A Brief History of the GMP
Science Pharma Blog
by @dmin
1w ago
Nowadays in the pharmaceutical industry the rules of Good Manufacturing Practice are something obvious. Quality manufacturing systems and the safety of the medicines are a priority for drug product manufacturers. However, it should be stated that the beginnings of GMP were developed on a number of tragedies. How the FDA pioneered the development of GMP? During the XX century, when the first medicines were released to the market the pharmaceutical industry started to develop dynamically. Initially, although it is hard to believe, there was no scrutiny of how medicines were produced. No attent ..read more
Visit website
From crisis to hope. Restoring mental wellness in a post-pandemic world
Science Pharma Blog
by @dmin
2M ago
The catalysts for deterioration: mental health puzzles The events of recent years have left a deep mark on our psyche. The safety measures taken to stop the pandemic in the years 2020-2021 have had a significant impact on our lives. Society had to confront lifestyle changes, uncertainty about the future, conflicts, domestic violence, and relationship breakups. This included job loss, difficulties finding new employment, prolonged financial constraints, property sales, and getting into debt. This was the reason for a significant deterioration of mental health, manifested by depressed mood, stre ..read more
Visit website
QPPV – the key player in Pharmacovigilance
Science Pharma Blog
by @dmin
4M ago
QPPV – this mysterious abbreviation identifies the most crucial person involved in the whole process of monitoring of safety of drug products, that is pharmacovigilance. The Qualified Person Responsible for Pharmacovigilance (QPPV) is responsible for the creation and management of the whole system ensuring the safe use of medicinal products both in humans and animals. In this article, we would like to describe in scratch the role and responsibilities of the QPPV. Who can become the QPPV? According to European legislation QPPV shall be: a natural person, adequately qualified, at permanent and ..read more
Visit website
Replace, Reduce, Refine. Animal testing in drug development.
Science Pharma Blog
by @dmin
4M ago
In order to introduce a new medicine to the market, the applicant must demonstrate that the proposed product is safe and effective. This is done by presenting the set of quality, non-clinical and clinical data obtained during the developmental studies, which are then evaluated by regulatory authorities. The volume of the data required, impacting the type and extent of studies, depends on the medicine, which is going to be registered. For small-molecule drugs containing  active substances, which are already present in other registered medicinal products, the amount of required data is rath ..read more
Visit website
From crisis to hope. Restoring mental wellness in a post-pandemic world
Science Pharma Blog
by @dmin
5M ago
The catalysts for deterioration: mental health puzzles The events of recent years have left a deep mark on our psyche. The safety measures taken to stop the pandemic in the years 2020-2021 have had a significant impact on our lives. Society had to confront lifestyle changes, uncertainty about the future, conflicts, domestic violence, and relationship breakups. This included job loss, difficulties finding new employment, prolonged financial constraints, property sales, and getting into debt. This was the reason for a significant deterioration of mental health, manifested by depressed mood, stre ..read more
Visit website
How to increase the safety of used cosmetics? A few words about cosmetovigilance
Science Pharma Blog
by @dmin
5M ago
Every day, a lot of people experience side effects after using cosmetics, but not everyone knows that they can report them to the responsible authorities. Why reporting adverse reactions is important and how it affects the safety of cosmetics? If you want to find out what cosmetovigilance is – we invite you to read the article. Pharmacovigilance vs cosmetovigilance – what is the difference? The term “pharmacovigilance” defines activities related to the collection, detection, evaluation, surveillance and prevention of adverse drug reactions. Recently, attention has also been focused on the saf ..read more
Visit website
Safety management of adverse reactions from clinical trials – what you need to know
Science Pharma Blog
by @dmin
5M ago
Safety management is key to any clinical trial and an utmost obligation to any pharmaceutical company introducing new medicinal products to the market. Whilst conducting a clinical trial, safety of all subjects is paramount, therefore best efforts should be made to capture any safety issues. All safety aspects have to be analyzed in the study protocol and approved by Competent Authorities (CAs) before any actions are taken or any subject is enrolled. Changes to previously approved safety plan have to be recognized by CAs. Drug safety responsibilities with regard to identification and handling ..read more
Visit website
Medicinal products advertisement – what is it and what requirements must it fulfill?
Science Pharma Blog
by @dmin
5M ago
Nowadays it is difficult to imagine an economic entity functioning without using any form of advertisement. What about medicinal products? Do life-saving and life-enhancing products also need advertising? Do medicines which have pervaded our daily lives need to be additionally advertised? On the other hand, how do we know whether to choose company A’s medicine or company B’s medicine for a headache? The rules for advertising medicinal products are laid down by the Act of 6 September 2001 Pharmaceutical Law and the Regulation of the Minister of Health of 21 November 2008 on adver ..read more
Visit website
Skin products – What’s new in the ICH Q3D Guideline For Elemental Impurities?
Science Pharma Blog
by @dmin
5M ago
Have you heard about the new version of the ICH Q3D Guideline for Elemental Impurities? Do you know, it was adopted on 24 March 2022 by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA), published on 2 May 2022 and came into force on 24 September 2022. The document introduces limits for elemental impurities present in cutaneous and transcutaneous medicines. It also corrects some of the permitted daily exposures (PDEs) for other routes of administration. In this article we would like to present some of the details of these changes and see, how th ..read more
Visit website
Is market analysis important for pharmaceutical project success?
Science Pharma Blog
by @dmin
5M ago
Big pharma has the unlimited budgets, but is it true? In 2012 the medical and patient world held its breath because of Sanofi’s new product launch – Zaltrap (afibercept), a medicinal product registered for the treatment of colon cancer and its price of 9600 $/month. The price of Avastin (bevacizumab), its closest competitor, was half of its price, since Sanofi’s treatment was so expensive, oncologists turned down the idea of using it. This situation forced Sanofi to slash the price in half, but neither this helped in this failed launch. Another example of overpricing is Glybera (alipogene tipa ..read more
Visit website

Follow Science Pharma Blog on FeedSpot

Continue with Google
Continue with Apple
OR