The Dosage Form: US and EC Requirements for Documenting the Method of Preparation and Control of Clinical Trials' Supplies and the Final Dosage Form Proposed for Marketing

1989 ◽  
Vol 23 (3) ◽  
pp. 429-438
Author(s):  
Klaus Salm ◽  
Arnold Urdang
Keyword(s):  
Clinical Trials ◽  
Dosage Form ◽  
And Control ◽  
Final Dosage Form

scholarly journals National control laboratory independent lot testing of COVID-19 vaccines: the UK experience

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Nicola J. Rose ◽  
Paul Stickings ◽  
Silke Schepelmann ◽  
Marc J. A. Bailey ◽  
Chris Burns
Keyword(s):  
Clinical Trials ◽  
Vaccine Development ◽  
Regulatory Approval ◽  
Safety Measures ◽  
Discovery Research ◽  
Innovative Products ◽  
The Uk ◽  
Vaccine Availability ◽  
And Control

AbstractThe past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availability in the pandemic has meant that new approaches to development, manufacturing, and regulation have been required: this has necessitated many stages of product development, clinical trials, and manufacturing to be undertaken in parallel at a global level. Through the development of these innovative products, the world has the best chance of finding individual, or combinations of, vaccines that will provide adequate protection for the world’s population. Despite the huge scientific and regulatory achievements and significant investment to accelerate vaccine availability, it is essential that safety measures are not compromised. Here we focus on the post regulatory approval testing by independent laboratories that provides an additional assurance of the safety and quality of a product, with an emphasis on the UK experience through the National Institute for Biological Standards and Control (NIBSC), an expert centre of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

scholarly journals SARS-CoV-2 / COVID-19: Salient Facts and Strategies to Combat Ongoing Pandemic

2020 ◽  
Vol 14 (3) ◽  
pp. 1663-1674
Author(s):  
Ranjit Sah ◽  
Nayanum Pokhrel ◽  
Zareena Fathah ◽  
Akihiko Ozaki ◽  
Divya Bhandari ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Prevention And Control ◽  
One Health ◽  
Close Contact ◽  
Mitigation Strategies ◽  
Virus Spread ◽  
Intermediate Hosts ◽  
Affected Person ◽  
Novel Coronavirus ◽  
And Control

Severe acute respiratory syndrome coronavirus – 2 (SARS-CoV-2), an emerging novel coronavirus causing coronavirus disease 2019 (COVID-19) pandemic, has now rapidly spread to more than 215 countries and has killed nearly 0.75 million people out of more than 20 million confirmed cases as of 10th August, 2020. Apart from affecting respiratory system, the virus has shown multiple manifestations with neurological affections and damaging kidneys. SARS-CoV-2 transmission mainly occurs through close contact of COVID-19 affected person, however air-borne route is also now considered as dominant route of virus spread. The virus has been implicated to have originated from animals. Apart from bats, pangolins and others being investigates to play role in transmitting SARS-CoV-2 as intermediate hosts, the recent reports of this virus infection in other animals (cats, dogs, tigers, lions, mink) suggest one health approach implementation along with adopting appropriate mitigation strategies. Researchers are pacing to develop effective vaccines and drugs, few reached to clinical trials also, however these may take time to reach the mass population, and so till then adopting appropriate prevention and control is the best option to avoid SARS-CoV-2 infection. This article presents an overview on this pandemic virus and the disease it causes, with few recent concepts and advances.

Trends in case-control allocation in phase III randomized cancer clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14582-e14582
Author(s):  
Shruti Gupta ◽  
Swathi Gopishetty ◽  
Srishti Malhotra ◽  
Vamsi Kota ◽  
Anand P. Jillella ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Trial Design ◽  
Phase Iii ◽  
Cancer Clinical Trials ◽  
Unequal Distribution ◽  
Equal Distribution ◽  
Advantages And Disadvantages ◽  
Significant Difference ◽  
And Control ◽  
Unequal Allocation

e14582 Background: Patients enrollment in cancer clinical trials has traditionally been limited to an equal distribution between cases and controls. Some clinical trials have an unequal distribution between the case and control arm. Although such unequal allocation is uncommon it has certain advantages and disadvantages to it. The trend and proportion of cancer clinical trials that have an unequal allocation has not been studied. Methods: Data about cancer clinical trials was extracted from clinical trials.gov. The query included phase 3 trials which included adults and were conducted between 2010 to 2017. Only clinical trials that were either completed or active – but not recruiting were included. T test was used to determine statistical difference between different subgroups. Results: 601 clinical trials were identified of which 356 trials with two arms and 47 trials with 3+ arms were identified. Amongst the eligible 298 trials with two arms, there were 216 trials with equal allocation (1:1) and 82 trials with unequal allocation. Amongst the eligible 29 trials with 3+ arms; there were 21 trials with equal allocation (1:1:1) and 8 trials with unequal allocation. There was no significant difference in the proportion of trials with unequal allocation over the time period from 2010 to 2017. The categories of cancer which had the highest number of two arm clinical trials with unequal allotment were: genitourinary, breast and hematological malignancies (Table). Conclusions: Cancer clinical trials with unequal allocation between case and control arms have been common in the past decade. This may represent a new trend in clinical trial design to help enhance closer monitoring of adverse events despite higher costs attached to this method.[Table: see text]

Benzyldimethyl[3-(miristoylamino)-propyl]ammonium chloride stabilized silver nanoparticles (Argumistin™) in medicine: results of clinical trials for treatment of infectious diseases of dogs and perspectives for humans

2016 ◽  
Vol 8 (4) ◽  
Author(s):  
Yurii Krutyakov ◽  
Alexey Klimov ◽  
Boris Violin ◽  
Vladimir Kuzmin ◽  
Victoria Ryzhikh ◽  
...  
Keyword(s):  
Silver Nanoparticles ◽  
Clinical Trials ◽  
Infectious Diseases ◽  
Ammonium Chloride ◽  
Dosage Form ◽  
Multiple Drug Resistance ◽  
Periodontal Diseases ◽  
Veterinary Drug ◽  
Antibacterial Drug ◽  
Eye Drops

AbstractIncreased interest in nanosilver during the last 10 years is mainly explained by the emergence and spread of pathogenic microorganisms with multiple drug resistance, including resistance to last-generation antibiotics. In this article, we for the first time, give a description of large-scale clinical trials of a new nanosilver based antibacterial drug [containing two active components: silver nanoparticles (AgNPs) (10–50 ppm) and benzyldimethyl[3-(miristoylamino)-propyl]ammonium chloride (100 ppm)] registered in Russia in 2015 as a veterinary drug under the brand name Argumistin™. This drug has been approved for application in a diluted dosage form – as eye drops, intranasal drops and orally; it has also been approved for application in a more concentrated dosage form (up to 50 ppm of nanosilver) as ear drops and as an antiseptic during demodicosis and gum disease treatment, open wound treatment, etc. We have registered the high therapeutic effectiveness of Argumistin™ during treatment of infectious conjunctivitis, gingivitis, parodontosis and enteritis of dogs. Application of this antibacterial drug gives considerable (up to 70% in case of periodontal diseases) reduction in the treatment period and prevention of complications. The results of clinical trials in the treatment of infectious diseases of dogs makes Argumistin™ a promising candidate for an effective antibacterial drug for human medicine.

scholarly journals Sediaan Ekstrak Air Daun Gaharu (Aquilaria microcarpa) Memiliki Potensi Memperbaiki Kulit yang Terpapar Sinar Ultraviolet

2020 ◽  
Vol 7 (1) ◽  
pp. 36
Author(s):  
Destria Indah Sari ◽  
Dina Rahmawanty ◽  
Yunita Jultan ◽  
Siti Sumiati Naba
Keyword(s):  
Vitamin D ◽  
Free Radicals ◽  
Dosage Form ◽  
Ultraviolet Rays ◽  
Control Group ◽  
Skin Disorders ◽  
Cell Numbers ◽  
Negative Effect ◽  
And Control

ABSTRAK Sinar ultraviolet dapat memberikan dampak yang merugikan terhadap kulit. Meskipun sinar ultraviolet juga memberikan manfaat seperti memediasi sintesis vitamin D, namun paparan berlebih sinar ultraviolet dapat menyebabkan kelainan kulit dan dapat menimbulkan resiko kesehatan, seperti atropi, perubahan pigmen, keriput, dan malignancy (keganasan). Reaksi tersebut timbul karena pembentukan radikal bebas dan untuk mengatasinya diperlukan antioksidan. Ekstrak daun Aquilaria microcarpa diketahui mengandung flavanoid, yang dapat berfungsi sebagai antioksidan. Pemanfaatan ekstrak daun Aquilaria microcarpa dalam bentuk sediaan merupakan langkah untuk meningkatkan kenyamanan pemakaian dan memaksimalkan manfaat ekstrak. Penelitian ini bertujuan untuk menentukan kemampuan sediaan ekstrak daun Aquilaria microcarpa dalam memperbaiki kulit yang terpapar sinar matahari. Kulit yang digunakan dalam penelitian adalah kulit mencit dewasa galur Balb/C yang telah diberi perlakuan selama 8 hari.  Pengamatan dilakukan terhadap lapisan epidermis dan dermis terhadap masing-masing ketebalan dan jumlah melanosit. Hasil penelitian menunjukkan sediaan ekstrak daun Aquilaria microcarpa memiliki potensi memperbaiki kulit yang terpapar sinar ultraviolet. Kata Kunci: paparan sinar ultraviolet, Aquilaria microcarpa,   ABSTRACT Ultraviolet rays could give negative effect to skin. Although ultraviolet rays also give benefit, for example, catalyzing vitamin D synthesis, but excessive exposure of ultraviolet rays may cause skin disorders, such as atropy, pigment changes, wrinkles, and malignancy. Those reactions caused by free radicals formation and need antioxidant to reduce them. Aquilaria microcarpa leaves extract were revealed to have flavanoid, which can be used as antioxidant. Its usage as dosage form was a step to increase acceptability and to maximize benefit of the extract. This research was aimed to determined Aquilaria microcarpa leaves extract ability to recover skin-previously exposed to ultraviolet rays. Skin used in this research were full grown mice Balb/C whom treated after 8 days. Epidermis thickness and melanocyte cell numbers were counted and compared with UV group and control group. The result showed Aquilaria microcarpa leaves extract as dosage form has potency to recover skin which exposure to ultraviolet rays. Keywords: ultraviolet rays exposure, Aquilaria microcarpa

scholarly journals Effect of Coffee, Tobacco, and Alcohol on Parkinson’s Disease

2021 ◽  
Vol 39 (3) ◽  
pp. 129-133
Author(s):  
Wongi Seol ◽  
Hyejung Kim ◽  
Ilhong Son
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Clinical Studies ◽  
Control Groups ◽  
Neuroprotective Effects ◽  
Effective Components ◽  
And Control

Since the neuroprotective effects of coffee and tobacco on Parkinson’s disease have been reported more than 50 years ago, clinical studies using caffeine and nicotine that were presumed as effective components of coffee and tobacco, respectively, are being actively executed. However, most results failed to show significant differences between the tested and control groups, and some studies revealed contradictory results to the neuroprotection. The reason for this might be that the effective components are something other than nicotine or caffeine, and/or differences to design the clinical trials such as patients recruiting, prescribed amount and period, and analyzed criteria etc. The review summarizes recent results for effect of coffee, tobacco as well as alcohol, representatives of indulgent food, on Parkinson’s disease.

scholarly journals Safety and Immunogenicity of Sabin Strain Inactivated Poliovirus Vaccine Compared With Salk Strain Inactivated Poliovirus Vaccine, in Different Sequential Schedules With Bivalent Oral Poliovirus Vaccine: Randomized Controlled Noninferiority Clinical Trials in China

2019 ◽  
Vol 6 (10) ◽  
Author(s):  
Yuemei Hu ◽  
Kangwei Xu ◽  
Weixiao Han ◽  
Kai Chu ◽  
Deyu Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Wild Strain ◽  
Oral Polio Vaccine ◽  
Control Groups ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Type 3 ◽  
And Control

Abstract Background A new Sabin strain inactivated poliovirus vaccine (sIPV) proved to be immunogenic and safe in all IPV primary immunization in the previous study, with the corresponding profiles in sequential immunizations unclear. Methods Two clinical trials on the “IPV + 2 bivalent oral polio vaccine (2bOPV)” (Trial A) and “2IPV + bOPV” (Trial B) vaccination were conducted. Both clinical trials were randomized, controlled, double-blinded, noninferiority trials, and wild-strain IPV (wIPV) was adopted as the control vaccine. In each clinical trial, 240 healthy infants were enrolled and randomly assigned to receive sequential vaccinations containing sIPV or wIPV. Immunogenicity and safety were assessed using per-protocol and safety populations, respectively. Results For Trial A, the seroconversion rates in the experimental and control groups were 100% and 99.1%, respectively, against type 1; both 100.0% against type 3. For Trial B, the seroconversion rates in experimental and control groups were 99.2% and 100.0%, respectively, against type 1; both 100% against type 3. No serious adverse events related to vaccines were reported. Conclusions The new sIPV demonstrated an immunogenicity noninferior to that of the wIPV and a good safety profile in sequential vaccination with bOPV. Clinical trial numbers NCT:03822754; NCT:03822767.

Drug Nanocrystals: A Comprehensive Review with Current Regulatory Guidelines

2020 ◽  
Vol 17 (6) ◽  
pp. 470-482
Author(s):  
Mori Dhaval ◽  
Jalpa Makwana ◽  
Ekta Sakariya ◽  
Kiran Dudhat
Keyword(s):  
Dissolution Rate ◽  
Dosage Form ◽  
Poorly Soluble Drugs ◽  
Comprehensive Review ◽  
Drug Molecules ◽  
Regulatory Guidelines ◽  
Poorly Soluble ◽  
Form Design ◽  
Capsule Suspension ◽  
Final Dosage Form

Drug nanocrystals offer an attractive approach for improving the solubility and dissolution rate of poorly soluble drugs which accounts for nearly 40 % newly discovered drug molecules. Both methods for manufacturing drug nanocrystals have high industrial acceptability for being simple and easy to scale which is evident from the number of approved products available in the market. Ability to modify multiple aspects of dosage form like bioavailability, release pattern and dosage form requirement along with flexibility in choosing final dosage form starting from the tablet, capsule, suspension to parenteral one, have made nanocrystal technology one of the very promising and adaptable technology for dosage form design.

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