scholarly journals Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency

2021 ◽  
Vol 8 ◽  
Author(s):  
Laura Patricia Orellana García ◽  
Falk Ehmann ◽  
Philip A. Hines ◽  
Armin Ritzhaupt ◽  
Angela Brand
Keyword(s):  
Medicinal Product ◽  
Patient Selection ◽  
European Medicines Agency ◽  
Medicinal Products ◽  
Patient Identification ◽  
Levels Of Detail ◽  
European Public ◽  
Biomarker Testing ◽  
Selection For

Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may be required. The information and recommendations of use of a medicinal product for which a CDx is required is particularly important to healthcare professionals for correct patient identification.Methods: We reviewed the existing information in SmPCs and European Public Assessment Reports (EPARs) of EU medicinal products approved via the centralised procedure at EMA where reference was made to biomarker testing, including by CDx, for patient selection.Results: The results show that varying levels of detail are provided for the biomarker and the diagnostic test, including variability in where the information was presented. The overall results demonstrate transparent but sometimes heterogeneous reporting of CDx in the SmPC and EPAR.Conclusions: With the introduction of the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices, medicines regulatory authorities' will be required to be consulted during the review of CDx conformity assessment and so, there is opportunity for more consistent and transparent information on CDx to be provided in the SmPC and EPAR.

scholarly journals Measures to minimize cross-contamination risks in Advanced Therapy Medicinal Product manufacturing

2014 ◽  
Author(s):  
Livia Roseti ◽  
Marta Serra ◽  
Brunella Grigolo
Keyword(s):  
Medicinal Product ◽  
Main Product ◽  
Good Manufacturing Practice ◽  
Cross Contamination ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Product ◽  
Advanced Therapy ◽  
European Regulations ◽  
Product Manufacturing

Current European regulations define in vitro expanded cells for clinical purposes as substantially manipulated and include them in the class of Advanced Therapy Medicinal Products to be manufactured in compliance with current Good Manufacturing Practice. These quality requirements are generally thought to be elaborate and costly. However they ensure three main product characteristics: safety, consistency and absence of cross-contamination. The term cross-contamination is used to indicate misidentification of one cell line or culture by another. The Good Manufacturing Practice Guidelines suggest some recommendations in order to prevent cross-contaminations and require a demonstration that the implemented actions are effective. Here we report some practical examples useful both to minimize cross-contamination risks in an Advanced Therapy Medicinal Product production process and to evaluate the efficacy of the adopted measures.

scholarly journals Current Approaches to Demonstration of Therapeutic Equivalence of Locally-Acting Gastrointestinal Drugs

2021 ◽  
Vol 11 (4) ◽  
pp. 228-238
Author(s):  
E. V. Gorbunova ◽  
D. V. Goryachev ◽  
T. E. Gorskaya ◽  
A. N. Bogdanov
Keyword(s):  
Russian Federation ◽  
Methodological Approach ◽  
Test Methods ◽  
Careful Consideration ◽  
European Medicines Agency ◽  
Special Focus ◽  
Therapeutic Equivalence ◽  
Medicinal Products ◽  
The Russian Federation

Evolution of knowledge about pharmacokinetics and pharmacodynamics of locally acting products, and an increase in the number of generics and medicines under development have laid the ground for the development of new scientific approaches to planning and conducting of therapeutic equivalence studies of medicinal products acting locally in the gastrointestinal (GI) tract. To date, many international guidelines on planning and conducting of bioequivalence (BE) studies of locally acting GI products have been updated, however, there are still no such guidelines in the Russian Federation and the Eurasian Economic Union (EAEU). Therefore, elaboration of common methodological approaches to the planning of clinical studies of these products is of particular relevance for the EAEU. The aim of the study was to analyse foreign approaches to planning, conducting, and evaluation of therapeutic equivalence studies of locally acting GI products. The paper analyses the guidelines of the European Medicines Agency and the US Food and Drug Administration on the planning, conduct, and evaluation of BE studies of locally acting GI products. The analysis demonstrated that BE clinical trials are giving way to in vitro studies providing a sensitive and accurate assessment of the differences between a locally acting GI product and the reference product, based on careful consideration of the medicine’s mechanism of action, dosage form, and site of action. The paper gives examples of test methods applied to medicinal products with a complex biopharmaceutical profile whose bioequivalence assessment is challenging, with a special focus on mesalazine products. The results of the analysis may be used for elaboration of a harmonised methodological approach to planning and conducting therapeutic equivalence studies of locally acting GI products in the Russian Federation and EAEU.

scholarly journals Regulatory Perspectives of Pyrrolizidine Alkaloid Contamination in Herbal Medicinal Products

Planta Medica ◽  
2021 ◽  
Author(s):  
Jacqueline Wiesner
Keyword(s):  
Animal Studies ◽  
Pyrrolizidine Alkaloids ◽  
Pyrrolizidine Alkaloid ◽  
European Medicines Agency ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal ◽  
National Competent Authorities

AbstractThe toxicity of plants containing certain pyrrolizidine alkaloids has long been recognized in grazing animals and humans. Genotoxicity and carcinogenicity data from in vitro and in vivo (animal) studies were published over the last few decades for some of the 1,2-unsaturated pyrrolizidine alkaloids, leading to regulatory action on herbal medicinal products with pyrrolizidine alkaloid-containing plants more than 30 years ago. In recent years, it has become evident that in addition to herbal medicinal products containing pyrrolizidine alkaloid-containing plants, these products may also contain pyrrolizidine alkaloids without actually including pyrrolizidine alkaloid-containing plants. This is explained by contamination by accessory herbs (weeds). The national competent authorities of the European member states and the European Medicines Agency, in this case, the Committee on Herbal Medicinal Products, reacted to these findings by setting limits for all herbal medicinal products. This review article will briefly discuss the data leading to the establishment of thresholds and the regulatory developments and consequences, as well as the current discussions and research in this area.

scholarly journals A RIPPLE EFFECT OF COVID-19 PANDEMIC ON SHORTAGE OF MEDICINAL PRODUCTS AND ITS IMPACT ON PATIENT CARE

2021 ◽  
pp. 364-370
Author(s):  
BIPLAB KUMAR DEY ◽  
EFFICIENCY MYRSING ◽  
RUHUL AMIN ◽  
FARUK ALAM ◽  
MIZANUR RAHMAN ◽  
...  
Keyword(s):  
Health Care ◽  
Medicinal Product ◽  
Antimicrobial Agents ◽  
The United States ◽  
Public Health Issue ◽  
European Medicines Agency ◽  
Ripple Effect ◽  
Medicinal Products ◽  
Short Supply ◽  
The Impact

Objective: Shortages of medicinal products are complex global problems. Drug shortages remain a significant public health issue. Global shortages of medical products have a potential effect on patient health and total healthcare costs. Countries worldwide, especially those affected by Coronavirus disease 2019 (COVID-19), is experiencing a rapid increase in drug shortage, which causes several complications for physicians, health care provider, patients, health institutes and health regulatory bodies. Methods: To carry out the study of shortages, several efforts have been taken by the regulators and industries. Prominent amongst these include FDA's research the needs and the reforms made in the regulations about shortages. We also searched for electronic databases (PubMed, Science direct, Web of Science) using the terms (COVID-19 and shortage) or (medicine and COVID-19) for articles in periods of 2019 to 2021. Results: On assessment based on the report, the number of shortage drugs in 2020 is 835; Anesthesia drugs are highest during the COVID-19 outbreak data indicate the number of shortages is 143 in USA. It was found that generic products were mostly in short supply, with antimicrobial agents (63%) topping the list of therapeutic categories of medicines with interrupted supply, followed by oncology medicines (47%) and then anesthetic agents (38%) during COVID-19 pandemic. Conclusion: Many steps have been taken to reduce the impact of a shortage of health care. Agencies like the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) has established guidelines and works with manufacturers and other partners to help prevent shortages. This article aims to the analysis the root cause of medicinal product shortages, their effects on the patient outcome, medication error, which occurs due to the substitution safe and effective therapies with alternative treatments, identify possible solutions and policies established to manage medicinal product shortages.

Patient Selection for in Vitro Fertilization: Physical and Psychological Aspects

1985 ◽  
Vol 442 (1 In Vitro Fert) ◽  
pp. 490-503 ◽  
Author(s):  
W. I. H. JOHNSTON ◽  
K. OKE ◽  
A. SPEIRS ◽  
G. A. CLARKE ◽  
J. McBAIN ◽  
...  
Keyword(s):  
In Vitro Fertilization ◽  
Patient Selection ◽  
Psychological Aspects ◽  
Vitro Fertilization ◽  
Selection For

Improvement of effectiveness in maize breeding

2006 ◽  
Vol 54 (3) ◽  
pp. 351-358 ◽  
Author(s):  
P. Pepó
Keyword(s):  
Recurrent Selection ◽  
Genetic Manipulation ◽  
Field Testing ◽  
Tissue Cultures ◽  
Maize Breeding ◽  
Breeding Programmes ◽  
Speed Up ◽  
Selection For

Plant regeneration via tissue culture is becoming increasingly more common in monocots such as maize (Zea mays L.). Pollen (gametophytic) selection for resistance to aflatoxin in maize can greatly facilitate recurrent selection and the screening of germplasm for resistance at much less cost and in a shorter time than field testing. In vivo and in vitro techniques have been integrated in maize breeding programmes to obtain desirable agronomic attributes, enhance the genes responsible for them and speed up the breeding process. The efficiency of anther and tissue cultures in maize and wheat has reached the stage where they can be used in breeding programmes to some extent and many new cultivars produced by genetic manipulation have now reached the market.

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