Express Pharma

JANUARY 16, 2024

DRESS syndrome, mentioned in the IPC alert, is a very rare event that is previously documented in medical literature, both in India and globally. The post IPC alert advises patients to monito possibility of mefenamic acid’s adverse effects: Meftal makers appeared first on Express Pharma.

Adverse Reactions 105

Adverse Reactions Documentation 105

LifeProNow

APRIL 9, 2023

Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. The most frequent hemorrhagic events were gastrointestinal, including rectal hemorrhage (4.2%), hematochezia (3.1%), and hemorrhoidal hemorrhage (1%). Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Adverse Reactions 100

Adverse Reactions Labelling Documentation 100

FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

Express Pharma

JUNE 2, 2023

This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

RX Note

JULY 30, 2023

Adverse Drug Reactions The World Health Organization (WHO) defines an adverse drug reaction (ADR) as 'a drug-related event that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function'. Is it safe?

Adverse Reactions 52

Adverse Reactions Patient Counseling Medical Records Documentation 52

LifeProNow

APRIL 19, 2023

The primary endpoint evaluated in this study is progression-free survival, defined as time from randomization to the first documentation of progressive disease or death due to any cause, whichever occurs first. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.

Adverse Reactions 100

Adverse Reactions Vaccines Immunity Immunization 100

Pharmaceutical Technology

JUNE 15, 2023

During these phases, data is obtained from participants and monitored for adverse reactions or changes to health indicators, such as blood pressure or heart rate. For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document.

Drug Development 52

Drug Development Compounding Adverse Reactions Dosage 52