Recommendations on the procedure for determining the interchangeability of medicinal products

Recommendations on the procedure for determining the interchangeability of medicinal products

The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for a...

Full description

Bibliographic Details
Main Authors:	B. K. Romanov, N. D. Bunyatyan, Yu. V. Olefir, V. P. Bondarev, A. B. Prokofyev, R. I. Yagudina, R. N. Alyautdin, E. L. Kovaleva, A. P. Pereverzev, K. E. Zatolochina, A. S. Kazakov, A. V. Komratov, E. Yu. Pasternak
Format:	Article
Language:	Russian
Published:	NEICON ISP LLC 2018-02-01
Series:	Ведомости Научного центра экспертизы средств медицинского применения
Subjects:	рекомендации взаимозаменяемость лекарственное средство биоэквивалентность терапевтическая эквивалентность recommendation interchangeability medicinal product bioequivalence therapeutic equivalence
Online Access:	https://www.vedomostincesmp.ru/jour/article/view/31

Similar Items

Interchangeability of glibenclamide-containing drugs
by: G. I. Gorodetskaya, et al.
Published: (2018-02-01)

Interchangeability of levothyroxine sodium tablets
by: G. I. Gorodetskaya, et al.
Published: (2018-02-01)

Экономические преимущества и слабые стороны генериков в системе лекарственного обеспечения населения в России и за рубежом
Published: (2018-06-01)

Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs
by: E. O. Zhuravleva, et al.
Published: (2018-02-01)

On the interchangeability of calcineurine inhibitors
by: K. E. Zatolochina, et al.
Published: (2018-02-01)

Problems of interchangeability of systemic interferons for treatment of multiple sclerosis
by: I. I. Snegireva, et al.
Published: (2018-02-01)

The interchangeability of drugs from line items of pharmaceutical compliance and clinical efficiency and safety
by: N. V. Verlan, et al.
Published: (2018-05-01)

PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES
by: S. N. Tolpygina, et al.
Published: (2016-01-01)

Generic therapy: the problem of choice
by: S. N. Tolpygina
Published: (2009-06-01)

Modern approaches to vaccines interchangeability
by: I. I. Snegireva, et al.
Published: (2018-02-01)

TREATMENT OF OSTEOPOROSIS: CLINICAL EXPERIENCE IN USING A GENERIC DRU
by: Nataliya Vladimirovna Toroptsova, et al.
Published: (2011-03-01)

ДЖЕНЕРИЧЕСКИЕ СТАТИНЫ В КЛИНИЧЕСКОЙ ПРАКТИКЕ: ДЕШЕВЫЕ ЗАМЕНИТЕЛИ ИЛИ ДОСТОЙНАЯ АЛЬТЕРНАТИВА БРЕНДАМ. АТОРВАСТАТИН
by: В. П. Михин, et al.
Published: (2012-04-01)

EXPRESS METHOD FOR DETERMINATION OF ENALAPRIL AND ENALAPRILAT IN HUMAN SERUM BY HPLC-MS/MS
by: T. A. Rodina, et al.
Published: (2019-01-01)

Checking and correction of drug information in the standards of care and clinical guidelines
by: B. K. Romanov
Published: (2018-02-01)

Recommendations for evaluating the safety of medicinal products containing nanoparticles
by: R. N. Alyautdin, et al.
Published: (2018-02-01)

Guidelines for the planning and implementation of pharmacovigilance systems audit
by: S. V. Glagolev, et al.
Published: (2018-02-01)

Highly variable medicines - specific aspects of bioequivalence studies
by: D. P. Romodanovsky, et al.
Published: (2018-02-01)

INTERCHANGEABILITY OF VIRAL VACCINES FOR IMMUNIZATION
by: I. I. Snegireva, et al.
Published: (2017-10-01)

IMPROVING THE SYSTEM OF REGISTRATION OF MEDICINES IN RUSSIAN FEDERATION
by: A. G. Tsyndymeyev, et al.
Published: (2019-01-01)

SELECTIVE PROPHYLAXIS OF RHINO-SINUSITIS IN CHILDREN WITH ACUTE RESPIRATORY VIRAL INFECTION
by: Tamara Aleksandrovna Mashkova, et al.
Published: (2012-03-01)

PREDICTION OF THE INFLUENCE OF ORIGINAL AND GENERIC ROSUVASTATIN ON DIRECT MEDICAL COSTS OF SECONDARY PREVENTION IN PATIENTS WITH CHRONIC TYPES OF ISCHEMIC HEART DISEASE
by: E. I. Tarlovskaya, et al.
Published: (2015-08-01)

Guidelines for the Preparation of a Document Containing the Drug Safety Monitoring Results
by: Yu. V. Olefir, et al.
Published: (2018-02-01)

DEVELOPMENT AND VALIDATION OF A SPECTROFLUORIMETRIC METHOD FOR THE DETERMINATION OF PHENIBUT IN TABLET DRUGS
by: O. I. Lazovskaya, et al.
Published: (2019-01-01)

Properties and Prospects of Application of the Whey Protein Lactoferrin in Medicine and Veterinary Medicine (Review)
by: E. T. Zhilyakova, et al.
Published: (2022-02-01)

EFFICIENCY OF THE NEW MEDICATION OF FS-1 IN THE TREATMENT OF EXPERIMENTAL TUBERCULOSIS
by: M. E. Kulmanov, et al.
Published: (2015-12-01)

Control of adverse drug reactions in HIV/AIDS antiretroviral treatment with interchangeable medicines
by: M. V. Zhuravleva, et al.
Published: (2018-02-01)

Modern approaches to the assessment of orally inhaled products bioequivalence
by: E. S. Petrova, et al.
Published: (2018-02-01)

RESEARCH OF THE PREPARATION «AMINALON-FARMAK» ON THE PHARMACEUTICAL MARKET OF THE UKRAINE: INFORMATION REVIEW
by: V. A. Kuchmistov, et al.
Published: (2015-09-01)

Pitfalls of patenting and state authorization of medicines
by: V. I. Semenov, et al.
Published: (2018-02-01)

Interchangeability of Fluconazole Drugs
by: N. D. Bunyatyan, et al.
Published: (2018-12-01)

TERM EXTENSION OF DRUG PATENTS IN RUSSIA (REVIEW OF LEGISLATION AMENDMENTS)
by: K. V. Osipov
Published: (2019-01-01)

Vaccine interchangeability: problems and prospects
by: N. A. Gavrilova, et al.
Published: (2021-10-01)

Comparative study of perindopril and perindopril metabolite pharmacokinetics using the HPLC/MS method
by: L. M. Krasnykh, et al.
Published: (2018-02-01)

THE ROLE OF SMALL INNOVATIVE ENTERPRISES IN THE DEVELOPMENT AND MARKET LAUNCH OF INNOVATIVE DRUGS
by: A. A. Semin, et al.
Published: (2019-01-01)

Практические рекомендации для терапевтов по диагностике и лечению лекарственных поражений печени
by: Людмила Константиновна Пальгова, et al.
Published: (2022-02-01)

Generic drugs: benefit/risk ratio
by: E. A. Ushkalova, et al.
Published: (2021-12-01)

АНАЛИЗ ФАРМАКОЛОГИЧЕСКОЙ ТЕРАПИИ У ПАЦИЕНТОВ КАРДИОЛОГИЧЕСКОГО СТАЦИОНАРА С ЛЕКАРСТВЕННО-ИНДУЦИРОВАННЫМ СИНДРОМОМ УДЛИНЕННОГО ИНТЕРВАЛА QT
by: L. V. Kalatsei, et al.
Published: (2022-03-01)

Фармакокинетическое исследование биоэквивалентности ородиспергируемых таблеток феназепама
by: Гордеев, И.Г., et al.
Published: (2020-04-01)

A COMPARATIVE STUDY OF EFFICACY AND TOLERABILITY OF GENERIC AND ORIGINAL LOW-DOSE BISOPROLOL/HYDROCHLOROTHIAZIDE COMBINATION IN PATIENTS WITH ARTERIAL HYPERTENSION OF 1-2 DEGREES. RESULTS OF CLINICAL RANDOMIZED CROSSOVER STUDY
by: S. Yu. Martsevich, et al.
Published: (2015-09-01)

AN OVERVIEW OF THE MAIN CHANGES IN THE RULES OF GOOD LABORATORY PRACTICE (THE ORDER FROM 01 APRIL 2016 № 199n ENTERED INSTEAD OF THE ORDER OF MINISTRY OF HEALTH OF 23 AUGUST 2010 №708n)
by: M. S. Zhuravleva, et al.
Published: (2019-01-01)