidon

Khan

et al. 2014

AAPS J

Self Cite

989

531

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“…2) при изучении биоэквивалентности рассмат ривается действие разовых доз препаратов, при ре гулярном применении параметры фармакокинети ки, по крайней мере некоторых препаратов, могут существенно меняться [8];…”

Section: шаг 3 сравнение дженерических версий препара-тов представлunclassified

An algorithm for the rational choice of a drug for the treatment of infections in rhinology. What should be preferred: a brand-name or generic antibiotic?

Dukhanin¹

2016

Ross. rinol.

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Увеличение числа дженерических (воспроизве денных) препаратов, связанное с утратой патентной защиты на оригинальные лекарственные препараты (ЛП), неизбежно ставит врача перед проблемой вы бора: назначить оригинальную или дженерическую версию ЛП и какой препарат из длинного ряда дже нериков предпочесть.В медицинской литературе часто мы встречаем всего 2 полярных мнения: одни авторы отдают пред почтение оригинальным антимикробным препара там, не отмечая различий в качестве различных дже нерических ЛП [1], другие представляют интересы отдельных производителей дженерических форм, не приводя убедительных научных аргументов их пре имуществ над оригинальными средствами [2].С одной стороны, оригинальный препарат име ет несомненные достоинства, так как вся доказа тельная база клинических исследований собрана с использованием именно такого ЛП. Убедиться в на личии такой базы, получить полную информацию по каждому клиническому исследованию с приме нением препарата можно на специализированном сайте wwww.clinicaltrials.gov. Здесь в открытом бес платном доступе приведена подробная информация о цели и задачах исследования, критериях включе ния/исключения, описаны конечные точки, резуль таты исследования. На данном Интернетресурсе представлены все значимые клинические исследо вания за последние 20 лет (всего около 36 000).С другой стороны, использование качествен ных и чаще всего более дешевых, чем оригинальные бренды, препаратовдженериков существенно со кращает затраты на здравоохранение и одновре менно способствует более широкому внедрению современных клинических рекомендаций по ис The paper discusses the interchangeability of generic and brand-name drugs, the study of (pharmaceutical, pharmacokinetic) equivalence, and possible methodical difficulties in its estimation. It presents the new requirements of federal legislation on the recognition of drug interchangeability and proposes criteria for a good-quality generic drug, as well as an algorithm for comparative analysis of the main characteristics of brand-name and generic drugs, by using the systemic antibiotic levofloxacin from a group of fluoroquinolones as an example.

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“…Bioequivalence requires a statistical equivalence in the rate and extent of drug release available at the site of action. Drugs are considered to be therapeutically equivalent which are both pharmaceutically equivalent and bioequivalent (43).…”

Section: Bioequivalence and The Clinical Development Of Pediatric Formentioning

confidence: 99%

A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

Zajicek

Fossler

Barrett

et al. 2013

AAPS J

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Abstract. Despite the fact that a significant percentage of the population is unable to swallow tablets and capsules, these dosage forms continue to be the default standard. These oral formulations fail many patients, especially children, because of large tablet or capsule size, poor palatability, and lack of correct dosage strength. The clinical result is often lack of adherence and therapeutic failure. The American Association of Pharmaceutical Scientists formed a Pediatric Formulations Task Force, consisting of members with various areas of expertise including pediatrics, formulation development, clinical pharmacology, and regulatory science, in order to identify pediatric, manufacturing, and regulatory issues and areas of needed research and regulatory guidance. Dosage form and palatability standards for all pediatric ages, relative bioavailability requirements, and small batch manufacturing capabilities and creation of a viable economic model were identified as particular needs. This assessment is considered an important first step for a task force seeking creative approaches to providing more appropriate oral formulations for children.

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Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products

Cited by 36 publications

References 12 publications

Understanding Pharmaceutical Quality by Design

Understanding Pharmaceutical Quality by Design

An algorithm for the rational choice of a drug for the treatment of infections in rhinology. What should be preferred: a brand-name or generic antibiotic?

A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

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