Abstract:
:Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in September 2018. The Drug Technical Advisory Board (DTAB) recommended that 'there is no therapeutic justification' for the active ingredients in the banned FDCs and accordingly these combinations 'may involve a risk to human beings'. Areas covered: The review illustrates the present status of FDCs, its regulatory framework, approvals in India and discusses the substantive cause behind the ban on FDCs in India. Expert opinion: The expert stress to establish a robust regulatory system for the approval of FDCs in India. The pharmaceutical industries should not perceive the ban against irrational FDCs as an impediment; rather, they should view as an opportunity to establish a stronger healthcare system. The current review is an eye-opener for the section of people who consider that the ban on FDCs is irrational. However, the ban on 328 FDCs may prove a landmark decision for the development of stronger healthcare policy in India.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Miranda MRH,Dubey A,G S R,Charyulu RNdoi
10.1080/14740338.2019.1651292subject
Has Abstractpub_date
2019-10-01 00:00:00pages
977-985issue
10eissn
1474-0338issn
1744-764Xjournal_volume
18pub_type
杂志文章,评审abstract:INTRODUCTION:In the past two decades, the number of women with autoimmune and inflammatory diseases experiencing a pregnancy has significantly increased in parallel with the enormous advances in the diagnosis and management of these disorders. However, information regarding the safety of immunosuppressive agents comes ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.951326
更新日期:2014-12-01 00:00:00
abstract::Psychosis in Alzheimer's disease is common and troublesome. The impact on the quality of life of both patients and caregivers is high and drug treatments raise concern in terms of both efficacy and safety. Therefore, identifying the risk factors that play an important role in the onset of psychosis is mandatory for th...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
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abstract:INTRODUCTION:The antimalarial drug hydroxychloroquine (HCQ) is widely used to treat various rheumatic diseases. Many autoimmune diseases occur in women of child-bearing age who may become pregnant while on therapy, which raises concerns regarding the teratogenicity of HCQ and its effect on the outcome of the pregnancy....
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
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abstract::It is estimated that over three-quarters of a million people are injured or die in hospitals each year from adverse drug events (ADEs). The majority of medical errors result from poorly designed healthcare systems rather than from negligence on the part of healthcare providers. In general, healthcare systems rely on v...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.3.5.449
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abstract:INTRODUCTION:Nephrotoxicity is generally considered as the most clinically significant adverse reaction of amphotericin B, and has been reported in up to 80% of amphotericin B recipients during the first 2 weeks of treatment. Numerous experimental and clinical investigations have been performed over the past 4 decades,...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.721775
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abstract::Introduction: Botulinum toxin (BoNT) is a protein secreted by the anaerobic Gram-negative bacterium Clostridium botulinum. Among the seven known subtypes, type A is the most commonly used in women to treat diseases. It primarily blocks presynaptic release of acetylcholine at the neuromuscular junction, resulting in te...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2020.1707803
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abstract:INTRODUCTION:Neuroendocrine neoplasms (NEN) represent a heterogeneous group of malignancies generally characterized by low proliferation and indolent course. However, about half of the newly diagnosed cases are metastatic and require long-term systemic therapies. Areas covered: This review revises the literature to sum...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1354984
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abstract::In October of 2003, the FDA issued a public health warning stating that preliminary evidence showed selective serotonin re-uptake inhibitors (SSRIs) and related antidepressants might be associated with excess reports of suicidality. In 2004, the FDA convened a committee of neuropsychiatric and pediatric subcommittee m...
journal_title:Expert opinion on drug safety
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journal_title:Expert opinion on drug safety
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abstract:INTRODUCTION:Over the past decade, increased prescription supply has facilitated an epidemic of nonmedical use of controlled substances, including predominantly opioids, as well as benzodiazepines, z-hypnotics, and stimulants. Areas covered: More recently, misuse of noncontrolled prescriptions, such as gabapentin, has ...
journal_title:Expert opinion on drug safety
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
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abstract:INTRODUCTION:In settings where HIV is prevalent in heterosexual populations, pregnancy and postpartum breastfeeding periods can be associated with substantial HIV acquisition risk. Pre-exposure prophylaxis (PrEP) with daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine is an attractive HIV prevention option fo...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1338271
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abstract:INTRODUCTION:Cardiovascular disease remains the major contributor to morbidity and mortality in diabetes. From the need to reduce cardiovascular risk in diabetes and to ensure that such risk is not exacerbated by drug treatments, governmental regulators and drug manufacturers have focused on clinical trials evaluating ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1195368
更新日期:2016-09-01 00:00:00
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.6.835
更新日期:2006-11-01 00:00:00
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2017.1273346
更新日期:2017-02-01 00:00:00
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1346083
更新日期:2017-09-01 00:00:00
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.7.4.351
更新日期:2008-07-01 00:00:00
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740330903413514
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
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journal_title:Expert opinion on drug safety
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journal_title:Expert opinion on drug safety
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journal_title:Expert opinion on drug safety
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
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journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
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