Data integrity. Those in the pharmaceutical industry have been hearing that phrase a lot as of late. (In fact, I fully expect the phrase to be added to the Webster’s English Dictionary next to a cartoon of a quizzical- looking scientist in the very near future!) Entire conferences and seminars are devoted to delving deep into the meaning, the application, and the support of this topic.
Effective technology transfer protocols share the knowledge and capability of a given API manufacturing process and lay the foundation for the next stage of development. They also enable Contract Development and Manufacturing Organizations (CDMOs) to plan, allocate resources and successfully complete the work.
Besides being a new expectation by regulatory agencies Good Clinical Practice (GCP), Quality by Design (QbD) and Risk-Based Quality Management (RBQM) concepts are receiving attention world-wide. According to FDA and EMA guidelines, Key Risk Indicators (KRIs) and Critical to Quality (CTQ) metrics should focus on safety of research subjects and data integrity.
Stability is a critical quality attribute of pharmaceutical products and is a function of many factors, including the active drug substance itself, the excipients used within the formulation, the manufacturing process employed and the drug product’s container closure system.
PYRAMID Laboratories located in Costa Mesa, California offers a wide range of parenteral manufacturing services including aseptic vial and syringe filling, as well as lyophilization capabilities, for both clinical and commercial products.
, , ,
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. These products may include “single-entity” items such as monoclonal antibodies mixed with a therapeutic chemotherapy drug, devices impregnated or coated with drugs such as drug eluting stents, pacing lead with steroid-coated tip, catheter with antimicrobial coating, transdermal patch and or prefilled drug delivery systems such as insulin injectors.
Last mile distribution of pharmaceutical products at room temperatureA is challenging due to the shipping conditions and environmental weather conditions. Especially the management of multiple product temperature shipping ranges and handling of temperature excursions require special attention by the wholesalers, Marketing Authorization Holders (MAHs), logistic service providers (LSPs) and points of dispensing (e.g. pharmacy, hospital, clinic, dispensing doctor etc.).
This quarterly review on New Drug Applications contains data for applications approved for the first time during the first quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics. A total of 28 applications were approved by FDA during these three months.
In today’s world of significant pressure to deliver cost effective clinical trials in a highly competitive and fast paced environment, sponsors face many competing influences in developing the appropriate sourcing strategy that balances risk, reward and cost.
Revolutionary advances in healthcare science and technology have led to a host of novel therapies, and to the increasingly complex research needed to develop them. The methods and tools used to conduct and monitor clinical trials need to keep pace; machine learning is playing a vital role in these advances.