Affaires réglementaires pharmaceutiques : accès libre

On August 21, 2015, the Center for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) circulated draft guidance on Statistical Principles for Clinical Trials in Pharmaceutical Development for public comments. The draft guidance is to assist the sponsor for providing accurate and reliable assessment of a test treatment under investigation in China. The draft guidance focuses on study designs, basic considerations for on-going trials, data management, and statistical principles for data analysis and reporting. In this article, we intend to comment on the draft guidance and provide constructive input and recommendations whenever possible.

Pseudomonas aeruginosa is an opportunistic pathogen that can cause severe hospital-acquired infections, especially in immune-compromised hosts. P. aeruginosa is notorious for its resistance to antibiotics. Exoenzyme S is one of the several toxins involved in Spreading of infections in burns. It’s been revealed that deletion of genes encoding the components of exoS, in wild-type P. aeruginosa, confers hyper susceptibility to anti phagocytic agents. Antimicrobial and antifungal properties of some herbal medicines were numerously reported. In this study the effect of Satureja khuzestanica extract, an endemic plant of Iran, on the expression level of exoS gene in P. aeruginosa were investigated. For this purpose, MIC was determined for P. aeruginosa. Then, bacteria were treated with S. khuzistanica extract. ExoS and gyrA genes expression in treated and non-treated bacteria, before and after expose was evaluated using RT-PCR technique.

Surprisingly, the expression level of exoS gene was decreased in the presence of S. Khuzestanica. However, the expression of gyrA gene that was used as an internal control was not altered before and after treatment with this herb. Based on the results, S. Khuzestanica could play a, major role in lowering the P. aeruginosa resistance to drugs, by reducing exoS gene expression. According to results of current research we hope in future be used it to the clinic with a wider range as a complementary therapy and also for surgery operation and etc.

Currently, it is necessary to increase harmonization efforts in setting regulatory requirements, inspecting and evaluating GMP compliance, licensing manufacturing sites, recalling defective batches and increasing the exchange of information due to the increased globalization regulatory authorities. PIC/S offers attractive and stable platform to respond such challenges of the globalization. PIC/S actively encourage networking by organizing a “PIC/S GMP Forum” which allow non-member authorities, professional and other organizations to meet informally with the PIC/S Committee. PIC/s has established harmonized guide on GMP requirements for inspectorate and industry. There is the complementarity co-operation between the PIC/S and other organization. PIC/S participating authority co-operates actively and avoids the duplication of his member’s efforts. Till date, 46 countries are the member of the PIC/S and 10 countries are under Accession and Pre-Accession Procedure. PIC/S provide the sharing of the inspection report between the member authorities which allow them to prove their GMP facility equivalent to PIC/S standard and resulting into the reduction of the number of inspection and duplication of the inspection. Joining to PIC/S will endorse the Indian pharmaceutical companies to be reliable exporters of quality medicines globally. While for Indian Pharma Companies to meet the PIC/S requirement would not be like cakewalk especially for MSME Pharma segment that needs to upgrade their GMP facilities. Thus it will be challenging for stake holders to join PIC/S but simultaneously there will be bigger hurdles of not joining the PIC/S. While approaching to PIC/S, a careful examination is needed by India during export as maintaining high quality standards for export markets. PIC/S is bringing a great revolution in the GMP standards to establish the high quality in the drug product and thus INDIA should become the member of PIC/S to raise its GMP standards as it is recognized as ‘power house’ of pharmaceutical manufacturing.

Supervision provides a foundation for future workers to learn practical skills from a qualified professional, and is essential for the development of a profession. Supervision is also very much essential for developing workforces. Recently CDSCO has proposed to create an IT enabled system for online submission of various information on clinical trials to streamline the process of approval, maintaining comprehensive database and monitoring The clinical trials for ensuring the protection of rights, safety and well beings of trial subjects and authenticity of the data generated. Looking at the current regulatory environment of clinical trial in India, it is very much important to collate all the information related to four major domains of clinical trial to bioequivalence study captured online in an organized manner. These domains are: Sponsor/ CRO, Investigator, Ethics Committee (EC) and Patient/ volunteer. In order to get access to all the information, all the sponsors/CROs, Investigators and Ethics Committees are required to put the information in a common repository related to a particular CT which will be updated by the stakeholders on day to day basis.

The efforts of the Indian Regulators towards ensuring the patient safety and data credibility are discussed in the present study.

Helicobacter pylori are component of class 1 carcinogens and there is a close association between the incidence of gastric cancer and high prevalence of infection with this bacterium. The risk of gastric cancer associated with H. pylori infection in industrialized and developing countries are estimated to be 80% and 70% respectively. CagA is the important virulence factor in this bacterium and all of the strains involved in gastric cancer are CagA positive. This factor is secreted into host cells by type IV secretion system. CagA and type IV secretion system in H. pylori encoded by the cag pathogenicity islands (cag PAI) that encodes 30 proteins which are necessary for the pilus formation and function of type IV secretion system, so regarding to the role of this secretion system in secreting CagA and its function in pathogenesis and cancer development in humans and the role of different proteins of this secretion system such as canal and pilus formation and their necessity for function of these structures, it is possibly they are be appropriate candidates for design vaccine, because with inhibiting these proteins can stop canal and pilus formation and finally hinder CagA secretion into the host cells.

To identify the essential structural requirements in 2D chemical space for the modulation of the CXCR4 antagonists of Substituted N-(1H-benzimidazol-2ylmethyl)5,6,7,8-tetrahydro-8-quinolinamines. The statistically significant model showed an internal predictive power of 81 % and a predictivity for the external test set of about 79%. It reveals that carbon chain connected should be directly attached with benzimidazole ring for maximal determining activity. Three QSAR models were developed for substituted tetrahydro-8-quinolinamines derivatives based on theoretical molecular descriptors calculated solely from the structures of substituted tetrahydro-8-quinolinamines compounds. The QSAR results showed satisfactory statistical quality.

Extensive research is conducted to evaluate the safety and efficacy of candidate drugs prior to marketing and distribution, but few epidemiological studies have examined the occupational health of production workers who manufacture these drugs. This paper reviewed the occupational health research published during 1973-2014 regarding adverse health outcomes in pharmaceutical manufacturing workers. Most investigations were prompted by suspected disease clusters. Workers generally had a better mortality experience than their referent populations, but they experienced adverse health outcomes including cancer, endocrine dysfunction, cancer, and liver disease. However, most studies lacked detailed occupational exposure data, and they failed to identify the chemicals used in drug manufacture, including the active pharmaceutical ingredients (APIs). Integrated occupational health research is needed to evaluate exposures and long-term health outcomes among these workers. Since manufacturing operations are frequently outsourced to plants in Asia, this research could inform mitigation measures to protect production workers in this global industry.