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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Current Issue

Volume 9, Issue 1 (2020)

    Editorĺs Note Pages: 1 - 1

    Editorial Note for Journal of Pharmaceutical Regulatory Affairs: Open Access

    Swarupananda Mukherjee

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    Short Communication Pages: 1 - 3

    Detecting Falsified Viagra Using Miniaturized Consumer Near-Infrared Spectroscopy

    Agata Sroka*, Dr. Kotaro Ishizaki and Dr. Zofia Baranczuk

    The miniaturized Near-Infrared Spectroscopy (NIRS) enables convenient, non-destructive and real-time testing of medicines that are circulating on the field or throughout the supply chain. We have successfully been able to detect falsified Viagra using a new low-cost, consumer-type NIRS. In like manner, we have distinguished the original Viagra from its generic versions with the same dose. This is a promising way of ensuring medicines authenticity by looking at their chemical ‘fingerprints’. Portable screening technologies for medicine quality assurance on the field or throughout the supply chain are currently growing and complementing the current approach for combating the falsified products, i.e., safety features on the packaging and laboratory analysis of suspect samples. In total, 78 spectra of Sildenafil-based tablets were recorded and classified using the K-Nearest Neighbors algorithm that relies on the Euclidean distances between measured values. Accuracy of our model was assessed using cross validation and bootstrapping techniques. In result, the miniaturized NIRS correctly ordered all tablets according to their manufacturer and indicated the falsified tablets, which spectra not only differed in shape from the authentic versions, but also show high spread in chemo-physical characteristics, which suggest poor manufacturing practices of the falsified products.

    Short Communication Pages: 1 - 2

    Walking in the Field of Pharmaceutical Regulatory in Albania

    Ilda Mallkuci*, Narvina Sinani and Ina Thereska

    Background: Globally and locally the pharmaceutical industry is highly regulated. In Albania the regulatory requirements are changing with different amendments of Low and Regulations to ensure the supply with high pharmaceutical quality, safety and efficacy of medicines. The accelerated procedure for medicines that come from EU/FDA, has given to the patients access to new medicines such as orphans and biosimilars in a very short time from their first marketing authorization. In this way the patient can achieve new pharmaceuticals which are safe, efficient and qualitative and the most important point innovative medicines that are authorized for marketing in USA and EU.

    Methods and Results: Statistical data points indicate that in Albania from 2014 - 2018 are authorized for marketing: EU Centralized procedure 267 medicines and FDA 13 medicines, from 1666 authorized for marketing in total. From the remaining medicines, 1386 of them are from EU countries or West Balkans region. The trend of new medicines that are submitting at the Albanian Agency, from different pharmaceutical companies has increased from 2014 to present day, with new biosimilars, orphans and new medicines for acromegaly or antineoplastic agents.

    Conclusion: In Albania we have an urgent need for regulations that govern interchangeability/substitutability of biosimilars, extrapolation of their indications, and new legislation on orphans. The purpose is to find common elements in the most varied regulatory systems that enable companies to identify the documents and information required by international regulators and understands technics that can help to reduce cost and time in the marketing authorization approval process globally. An analysis of the legislation of the different countries and an identification of the common elements must be discussed in a practical way.

    Recommendations: Approaching the Albanian legislation with EU legislation regarding innovative medicines which can promote competition between different medicines for the same pathology reducing costs of therapy.

    Volume 9, Issue 2 (2020)

      Short Communication Pages: 1 - 3

      Detecting Falsified Viagra Using Miniaturized Consumer Near-Infrared

      Agata Sroka*, Dr. Kotaro Ishizaki and Dr. Zofia Bara├ů?czuk

      The miniaturized Near-Infrared Spectroscopy (NIRS) enables convenient, non-destructive and real-time testing of medicines that are circulating on the field or throughout the supply chain. We have successfully been able to detect falsified Viagra using a new low-cost, consumer-type NIRS. In like manner, we have distinguished the original Viagra from its generic versions with the same dose. This is a promising way of ensuring medicines authenticity by looking at their chemical ‘fingerprints’. Portable screening technologies for medicine quality assurance on the field or throughout the supply chain are currently growing and complementing the current approach for combating the falsified products, i.e., safety features on the packaging and laboratory analysis of suspect samples. In total, 78 spectra of Sildenafil-based tablets were recorded and classified using the K-Nearest Neighbors algorithm that relies on the Euclidean distances between measured values. Accuracy of our model was assessed using crossvalidation and bootstrapping techniques. In result, the miniaturized NIRS correctly ordered all tablets according to their manufacturer and indicated the falsified tablets, which spectra not only differed in shape from the authentic versions, but also show high spread in chemo-physical characteristics, which suggest poor manufacturing practices of the falsified products.

      Research Pages: 1 - 5

      Analytical Method Development and Validation of Preservative Benzalkonium Chloride in Ciprofloxacin Eye Drops

      Akter S, Ferdous MD, Sadikuzzaman MD, Mirzan Rahaman MD and Ashrafudoulla MD*

      An accurate, precise, linear, specific and cost effective simple HPLC method has been developed and validated for estimation of Benzalkonium Chloride. Separation of the Preservative was achieved on a L10 column (Dimension: 15 cm × 4.6 mm, 5 µm particle size) using a mobile phase consisting of a mixture of Phosphate buffer (PH 5.5) and acetonitrile (40:60, v/v). The flow rate and detection wavelength were 1 mL/min and 210 nm respectively. The linearity was found in the concentration of 0.05, 0.08, 0.10, 0.12, 0.15, mg/mL as 50% solution of Benzalkonium Chloride with a correlation coefficient (R2) of 0.999. The retention time of Benzalkonium Chloride-1 and Benzalkonium Chloride-2 were 5.965 and 6.993 minutes respectively. The predicted method was validated as per the International Council for Harmonization Guidelines (ICH) for the parameters: Linearity, Accuracy, Precision, Robustness and Specificity. This method can be used for routine analysis of quality control of Benzalkonium Chloride in Ophthalmic dosage form.

      Review Pages: 1 - 8

      Schedule I Control Status Does Not Impede Legitimate Nonclinical Research

      Gauvin DV

      Background: There are many misconceptions about conducting research with Schedule 1 (CI) controlled substances to conduct nonclinical research in the US. Research design cannot be driven by financial constraints. Aim: The notion that current regulatory control of CI drugs hamper, hinders, or restricts legitimate nonclinical research in the U.S. may reflect a lack of understanding of the procedures in place to study these drugs. Review: Nonclinical research must comply with the Good Laboratory Practice (GLP) guidelines (21 CFR §58) of the U.S. Food & Drug Administration (FDA). Protocol development under the GLPs provides the information and details required under the Controlled Substances Act (CSA) for submission to the two drug regulating agencies relevant to the approvals required prior to the first dose administration on the study. Under 21 USC § 823(f), the registration applications by practitioners wishing to conduct Schedule I research shall be referred by the Secretary of HHS (FDA), who shall determine the qualifications and competency of each practitioner, as well as the merits of the research protocol. Additionally, a formal verification of the professional standards of the Study Director and the research facility conducting the study will be conducted by the DEA. These additional two requirements differentiate studies conducted with CI drugs and all other schedule-controlled drugs. In the U.S., the security requirements for storage under current DEA administrative regulations are equivalent for both CI and CII drugs. Conclusion: An informed researcher conducting nonclinical studies with CII– CV drugs can easily comply with current drug control requirements to conduct research with CI drugs in the US.

      Review Pages: 1 - 6

      Product Labeling of Drugs Commonly Administered to Children and Adults

      Zimmerman KO*, Benjamin Jr. DK, Becker ML, Anand R and Hornik CP

      Obesity is a major public health problem that can affect drug disposition and dosing, particularly in vulnerable pediatric populations. Despite potentially detrimental consequences from inappropriately dosed drugs in children with obesity, drug product labels largely fail to include dosing or guidance specific to this population. Failure to include this information results in an increased incidence of adverse events, and concerns from treating physicians regarding their ability to provide appropriate care for children with obesity. Using data from the National Institute of Child Health and Human Development-funded Pediatric Trials Network (PTN), we explore possible ways to improve drug labeling in children with obesity. In order to improve health outcomes of children with obesity, carefully designed and executed PK trials and comprehensive PK analysis strategies are needed. Early collaboration with the Food and Drug Administration may be helpful in developing studies and analyses that are most beneficial for child health. This collaboration is particularly important for drugs that treat potentially life-threatening diseases, where inclusion of PK and dosing on the drug label is vital. We hope that increasing the body of knowledge on drug dosing in children with obesity will open the door to regulatory guidance based on extrapolation or population-specific PK studies, similar to other currently-recognized special populations. Given the magnitude of the pediatric obesity pandemic, recognition as a special population will offer substantial public health value.

      Review Pages: 1 - 4

      Physico-chemical and Preliminary Phytochemical Study of Seeds of Datisca cannabina Linn (Datiscaceae) from Himalaya Region

      Ijaz S*, Perveen A, Kousar S and Ghaffar N

      The indigenous medicine involves the use of various plant extracts or the bioactive constituents, phytochemical analysis of such plants confirm the presence of different phytochemicals. Datisca cannabina Linn belong to family Datiscaceae. The whole plant is used in medicines in a mixture forms. The aim of this study was to assess the seeds of Datisca cannabina physicochemically and phytochemically. Maximum bioactive compounds (carbohydrate, alkaloids, proteins and aminoacids, phenolic compounds, flavonoids, glycosides fixed oil and terpenoids) were detected in the extract of methanol, chloroform, acetone and water. Presence of several phytochemical compounds showed high therapeutic potential of Datisca cannabina and it can take for medicinal purposes after determining the seeds pharmacologically

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