Year: 2019
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Fentanyl Counterfeiting – Global threat
Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health. Counterfeit fentanyl pills are showing up on the streets and Drug Enforcement Administration (DEA) considers fentanyl-containing…
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Paracetamol: Dangerous When Not Used Correctly
Paracetamol, also known as acetaminophen and APAP, is a medication used to treat pain and fever. It is typically used for mild to moderate pain relief. It is often sold in combination with other medications, such as in many cold medications. Paracetamol is an effective, simple analgesic that is well tolerated by adults and children…
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28. Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER) and Periodic Adverse Drug Experience Report (PADER) – Introduction
What is PSUR/PBRER? A Periodic Safety Update Report or Periodic Benefit-risk Evaluation Reports are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the…
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Montelukast: Risk Of Neuropsychiatric Reactions
Montelukast is the leukotriene receptor antagonist. It works by blocking the action of leukotriene D4 in the lungs resulting in decreased inflammation and relaxation of smooth muscle. It is used for a number of conditions including asthma, exercise induced bronchospasm, allergic rhinitis, and urticaria. It is mainly used as a complementary therapy in adults in…
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27. Development safety update report (DSUR)
What is a DSUR? The development safety update report (DSUR) is pre-marketing periodic report which covers safety information of drugs, biological, vaccines and combo products under development (including marketed drugs that are under further study) among the ICH regions. DSUR for single active moiety and combined products: A single DSUR including safety data from all…
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26. NDA and ANDA Annual reports
New Drug Application (NDA): The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved,…
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Why we should never use Adult medications in children?
We need to be very careful when giving any medicine to an infant or a child. Even over-the-counter (OTC) medicines are serious medicines. Children cannot be considered as miniature adults and adult medications should never be used in children as children’s responds to drugs differently than adults. Only paediatric medications should be used in children…
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25. CSR reports
The clinical study report (CSR) is a crucial document in the drug development and regulatory submission process. According to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline E3, a CSR is an integrated report of a study of any therapeutic, prophylactic or diagnostic agent in which…
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24. Aggregate reporting- IND annual reports
Investigational New Drug (IND): Once the preclinical stages including the required short term animal studies have been completed, the drug is ready to be moved into human testing. Before this can happen permission for human research must be obtained by submitting an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). An…
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23. Aggregate reporting – Introduction
Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide. The aggregate safety reports are presented to regulators as soon as the medicine is marketed anywhere in the world and enables understanding of risk and benefit profile…