№ files_lp_4_process_3_126995
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Scientific pharmaceutical development report describing formulation design, process optimization, quality attributes, stability evaluation, and regulatory considerations for dexamethasone tablets 20 mg developed using a Quality by Design approach for potential regulatory submission.
Year:
Not specified
Region / Market context:
United States, European Union, India
Field:
Pharmaceutical development
Document type:
Pharmaceutical development report
Drug product:
Dexamethasone Tablets 20 mg
Therapeutic area:
Oncology and anti-inflammatory therapy
Indication mentioned:
Multiple myeloma adjunct therapy
Development approach:
Quality by Design (QbD)
Reference product:
HEMADY™ (Dexamethasone) Tablets 20 mg
Reference product manufacturer:
Dexcel Pharma Technologies Ltd, Israel
Reference product distributor:
Acrotech Biopharma Inc, USA
Active pharmaceutical ingredient:
Dexamethasone (micronized API)
Key excipients:
Lactose Monohydrate, Corn Starch, Povidone, Sodium Starch Glycollate Type A, Magnesium Stearate
Manufacturing process:
Direct blending and compression
Critical Material Attribute (CMA):
API particle size distribution below 10 microns
Critical Process Parameter (CPP):
Blending time (15 minutes pre-lubrication, 5 minutes lubrication)
Critical Quality Attributes (CQA):
Blend flow, hardness, dissolution
Stability testing conditions:
40°C ± 2°C / 75% RH ± 5% RH for 6 months
Packaging evaluated:
Bottle and blister pack
Regulatory framework referenced:
ICH Q8 (R2), ICH stability guidelines
Supporting regulatory sources:
US DMF, CEP, USP, BP, Ph.Eur
Related patent referenced:
US10,537,585 B2 (21 January 2020)
Primary objective:
Development of a cost-effective bioequivalent dexamethasone tablet formulation
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / City:
Not specified
Subject:
Supply chain optimization for plastic waste management
Document Type:
Instruction manual / Case study guide
Institution / Organization:
Not specified
Author:
Not specified
Target Audience:
Researchers, engineers, and analysts in waste management and recycling
Effective Period:
Upon publication
Reference Manuscript:
Designing Cost-Effective Supply Chains for Plastics at the End-of-Life
Software Mentioned:
P-Graph Studio
Data Requirements:
Excel file with units, operations, and distances
Cost Analysis Included:
CAPEX and OPEX assessment
Year:
2023
Region / City:
Seattle-Tacoma, Gary, Renton
Subject:
Civil engineering, Public works, Construction materials
Document Type:
Article
Organization / Institution:
N/A
Author:
Nico Sutmoller
Target Audience:
Construction professionals, engineers, public works agencies
Effective Date:
N/A
Date of Approval:
N/A
Date of Changes:
N/A
Year:
2024
Region / city:
United Kingdom
Topic:
Health technology assessment
Document type:
Appeal hearing report
Organization:
National Institute for Health and Care Excellence (NICE)
Author:
NICE
Target audience:
Healthcare professionals, industry representatives, public
Period of validity:
Not specified
Approval date:
23 September 2024
Date of changes:
Not specified
Decision: Paddy Lee – Australian Harness Racing Rule 190(1) – Dexamethasone Positive in Keayang Xena
Date:
1 March 2024
Region/City:
Melton, Australia
Subject:
Horse Racing, Doping Violation
Document Type:
Legal Decision
Authority/Institution:
Harness Racing Victoria, Victorian Racing Tribunal
Author:
Mark Howard, Registrar, Victorian Racing Tribunal
Target Audience:
Horse Racing Professionals, Legal Experts
Period of Validity:
3 February 2023
Date of Approval:
1 March 2024
Year:
2022
Region / City:
Not specified
Topic:
Health / Medication Side Effects
Document Type:
Medical Information
Organ / Institution:
Not specified
Author:
Not specified
Target Audience:
Healthcare professionals, patients
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A medical source providing information on the potential side effects of Velcade, Revlimid, and Dexamethasone, organized by frequency and severity.
Year:
2016
Region / city:
Australia
Topic:
Multiple myeloma treatment
Document type:
Submission for listing consideration
Organ / institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Takeda Pharmaceuticals Australia Pty Ltd
Target audience:
PBAC, healthcare professionals
Period of validity:
Ongoing treatment
Approval date:
15 November 2016
Date of changes:
N/A
Year:
2015
Region / City:
Australia
Topic:
Pharmaceutical submission
Document Type:
Submission for Authority Required Listing
Institution:
Medical Services Advisory Committee (MSAC)
Author:
Allergan Australia Pty Limited
Target Audience:
Healthcare professionals, Medical Services Advisory Committee, Pharmaceutical Regulators
Period of Validity:
Indefinite
Approval Date:
Not specified
Modification Date:
Not specified
Treatment:
Diabetic Macular Oedema (DME)
Indication:
Visual impairment due to centre-involving DME
Restriction:
Authority Required (streamlined)
Clinical Criteria:
Diabetic Macular Oedema, Reduced Visual Acuity ≤ 6/12 Snellen
Population Criteria:
Adults, pseudophakic or cataract surgery scheduled
Price:
Special pricing arrangements
Limitations:
Discontinuation of treatment if ≥ 15 letter decrease in best corrected visual acuity (BCVA)
Formulation:
700 µg dexamethasone in a solid polymer drug delivery system
Comparator:
Ranibizumab, Bevacizumab
Context:
Submission for PBS listing of dexamethasone implant for treating diabetic macular oedema in patients with pseudophakic eyes or those scheduled for cataract surgery.
Note:
Year
Document type:
Product Information
Organ / institution:
European Medicines Agency
Target audience:
Healthcare professionals, patients
Year:
2014
Region / city:
Australia
Topic:
Pharmaceutical product submission
Document type:
Application for listing
Organization / institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target audience:
Health professionals, regulatory authorities
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
1 April 2014
Note:
Year
Organization / Institution:
NHS Scotland
Author:
Dr Laura Ryan, Dr John McAnaw, Mr Jim Miller
Target Audience:
Qualified health professionals within NHS Scotland
Changes History:
Eligibility age extended, new conditions added, clarifications made
Clinical Situation:
Acute uncomplicated urinary tract infection (UTI) in non-pregnant females aged 16 years and over.
Year:
2022
Region / City:
Australia
Topic:
Oncology / Hematology
Document Type:
Submission Report
Organ / Institution:
Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Celgene Pty Limited
Target Audience:
Healthcare professionals, regulatory authorities
Validity Period:
Ongoing
Approval Date:
8 April 2022
Amendment Date:
Not specified
Year:
2017
Region / city:
Australia
Topic:
Treatment of moderate to severe plaque psoriasis
Document type:
Resubmission for PBS listing
Authority:
Therapeutic Goods Administration (TGA)
Author:
Celgene Pty Ltd
Target audience:
Healthcare professionals, dermatologists, general physicians
Period of validity:
Ongoing
Approval date:
2017
Date of amendments:
2017
Year:
2026
Region / City:
Europe
Subject:
Product Information
Document Type:
Summary of Product Characteristics
Organization / Institution:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Healthcare professionals
Period of Validity:
Ongoing
Approval Date:
2026
Date of Changes:
2026
Year:
2025
Region / City:
England
Topic:
Emergency contraception
Document type:
Patient Group Direction (PGD)
Organization / Institution:
NHS England
Author:
Dr Cindy Farmer, Michelle Jenkins, Vicky Garner, Gail Rowley, Julia Hogan, Kate Devonport, Chetna Parmar, Helen Donovan, Carmel Lloyd, Clare Livingstone, Kirsty Armstrong, Dipti Patel, Emma Anderson, Dr Kathy French, Dr Sarah Pillai, Alison Crompton, Andrea Smith, Lisa Knight, Bola Sotubo, Tracy Rogers, Sandra Wolper, Jo Jenkins
Target audience:
Pharmacists, Pharmacy Technicians
Effective period:
June 2025 - February 2026
Approval date:
November 2022
Review date:
September 2025
Expiry date:
February 28, 2026
Year:
2023
Region / city:
Europe
Theme:
Pharmaceutical, HIV Treatment
Document Type:
Summary of Product Characteristics
Organization / Institution:
European Medicines Agency (EMA)
Author:
European Medicines Agency
Target audience:
Healthcare professionals, doctors
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2025
Author:
Bahá’u’lláh
Religious Tradition:
Bahá’í Faith
Genre:
Sacred scripture
Form:
Tablets and devotional texts
Primary Themes:
Revelation, divine love, steadfastness, martyrdom, spiritual transformation
Named Individuals:
Muḥammad-‘Alí
Liturgical Element:
Tablet of visitation
Language Style:
Devotional and exhortatory prose
Intended Audience:
Believers and followers of the Cause of God
Historical Context:
Successive divine dispensations and fulfillment of prophetic promises
Name of the medicinal product:
Miraba-S Tablets
Active substances:
Mirabegron (Extended-Release) 25 mg; Solifenacin succinate 5 mg
Pharmaceutical form:
Film coated tablet
Description:
Yellow coloured, round, biconvex, film coated tablet
Therapeutic indications:
Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Posology:
One tablet daily; may increase to two tablets daily after 4 to 8 weeks based on efficacy and tolerability
Dose adjustments:
Maximum once daily in severe renal impairment (CLcr 15–29 mL/min or eGFR 15–29 mL/min/1.73 m2) or moderate hepatic impairment (Child-Pugh Class B); not recommended in ESRD or severe hepatic impairment
Method of administration:
Swallowed whole with water, with or without food; not chewed, divided, or crushed
Contraindications:
Hypersensitivity to mirabegron, solifenacin succinate, or any excipients
Special warnings and precautions:
Risk of increased blood pressure, urinary retention, angioedema, and interactions with CYP2D6 substrates
Drug interactions:
CYP2D6 substrates (e.g., metoprolol, desipramine, thioridazine, flecainide, propafenone); digoxin; warfarin
Fertility:
No human data available; no treatment-related effects observed in animals
Pregnancy:
No adequate studies in pregnant women
Lactation:
No information on presence in human milk or effects on breastfed child
Effects on ability to drive and use machines:
Mirabegron has negligible influence; solifenacin may cause blurred vision, somnolence, and fatigue
Undesirable effects:
Dry mouth, urinary tract infection, constipation, tachycardia, hypertension, urinary retention, angioedema
Reporting of suspected adverse reactions:
Healthcare professionals advised to report adverse reactions
Year:
2021
Region / City:
Global
Topic:
Medicine/Pharmaceuticals
Document Type:
Pharmaceutical Product Information
Organization:
N/A
Author:
N/A
Target Audience:
Healthcare Professionals
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2025
Region / City:
England
Topic:
Emergency contraception, NHS Pharmacy Contraception Service
Document Type:
Patient Group Direction
Organization / Institution:
NHS England
Author:
Dr Cindy Farmer, Michelle Jenkins, Vicky Garner, Gail Rowley, Julia Hogan, Kate Devonport, Chetna Parmar, Helen Donovan, Carmel Lloyd, Clare Livingstone, Kirsty Armstrong, Dipti Patel, Emma Anderson, Dr Kathy French, Dr Sarah Pillai, Alison Crompton, Andrea Smith, Lisa Knight, Bola Sotubo, Tracy Rogers, Sandra Wolper, Jo Jenkins
Target Audience:
Community Pharmacists, Pharmacy Technicians
Effective Date:
29 October 2025
Review Date:
September 2028
Expiry Date:
28 February 2029
Approval Date:
November 2022
Document Status:
Draft
Document Version:
1.0
Change History:
Version 1.0 approved on 20 June 2025
Clinical Condition:
Unprotected sexual intercourse, contraceptive failure
Criteria for Inclusion:
Emergency contraception within 96 hours post-UPS, vomiting after EC
Criteria for Exclusion:
Age under 16, pregnancy, recent childbirth or miscarriage
Cautions:
Fraser guidelines for underage assessments, safeguarding protocols
Context:
A PGD outlining the conditions and procedures for emergency contraception administration by authorized pharmacists and technicians in NHS pharmacies in England.