INTRODUCTION . Kinetic bacterial endotoxin (BE) testing methods based on amoebocyte lysate from the haemolymph of horseshoe crab can quantify BEs in parenteral medicinal products across a broad range concentrations. To develop specific analytical procedure that is these and be implemented into pharmaceutical quality control standardisation, it required to ascertain conditions for its use, particular, determine lowest product dilution would neutralise interfering factors. AIM This study aimed...

INTRODUCTION . Raw materials of biological origin can contaminate medicines with depressor substances, such as histamine, acetylcholine, bradykinin, serotonin, and prostaglandins. In the Russian Federation, tests for content these impurities are conducted in anaesthetised healthy cats accordance General Chapter Test substances State Pharmacopoeia Federation. The global trend towards ending animal testing search ways to eliminate motivate researchers study international approaches...

INTRODUCTION. The tendency towards reducing the use of laboratory animals in pharmaceutical quality assessment, along with development new technologies for gonadotrophin production, necessitate novel assays to determine biological activity natural and recombinant anterior pituitary preparations. AIM. This study aimed select optimum conditions determination luteinising hormone (LH) urinary genetically engineered LH preparations by tests randombred Sprague Dawley rats. MATERIALS AND METHODS....

The paper considers insulin’s specific action on the patient’s body, types of insulin preparations and analogues which are used for treatment diabetes, as well applicable requirements these products. It was demonstrated that determination biological activity is one key quality parameters this type medicines. summarises methods evaluation its analogues, based both hormone’s general body ( in vivo : double crossing, euglycemic clamp, etc.), certain aspects interaction with systems vitro...

For over 60 years, the Abnormal Toxicity Test (ATT) has been used as an important tool in safety control of some parenteral and veterinary products made from biological materials. In 2017, members Pharmacopoeial Committee Eurasian Economic Union (EAEU) proposed not to include ATT draft monographs EAEU Pharmacopoeia based on decision European Commission suppress test. However, this may be achieved Russia at point, because production sites that manufacture medicinal for human use have fully...

In order to harmonise national and foreign requirements for quality control of medicinal products, a second variant the test method, which complies with European Pharmacopoeia, was included into general monograph OFS.1.2.4.0008.18 “Test depressor substances”. The aim study compare two variants in vivo method that uses cats determination substances products develop recommendations use these method. comparative analysis ways determining impurities lower blood pressure revealed different...

The median lethal dose (LD 50 ) and low 10 are calculated in acute toxicity studies, as well during specific activity assessment of some medicines. aim the study was to develop a procedure for using CombiStats calculate LD . authors proposed step-by-step algorithm processing bioassay results biometric software (median effective determination model, probit analysis) with conversion doses simple fractions (fractions maximum dose) They compared calculation obtained those electronic spreadsheets...

Scientific relevance. The biological activity of medicinal products may vary depending on the method production (i.e. or recombinant products). widening variety gonadotrophin preparations, diversity their methods, and irreplaceability bioassays with physicochemical tests require improvement animal testing conditions. Aim. This study aimed to determine follicle-stimulating hormone (FSH) in several rat lines, analyse findings, select most optimal Materials methods. was determined using vivo...

Multiple sclerosis is a chronic, widespread neurodegenerative disease, which accompanied by considerable degree of disability and requires lifelong drug therapy. In this regard, the relevant objective for production generic drugs treating multiple sclerosis, so-called generics, to ensure their quality be at level original forms. This article provides an overview methods determining comparability generics major groups medications used in treatment sclerosis: glatiramer acetate preparations,...

Multiple sclerosis is a chronic, widespread neurodegenerative disease, which accompanied by considerable degree of disability and requires lifelong drug therapy. In this regard, the relevant objective for production generic drugs treating multiple sclerosis, so-called generics, to ensure their quality be at level original forms. This article provides an overview methods determining comparability generics major groups medications used in treatment sclerosis: glatiramer acetate preparations,...