scholarly journals Biomedical Consideration in the Manufacture, Clinical Trial and Bioequivalence Studies of Pharmaceuticals

1970 ◽  
Vol 2 (1) ◽  
pp. 18-21 ◽  
Author(s):  
ABM Faroque
Keyword(s):  
Clinical Trial ◽  
Human Subjects ◽  
Bioequivalence Study ◽  
Pharmaceutical Sector ◽  
Counterfeit Drugs ◽  
New Era ◽  
National Market ◽  
Trade Name ◽  
Study Results ◽  
Pharmaceutical Industries

Bangladesh pharmaceutical sector has been growing at a remarkable speed since 1982. From the meager 30% national market share, now it is supplying 97% of our annual demand. Around 1,100 generics are now available in a total of around 12,000 trade name products. The national market size has crossed 6,000 crore taka per annum, where the local multinational share is only 7%. Our industries are now exporting drugs to 72 countries. But just because our pharmaceutical sector has developed its own backbone does not meant that our pharmaceutical industries have solved the relevant bioethical questions. There are complaints that some companies do not pursue necessary bioethical norm as at various levels of its manufacturing processes. Still a good number of small companies sell sub-standard and counterfeit drugs, and yet some are not following accepted GMP standards. Moreover, for capturing foreign markets we need clinical trials and bioequivalence study results. These study needs human subjects as volunteers. In a poverty-stricken country like us, if we do not establish these clinical trial and bioequivalence norms, everything becomes irrelevant. If we can establish theses norms, this could be the beginning of a new era for further growth of our pharmaceutical industries vis-à-vis our public health national economy.DOI: http://dx.doi.org/10.3329/bioethics.v2i1.9813  Bangladesh Journal of Bioethics 2011; 2(1): 18-21

scholarly journals Commitments by the biopharmaceutical industry to clinical trial transparency: the evolving environment

2019 ◽  
Vol 24 (5) ◽  
pp. 177-184 ◽  
Author(s):  
Slavka Baronikova ◽  
Jim Purvis ◽  
Eric Southam ◽  
Julie Beeso ◽  
Antonia Panayi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pharmaceutical Research ◽  
Trial Data ◽  
European Federation ◽  
Biopharmaceutical Industry ◽  
Legal Requirements ◽  
Study Results ◽  
Pharmaceutical Industries ◽  
The Mean ◽  
Disclosure Rate

Clinical trial sponsors have ethical obligations to register protocols, report study results and comply with applicable legal requirements. To evaluate public commitments to trial disclosure and rates of disclosure by members and non-members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and/or the Pharmaceutical Research and Manufacturers of America (PhRMA). Websites of the top 50 biopharmaceutical companies by 2015 sales were searched for statements relating to trial data disclosure. Disclosure of trial results completed by biopharmaceutical industry and non-industry sponsors of at least 30 trials (2006–2015) was assessed using TrialsTracker. Among the top 50 companies, 30 were EFPIA/PhRMA members and 20 were non-members, of which 26 and none, respectively, had a statement on their website committing to the disclosure of trials data. Of 29 377 trials in TrialsTracker, 9511 were industry sponsored (69 companies) and 19 866 were non-industry sponsored (254 institutions). The overall mean disclosure rate was 55%, with higher rates for industry (74%) than for non-industry sponsors (46%). Of the 30 companies within the top 50 with data in TrialsTracker, the mean disclosure rate was 76% (77% for EFPIA/PhRMA members [n=25] vs 67% for non-members [n=5]). Most of the top 50 biopharmaceutical companies have publicly committed to the disclosure of trial data. Industry sponsors have responded to the ethical and legal demands of trial disclosure by disclosing three quarters of their trials compared with less than half for non-industry sponsors. Further improvements in clinical trial disclosure are needed.

Delay Discounting in Impulsive Behavior

2019 ◽  
Vol 24 (4) ◽  
pp. 312-321 ◽  
Author(s):  
Diana Moreira ◽  
Fernando Barbosa
Keyword(s):  
Delay Discounting ◽  
Human Subjects ◽  
Empirical Studies ◽  
Cochrane Collaboration ◽  
Initial Assessment ◽  
Impulsive Behavior ◽  
Manual Search ◽  
Study Results ◽  
Depth Analysis ◽  
The Future

Abstract. Delay discounting (DD) is the process of devaluing results that happen in the future. With this review, we intend to identify specificities in the processes of DD in impulsive behavior. Studies were retrieved from multiple literature databases, through rigorous criteria (we included systematic reviews and empirical studies with adult human subjects), following the procedures of the Cochrane Collaboration initiative. Of the 174 documents obtained, 19 were considered eligible for inclusion and were retained for in-depth analysis. In addition, 13 studies from the manual search were included. Thus, a total of 32 studies were selected for review. The objectives/hypotheses, results, and the main conclusion(s) were extracted from each study. Results show that people with pronounced traits of impulsivity discount rewards more markedly, that is, they prefer immediate rewards, though of less value, or postponed losses, even though they worsen in the future. Taken together, the existing data suggest the importance of inserting DD as a tool for initial assessment in conjunction with measures of addiction and stress level, as well as the consideration of new therapies.

scholarly journals Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041458
Author(s):  
Vicki Anderson ◽  
Vanessa C Rausa ◽  
Nicholas Anderson ◽  
Georgia Parkin ◽  
Cathriona Clarke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Normal Activity ◽  
Secondary Outcome ◽  
Open Label ◽  
Human Research Ethics ◽  
Postconcussive Symptoms ◽  
Study Results ◽  
Registration Number ◽  
Initial Injury

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.

Neither Global Nor Standard: Corporate Strategies in the New Era of Labor Standards

10.1068/a3789 ◽  
2005 ◽  
Vol 37 (11) ◽  
pp. 1919-1938 ◽  
Author(s):  
Susan Christopherson ◽  
Nathan Lillie
Keyword(s):  
Country Of Origin ◽  
Transnational Corporation ◽  
Marketing Strategies ◽  
Labor Standards ◽  
New Era ◽  
Political Processes ◽  
Corporate Strategies ◽  
Labor Practices ◽  
National Market ◽  
Market Governance

Two multinational retail firms, IKEA and Wal-Mart, illuminate the implications of a new era of labor standards—focused on the transnational firm. Global labor standards are increasingly enforced through transnational corporation (TNC) adherence to voluntary codes rather than through national labor regulation. Nonetheless, privatized labor-standards regimes within TNCs continue to be influenced by the national market governance framework in the TNC country of origin. Although, in principle, labor standards are arrived at through global political processes, in practice they are applied in conjunction with TNC production and marketing strategies. The way in which corporate objectives intersect with labor practices is different from one TNC to another, depending in large part on political and regulatory influences in the country of origin of a particular TNC.

Simultaneous determination of duloxetine and 4-hydroxy duloxetine glucuronide in human plasma and back-conversion study

Bioanalysis ◽  
2021 ◽  
Author(s):  
Gabriel Onn Kit Loh ◽  
Emily Yii Ling Wong ◽  
Yvonne Tze Fung Tan ◽  
Yi Lin Lee ◽  
Chun Keat Chew ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Human Plasma ◽  
Method Validation ◽  
Bioequivalence Study ◽  
Stability Study ◽  
Bioanalytical Method Validation ◽  
Study Materials ◽  
Study Results ◽  
Back Conversion

Aim: To develop an LC-MS/MS method for simultaneous determination of duloxetine and its metabolite, 4-hydroxy duloxetine glucuronide (4HDG) in human plasma and to investigate the potential back-conversion of 4HDG to duloxetine using stability study. Materials & methods: The LC-MS/MS method was validated according to the EMA and USFDA Bioanalytical Method Validation Guidelines and applied to pilot bioequivalence study. Results & conclusion: The method validation results were within the acceptance limits. The stability study and incurred sample reanalysis results ruled out the occurrence of back-conversion. The study highlighted the conduct of back-conversion test and the advantages of LC-MS/MS method in terms of sensitivity, specificity and low consumption of organic solvents.

Dissociative Anesthetics: Angel Dust to Special K to Ketamine Clinics

2020 ◽  
Author(s):  
Jerrold Winter
Keyword(s):  
Cardiac Rhythm ◽  
Drugs Of Abuse ◽  
Breast Biopsy ◽  
Human Subjects ◽  
Anesthetic Agents ◽  
Dilation And Curettage ◽  
Trade Name ◽  
Dissociative Anesthetics

We will consider just two drugs in this chapter. They are phencyclidine and ketamine. Both are widely used as anesthetic agents, ketamine in humans and phencyclidine in animals. The acronym for phencyclidine that we will use, PCP, comes from its chemical name 1-(1-PhenylCyclohexyl)-Piperidine. In addition to their medical use, both ketamine and PCP have gained roles as recreational drugs or, as others would put it, drugs of abuse. While sharing some of the properties of the depressant drugs we met in the preceding chapter, PCP and ketamine are pharmacologically and ther­apeutically unique. On March 26, 1956, V. Harold Maddox, a chemist working at the research laboratories of Parke, Davis & Company in Detroit, synthesized a novel compound later to be called phencyclidine. PCP was submitted in the autumn of that year for testing in animals. Pigeons, mice, rats, Guinea pigs, rabbits, dogs, cats, and monkeys all had their turn. Depending on the dose employed and the species in which it was tested, the effects ranged from excitement and stimulation to taming and quieting. Analgesia, that is, absence of pain without loss of consciousness, and anesthesia were common but, unlike the depressant drugs we met in the previous chapter, the anesthesia was not accompanied by depression of breathing. Studies in human subjects began in May 1957 at the Department of Anesthesiology of the Detroit Receiving Hospital. By this time, PCP had been given the trade name Sernyl. The drug initially was administered to seven volunteers. As had previously been noted in animals, there was no suppression of breathing or disturbance of cardiac rhythm, highly desirable qualities in an anesthetic agent. The investigators then moved on to 64 patients ranging in age from 18 to 78, 47 of whom were women, who were to undergo various surgical procedures, including breast biopsy, dilation and curettage, skin grafts, hysterectomy, and hernia repair. Immediately after the intravenous administration of PCP, there was what the anesthesiologists called “a profound state of analgesia” permitting surgical incision and, in many cases, completion of the operation without the use of other drugs.

scholarly journals Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035768
Author(s):  
Josefa Gonzalez-Santos ◽  
Raul Soto-Camara ◽  
Paula Rodriguez-Fernández ◽  
Maria Jimenez-Barrios ◽  
Jeronimo Gonzalez-Bernal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Upper Extremity ◽  
Randomised Clinical Trial ◽  
Therapeutic Exercise ◽  
Mirror Therapy ◽  
Link Type ◽  
Home Based ◽  
Study Results ◽  
Task Oriented

IntroductionNeuroplasticity is defined as the capacity of the brain to reorganise new neuronal pathways. Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke. Home-based interventions are an appropriate alternative to promote independence and autonomy. The objective of this study is to evaluate which of these techniques, MT and CTE, combined with task-oriented training, is more effective in functional recovery and movement patterns of the upper extremities in patients with severe hemiparesis after a stroke.Methods and analysisThis is a home-based, single-blind, controlled, randomised clinical trial with three parallel arms, including 154 patients who had a stroke aged above 18 years. The primary outcome will be the functionality of the affected upper extremity measured using the Fugl-Meyer Assessment. Secondary variables will include cognitive performance, emotional state, quality of life and activities of daily living. During 6 weeks, one of the intervention groups will receive a treatment based on MT and the other one on CTE, both combined with task-oriented training. No additional interventions will be provided to the control group. To assess the progress of patients who had a stroke in the subacute phase, all variables will be evaluated at different visits: initial (just before starting treatment and 4 weeks post-stroke), post-intervention (6 weeks after initial) and follow-up (6 months).Ethics and disseminationThis protocol has been approved by the Institutional Review Board (CEIm-2.134/2.019) and registered at ClinicalTrials.gov (NCT04163666). The results will be disseminated through open-access peer-reviewed journals, conference presentation, broadcast media and a presentation to stakeholders. These study results will provide relevant and novel information on effective neurorehabilitation strategies and improve the quality of intervention programmes aimed at patients after a stroke.Trial registration numberClinicalTrials.gov (NCT04163666).

scholarly journals Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e038300
Author(s):  
Nick Daneman ◽  
Asgar H Rishu ◽  
Ruxandra L Pinto ◽  
Yaseen M Arabi ◽  
Deborah J Cook ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Antibiotic Treatment ◽  
Treatment Duration ◽  
Bloodstream Infections ◽  
Clinical Effectiveness ◽  
Randomised Clinical Trial ◽  
Prosthetic Material ◽  
Link Type ◽  
Study Results ◽  
Registration Number

IntroductionBloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied.Methods and analysisWe will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors (Staphylococcus aureus, Staphylococcus lugdunensis, Candida and contaminant organisms). We will leave the selection of specific antibiotics, doses and route of delivery to the discretion of treating physicians; no placebo control will be used given the diversity of pathogens and sources of bacteraemia. The intervention will be assignment of treatment duration to be 7 versus 14 days. We will minimise selection bias via central randomisation with variable block sizes, with concealed allocation until day 7 of adequate antibiotic treatment. The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality. Secondary outcomes include hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days, Clostridium difficile infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms.Ethics and disseminationThe study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study results via the Canadian Critical Care Trials Group and other collaborating networks to set the global paradigm for antibiotic treatment duration for non-staphylococcal Gram-positive, Gram-negative and anaerobic bacteraemia, among patients admitted to hospital.Trial registration numberThe BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).

scholarly journals Returning aggregate results of clinical trials: Empirical data of patient preferences

2018 ◽  
Vol 2 (6) ◽  
pp. 356-362 ◽  
Author(s):  
Carmen E. Aldinger ◽  
Jennifer Ligibel ◽  
Im Hee Shin ◽  
John W. Denninger ◽  
Barbara E. Bierer
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Integrative Medicine ◽  
Patient Preferences ◽  
Empirical Data ◽  
Online Survey ◽  
Plain Language ◽  
Research Participants ◽  
Study Results

AbstractIntroduction:The purpose of this research was to understand the preferences of patients receiving integrative medicine services for return of aggregate study results.Methods:A brief online survey (survey 1) was sent to 341 cancer patients receiving integrative medicine interventions; subsequently, a minimally revised survey (survey 2) was sent to 812 individuals with various medical conditions who had been either research participants in integrative medicine studies (n = 446) or patients (n = 346) of mind–body medicine.Results:Feedback to a model plain language summary was elicited from survey 1 and survey 2 respondents. Seventy-seven survey recipients (23%) responded to survey 1, and 134 survey recipients (17%) responded to survey 2. The majority of respondents to the surveys were female and 51–70 years of age. Ninety percent of responders to survey 1 and 89% of responders to survey 2 indicated that researchers should share overall results of a study with participants. In terms of the means of result distribution, 37%–47% preferred email, while 22%–27% indicated that, as long as the results are shared, it did not matter how this occurred. Of 38 survey 1 respondents who had previously participated in a clinical trial, 37% had received the results of their study. In survey 2, 63 individuals indicated that they previously participated in clinical trials, but only 16% recalled receiving results.Conclusions:These results confirm that the majority (89%–90%) of integrative medicine patients are interested in receiving the results of clinical trials. The majority (82%–94%) of respondents felt the model plain language summary of results provided was helpful.

scholarly journals Efficacy Study of Folic Acid Supplementation on Homocysteine Levels in Adolescent Epileptics Taking Antiepileptic Drugs: A Single Blind Randomized Controlled Clinical Trial

2019 ◽  
Vol 26 (3-4) ◽  
pp. 50-54
Author(s):  
Uma A. Bhosale ◽  
Radha Yegnanarayan ◽  
Akhil Agrawal ◽  
Ashwini Patil
Keyword(s):  
Risk Factors ◽  
Clinical Trial ◽  
Folic Acid ◽  
Antiepileptic Drugs ◽  
Chronic Medical Condition ◽  
Cvd Risk Factors ◽  
Cvd Risk ◽  
Study Results ◽  
Epileptic Patients

Background: Epilepsy is a chronic medical condition that requires long-term therapy with antiepileptic drugs (AEDs). However, long-term employment of AEDs may lead to the onset of hyperhomocysteinemia, which has been found to modulate imperative metabolic mechanisms and induce cardiovascular disorders (CVDs). Therefore, adolescent population that have been diagnosed with epilepsy and utilize AEDs are among the most vulnerable, exhibiting higher risks of developing CVDs. Purpose: The present study was designed to explore the effects of folic acid (FA) supplementation on AED-induced hyperhomocysteinemia and CVD risk factors in adolescent epileptics. Methods: The randomized clinical trial included adolescent epileptics (i.e., 10–19 years of age) of either sex, on antiepileptic therapy for > 6 months with high homocysteine levels (i.e., >10.9 µmol/L). At the time of enrolment, their baseline BP, lipid and homocysteine levels were recorded. Participants were randomly assigned to either treatment or placebo groups and received the respective treatments. At the end of the first month, BP, lipid and homocysteine levels were recorded and compared to determine the effect of FA on these parameters. Results and conclusion: A significant fall in homocysteine levels was observed with FA supplementation ( P < 0.05). However, this fall was significantly high in valproic acid treated epileptic patients. In addition, we observed an improvement in high-density lipoprotein levels, a risk factor for CVDs, but the change was statistically insignificant ( P > 0.05). The study results suggest that FA supplementation in epileptic patients receiving AED therapy may minimize AED-induced hyperhomocysteinemia and other CVD risk factors.

Sign in / Sign up

Export Citation Format

Share Document