Pharma Blog
Effective Design of Clinical Trials | FDA
The 1962 FD&C Act Prior to 1962, drug safety was the primary concern, but the act revolutionized the landscape by demanding substantial evidence of a drug’s effectiveness. This shift led to the requirement of “adequate and well-controlled studies” – a cornerstone of modern clinical research. 𝗔𝗱𝗲𝗾𝘂𝗮𝘁𝗲 𝗮𝗻𝗱 𝗪𝗲𝗹𝗹-𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝗦𝘁𝘂𝗱𝗶𝗲𝘀: 𝗧𝗵𝗲 ... Read More
Stability Data and Evaluation of Finished Pharmaceutical Products
Stability Studies: A Brief Introduction Stability studies are crucial for determining the shelf life and storage conditions of pharmaceutical products, ensuring their efficacy and safety throughout their lifespan. Long-term and accelerated studies are conducted to evaluate how products respond to various environmental conditions. Data from these studies help establish expiration ... Read More
Role of pKa and pH Values in HPLC
One of the critical factors influencing the success of an HPLC analysis is the control of pH, which directly impacts the ionization state of analytes. The pKa value of a compound, indicating its acid dissociation constant, plays a pivotal role in this process. pKa: A Key Parameter The pKa value ... Read More
Choice of Analytical Techniques for Cleaning Validation
Visual Inspection: Visual Inspection is the examination of the dried equipment under suitable lighting conditions by personnel with appropriate standards of vision. Generally, it is used when it has been demonstrated that a calculated MACO would leave a visible residue as it is not intuitive that a validated method of ... Read More
Classification of Elemental Impurities
The elemental impurity classes are: Class 1: The elements, As, Cd, Hg, and Pb, are human toxicants that have limited or no use in the manufacture of pharmaceuticals. Their presence in drug products typically comes from commonly used materials (e.g., mined excipients). Because of their unique nature, these four elements ... Read More
Potential Sources of Elemental Impurities
In considering the production of a drug product, there are broad categories of potential sources of elemental impurities. The following diagram shows an example of typical materials, equipment and components used in the production of a drug product. Each of these sources may contribute elemental impurities to the drug product, ... Read More
Metformin Tablets | Drug Digest
Current treatment guidelines recommend initiating metformin as first line pharmacotherapy unless a contraindication or intolerability exists. Metformin consistently reduces A1C levels by 1.5% to 2.0% and FPG levels by 60 to 80 mg/dL (3.3 to 4.4 mmol/L) in drug naive patients with A1C values of approximately 9%. Metformin does not ... Read More
Marochym-200 (Trypsin & Chymotrypsin) Tablets
Composition: trypsin and chymotrypsin are oral proteolytic enzymes that hasten the repair of traumatic, surgical and orthopedic procedures. The combination of these two enzymes in this product grants it anti-inflammatory, anti-edematous, fibrinolytic, antioxidant and anti-infective properties. Mechanism of action: Trypsin and chymotrypsin resolve swelling by exerting proteolytic action on wounds. ... Read More
DAYVIGO (Lemborexant) for Insomnia
DAYVIGO (lemborexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Lemborexant is a competitive antagonist of both orexin receptors, OX1R and OX2R, with a higher affinity for OX2R. It belongs to the pharmacologic class of orexin receptor antagonists. The orexin neuropeptide signaling ... Read More
SEROQUEL (Quetiapine Fumarate) | Antipsychotic Agent
Indications: Notes: Serious Warnings and Precautions: Monitoring and Tests: Others: Precautions: SEROQUEL can cause serious side effects including: Note: SEROQUEL is not a cure, but it can help manage symptoms. The following may interact with SEROQUEL: Usual dose: SchizophreniaStarting dose is 25 mg, twice daily. The recommended dose range is ... Read More
Adverse Drug Reaction (ADR)
Health Canada: Adverse reactions are undesirable effects to health products (including drugs, medical devices and natural health products). WHO: any noxious and unintended response to a medicinal product. Why are ADRs so important? Common: Expensive: Serious: Often preventable. Risk factors for the development of an ADR include: Use a systematic ... Read More