Pharmacy Times

JULY 22, 2025

By incorporating a patient's genetic profile into therapeutic decision-making, pharmacists can identify optimal drug choices and dosages while minimizing the risk of adverse events (AEs). Developed in partnership with InterSystems, the platform uses proprietary algorithms to personalize drug selection and dosage.

Pharmacy Technician

Express Pharma

JUNE 23, 2025

Most projects fail not in the lab, but in study design, regulatory interpretation, and documentation. How to get it right -A practical framework Start with a Risk Assessment: Map out materials, dosage form, route of administration, and expected interactions. The reason? Many Indian companies skip this step.

Packaging

Pharmacy Times

JUNE 20, 2025

Other documented causes of secondary dysmenorrhea include fibroids, adenomyosis, infection, myomas, obstructive reproductive tract anomalies, and ovarian cysts About the Author Yvette C. Dysmenorrhea, also known as painful menstruation, is the most commonly reported menstrual symptom among females during the reproductive years.

Pharmacy Technician

Pharmaceutical Commerce

JULY 16, 2025

Compounding, by definition, involves customizing medications to meet individual patient needs, such as altering dosage forms or removing allergens. This all leads to an increased risk of adverse events, like contamination, incorrect dosages, or unexpected side effects, simply because production can vary wildly.

Compounding

Pharmacy Times

JULY 18, 2025

Compliance with FDA guidelines, including documenting clinical differences and avoiding investigational GLP-1s, is essential for compounders. It would also be expected that the reason would be documented in the patient’s chart. In other words, the pharmacist can take that determination verbally but must document it.

Compounding

European Pharmaceutical Review

JULY 9, 2025

We offer end-to-end services for small molecule finished dosage forms (FDFs), including sterile and non-sterile liquids, solids, and semi-solids products. This collaborative approach enabled us to implement customised aseptic processing simulations and establish comprehensive documentation for API traceability before production began.

Pharmaceutical Manufacturing

PharmaTech

JULY 17, 2025

Stage 3: dosage form completion & quality evaluation Conduct rigorous physical and analytical testing; 503B batches must meet GMP-level standards. Finalize documentation with full traceability and ensure preparations are quarantined until verified. antineoplastics, allergens).

Compounding

The Thyroid Pharmacist

AUGUST 1, 2025

Women with treated thyroid conditions will likely need to adjust their medication dosage, perhaps multiple times. The ­ IGT and Low Milk Supply Facebook Support Group maintains a listing of galactagogues, including dosages, precautions, and additional resources. Breastfeeding is a state of enhanced thyroid hormone requirement.

Health and Personal Care Stores

STAT

JULY 18, 2025

In briefing documents released earlier this week, FDA staff highlighted their concerns about the ocular issues and suggested lower dosages could offer patients similar efficacy in treating multiple myeloma while lowering the risk of side effects. During

Dosage

STAT

JULY 17, 2025

In briefing documents released earlier this week, agency staff highlighted their concerns about the ocular issues and suggested that lower dosages of Blenrep could offer patients similar efficacy in treating multiple myeloma while lowering the risk of side effects.

Dosage

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day).

Controlled Substances

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage

Pharma Pathway

SEPTEMBER 15, 2022

a Specialty Pharmaceutical Company engaged in Development, Manufacturing and Marketing of quality finished dosages in domestic and International markets is looking for suitable candidates for its formulation facility at Dahej, Bharuch, Gujarat. -Walk-In Interview for Quality Control/Production/ Quality Assurance On 18th Sept’ 2022.

Dosage

PharmaTech

DECEMBER 14, 2022

Procipient is supported with the proper documentation required by pharmaceutical regulatory authorities. Procipient ® (Dimethyl Sulfoxide USP, PhEur ) is the only compendial DMSO specifically for pharmaceutical use.

Dosage

Express Pharma

JUNE 2, 2023

Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all. By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation.

Adverse Reactions

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

Packaging

epicur

DECEMBER 19, 2022

The FDA recently finalized regulatory guidance for compounded animal medications from bulk drug substances for use in non-food-producing animals, impacting the way compounded drugs can be used, documented, ordered, and prescribed. Pharmacists must document why an FDA-approved or indexed product is not being used to compound the medication.

Compounding

Pharma Pathway

FEBRUARY 2, 2023

Candidate should have exposure in handling various dosage forms such as tablets and capsule (ER/ SR IR) / Injectables (Cytotoxic / High potent molecules /drug device combination products) Development of Formulation for ANDA and other regulatory submissions. Our focus is primarily on niche therapeutic areas and complex products.

Dosage

Pharmacy Times

JUNE 28, 2022

Investigators studied the efficacy and safety of eptinezumab-jjmr in the 100 mg and 300 mg intravenous infusion dosages in individuals with 2 to 4 documented unsuccessful prior preventive treatment failures for migraine in the past 10 years.

Dosage

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. All documentation must be kept as supporting evidence. Additional documents included each month. Additional documents included each month. Subscribe a.

Documentation

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. All documentation must be kept as supporting evidence. Additional documents included each month. Additional documents included each month. Subscribe a.

Documentation

Express Pharma

AUGUST 6, 2024

5] Emerging technologies will help record and document data effectively, choose the right regulatory pathways and commercialise safer formulations faster. 2] So, we need to cultivate and incentivise the right talent to build scientific acumen to accelerate progress in FR&D. [3]

Dosage

GMPSOP

JUNE 9, 2024

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

Method Validation

pharmaphorum

OCTOBER 11, 2022

Documentation of detailed descriptions of the ECA population is critical, including the mechanisms and conditions that led to the patients being recorded in the data source. eligible dosages, how the drug is administered, and frequencies of drug intake). Populations and treatment conditions.

Documentation

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage

Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical compounding is a method of preparing personalised medications for patients by mixing the individual ingredients in the exact strength and dosage form required by the patient. It may provide access to discontinued drugs and allows for alternative compounded dosage forms. Test method development.

Compounding

Express Pharma

APRIL 6, 2023

These experts can provide guidance on the specific licensing requirements for the startup’s products, help prepare and submit the necessary documentation, and ensure that the startup is following the correct procedures throughout the licensing process.

Labelling

Quality Matters

NOVEMBER 27, 2023

Qualification threshold: 20 ppm “Use of in-vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms. FDA’s draft guidance document states that all marketed ophthalmic product should follow General Chapter specifications, even where there is not a specific USP monograph for the product.

Documentation

FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). 50,372 at 50,372-73.

Controlled Substances

Pharmacy Is Right For Me

APRIL 4, 2023

Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC). And when the medication was delivered to her home, she realized the dosage no longer matched her regimen. This has been the case since long before the COVID-19 crisis.

Hospitals

GMPSOP

MARCH 8, 2024

– Please make sure that proper documentation is maintained and corrective action is undertaken. The FDA subsequently published several guidance documents regarding this matter. Additional documents included each month. Additional documents included each month. Additional documents included each month.

Documentation

GMPSOP

FEBRUARY 10, 2024

Additional documents are included each month. – Training requirements for each role are identified, documented, approved and kept current. This includes ensuring that references to the version of a given document align with the corresponding entry on the Controlled Document Index. Check out sample preview s.

Health and Personal Care Stores

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.

Documentation

pharmaphorum

SEPTEMBER 7, 2022

The recommended initial dosage is low, with a gradual build up in dosage, so as to reduce possible side effects such as upper respiratory infection, urinary tract infection, and hypertension. Clinical trial results showed a significant reduction in symptoms when people took ozanimod, as compared with a placebo.

Dosage

Pharma in Brief

SEPTEMBER 8, 2022

AbbVie noted that, unlike a CRP, a BRD is not required by the Food and Drug Regulations to “contain identical amounts of the identical medicinal ingredients, in a comparable dosage form”. Guidance Document : Information and Submission Requirements for Biosimilar Biologic Drugs. Links: AbbVie Corporation v.

Biosimilars

Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. Growth of oral solid dosage contract manufacturing in the pharmaceutical industry. Find the leading pharmaceutical solid dose manufacturing companies in contract marketing.

Dosage

GMPSOP

JUNE 16, 2023

According to USP <1224> , method transfer is defined as the documented process that qualifies a laboratory (RL) to use an analytical method originating from another laboratory (TL), regardless of whether it’s internal or external. Additional documents included each month. Additional documents included each month.

Documentation