Cross hypersensivity to NSIADs, Allergic and pseudoallergic reactions.Utai Sukviwatsirikul
Cross hypersensitivity of NSAIDs
Allergic and pseudoallergic reactions
source of info: http://www.si.mahidol.ac.th/th/division/soqd/admin/news_files/423_18_3.pdf
Cross hypersensivity to NSIADs, Allergic and pseudoallergic reactions.Utai Sukviwatsirikul
Cross hypersensitivity of NSAIDs
Allergic and pseudoallergic reactions
source of info: http://www.si.mahidol.ac.th/th/division/soqd/admin/news_files/423_18_3.pdf
คู่มือหลักเกณฑ์การขึ้นทะเบียนตำรับยาแผนโบราณ Guideline Registration Traditional Medicine โดยกลุ่มยาแผนไทยและยาสมุนไพร สำนักยา สำนักงานคณะกรรมการอาหารและยา กระทรวงสาธารณสุข
Stability testing evaluates how the quality of a drug varies over time under different environmental conditions like temperature and humidity. It establishes a re-test period for active ingredients and shelf life for products. Drugs are tested under various storage conditions like 25C/60%RH for long term and 40C/75%RH for accelerated to see how they degrade. Parameters checked include dissolution, assay, and physical characteristics. Accelerated testing uses higher temperatures to rapidly degrade drugs and the Arrhenius equation to predict shelf life at normal temperatures based on degradation rates. Products are tested throughout their shelf life to ensure quality is maintained.
This document discusses pharmacovigilance and the role of consumers in reporting adverse drug reactions (ADRs) in India. It outlines how India established a pharmacovigilance program to monitor ADRs. Underreporting of ADRs by healthcare professionals is a limitation, so consumer reporting can help detect more ADRs earlier, especially for over-the-counter drugs. India has launched forms and a mobile app to facilitate consumer ADR reporting to strengthen pharmacovigilance. While consumer reporting cannot replace healthcare professional reporting, it can complement it.
This document discusses the development and validation of in vitro-in vivo correlations (IVIVCs) to establish mathematical relationships between drug dissolution rates in vitro and absorption rates in vivo. It presents an overview of IVIVC levels A, B and C and describes how to obtain in vivo pharmacokinetic data, analyze dissolution data, and correlate the two to establish each IVIVC level. Level A provides point-to-point correlation of entire dissolution and absorption profiles, level B correlates mean dissolution time in vitro to that in vivo, and level C relates a single pharmacokinetic parameter to dissolution at one time point.
This document discusses generics versus brand name anti-epileptic drugs (AEDs). It notes that generics have the same active ingredients and biological effects as brand names, but some concerns exist regarding their approval process and effects on certain populations like children and the elderly. While regulatory agencies say existing bioequivalence rules are adequate, both they and patient advocacy groups may be biased. The document concludes there is reason for concern about current generic regulations and advises doctors to track what medications patients receive and educate others to minimize risks of substituting generics.
คู่มือหลักเกณฑ์การขึ้นทะเบียนตำรับยาแผนโบราณ Guideline Registration Traditional Medicine โดยกลุ่มยาแผนไทยและยาสมุนไพร สำนักยา สำนักงานคณะกรรมการอาหารและยา กระทรวงสาธารณสุข
Stability testing evaluates how the quality of a drug varies over time under different environmental conditions like temperature and humidity. It establishes a re-test period for active ingredients and shelf life for products. Drugs are tested under various storage conditions like 25C/60%RH for long term and 40C/75%RH for accelerated to see how they degrade. Parameters checked include dissolution, assay, and physical characteristics. Accelerated testing uses higher temperatures to rapidly degrade drugs and the Arrhenius equation to predict shelf life at normal temperatures based on degradation rates. Products are tested throughout their shelf life to ensure quality is maintained.
This document discusses pharmacovigilance and the role of consumers in reporting adverse drug reactions (ADRs) in India. It outlines how India established a pharmacovigilance program to monitor ADRs. Underreporting of ADRs by healthcare professionals is a limitation, so consumer reporting can help detect more ADRs earlier, especially for over-the-counter drugs. India has launched forms and a mobile app to facilitate consumer ADR reporting to strengthen pharmacovigilance. While consumer reporting cannot replace healthcare professional reporting, it can complement it.
This document discusses the development and validation of in vitro-in vivo correlations (IVIVCs) to establish mathematical relationships between drug dissolution rates in vitro and absorption rates in vivo. It presents an overview of IVIVC levels A, B and C and describes how to obtain in vivo pharmacokinetic data, analyze dissolution data, and correlate the two to establish each IVIVC level. Level A provides point-to-point correlation of entire dissolution and absorption profiles, level B correlates mean dissolution time in vitro to that in vivo, and level C relates a single pharmacokinetic parameter to dissolution at one time point.
This document discusses generics versus brand name anti-epileptic drugs (AEDs). It notes that generics have the same active ingredients and biological effects as brand names, but some concerns exist regarding their approval process and effects on certain populations like children and the elderly. While regulatory agencies say existing bioequivalence rules are adequate, both they and patient advocacy groups may be biased. The document concludes there is reason for concern about current generic regulations and advises doctors to track what medications patients receive and educate others to minimize risks of substituting generics.
คู่มือมาตรฐานการผลิตยาสมุนไพร WHO guidelines on good manufacturing practices for herbal medicines สถาบันการแพทย์แผนไทย กรมการแพทย์แผนไทยและการแพทย์ทางเลือก กระทรวงสาธารณสุข
5. 12/09/54
ลกษณะสาคญของ
ISafE และ EMCI
1.Evidence based medicine
2.Transparent expert judgment
3.Comprehensive quality indicators
4.Multiplication system
5.Explicit scoring system
6.Cost assessment comparison
5
6. 12/09/54
advanced Pubmed search, TRIP
database, BMJ clinical evidence,
Cochrane library, Micromedex
Drugdex Drug Evaluation,
Evaluation
Micromedex Drug Interactions,
WHO Defined Daily Dose Website,
Clinical Pharmacology 2004 CD
ROM, M d
ROM Medscape Druginfo,
D i f
Physician Desk Reference (PDR),
Martindale และ BNF
1.Evidence based medicine
ตัวอยาง search strategy
ที่ใชคนใน Pubmed
Atenolol[MeSH] AND
"Migraine"[MeSH] AND
(Randomized Controlled
Trial[ptyp] OR Meta-
Meta-
Analysis[ptyp] OR Review,
Academic[ptyp])
1.Evidence based medicine
6
7. 12/09/54
ฐานขอมูล Micromedex
Drugdex Drug
Evaluation
ERYTHROPOIETINS
1.CLINICAL APPLICATIONS
2.THERAPEUTIC USES
3.C. ANEMIA - CHRONIC RENAL FAILURE
FDA Labeled Indication
1.1. OVERVIEW:
FDA APPROVAL: Adult, yes; pediatric, yes
EFFICACY: Adult, effective; pediatric, effective
Documentation: Adult, excellent;
pediatric, good
1.Evidence based medicine
7
11. 12/09/54
คะแนน ISafE
(คะแนนคุณลักษณะอันพึงประสงคของยา)
I=I f
Information
ti
S = Safety
a = administration restriction
compliance
f=f
frequency of administration
f d i i t ti
E = Efficacy
3.Comprehensive quality indicators
11
12. 12/09/54
คะแนน ISafE
(คะแนนคุณลักษณะอันพึงประสงคของยา)
Ibuprofen
Ib p ofen Celecoxib
Celeco ib
Information 0.90 0.90
Efficacy 1.00 1.00
Safety 0.90 0.90
Compliance 0.81 0.86
ISafE score 0.66 0.70
3.Comprehensive quality indicators
รายละเอียดการคํานวณ
คะแนน ISafE
Generic
Name EV I MM E RK S IES a f af ISafE
Oxybutynin 23GG 0.95 EE 1.00 M17C68 0.85 0.81 0.95 0.95 0.90 0.73
Tolterodine 17EF 0.85 EE 1.00 M13C68 0.90 0.77 1.00 0.95 0.95 0.72
Trospium 18GF 0.88 EP 0.95 Mn/aCn/a 1.00 0.84 0.95 0.95 0.90 0.72
Flavoxate 2GG 0.70
0 70 PP 0.90
0 90 M6C43 1.00
1 00 0.63
0 63 1.00
1 00 0.90
0 90 0.90
0 90 0.57
0 57
คะแนน 50 percentile = 0.72
3.Comprehensive quality indicators
12