Day 1 - US Pharmacopeial Convention

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• GENOMICS: GENOMICS “OMIC” BIOMARKERS : CHEMICAL CHEMICAL-SPECIFIC SPECIFIC ALTERATIONS IN GENE EXPRESSION PATTERNS IN TARGET CELL POPULATIONS • PROTEOMICS: PROTEOMICS : CHEMICAL CHEMICAL-SPECIFIC SPECIFIC ALTERATIONS IN THE ACTUAL EXPRESSION OF GENE PRODUCTS (PROTEINS) • METABOLOMICS/METABONOMICS: METABOLOMICS/METABONOMICS : CHEMICAL CHEMICAL- INDUCED ALTERATIONS IN IN ESSENTIAL ESSENTIAL BIOLOGICAL PATHWAYS WITH MEASUREMENT OF METABOLIC PRODUCTS / PRECURSORS IN ACCESSIBLE BODY FLUIDS (EG: URINE) BIOMARKER MODIFYING FACTORS • DOSE DOSE RESPONSE/TIME COURSE • EXPOSED POPULATION (AGE, GENDER, NUTRITIONAL STAT<strong>US</strong>, GENETIC S<strong>US</strong>CEPTIBILITY) • COMPENSATORY MECHANISMS (INDUCIBLE ENZYME SYSTEMS, METAL METAL-BINDING BINDING PROTEINS, STRESS PROTEINS) • ANTIOXIDANT SYSTEMS (E.G., GLUTATHIONE) 5
Page 1 and 2: Impurities, Adulteration, and the C
Page 3 and 4: A Fifteen Year Saga Begins � 1995
Page 5 and 6: Recent Activities � USP published
Page 7 and 8: Design and Scope of Chapters � Li
Page 9 and 10: Impurities and Limits - Current Pan
Page 11 and 12: Some Possible Scenarios Added to th
Page 13 and 14: Results of Team’s Experiments �
Page 15 and 16: Elemental Impurities-Procedures Qu
Page 17 and 18: Stimuli Article: Elemental Impuriti
Page 19 and 20: Acknowledgements Heavy Metals Advis
Page 21 and 22: TOXIC METALS / METALLOIDS REPORTED
Page 23: Chemical Exposures NHANES III BLOOD
Page 27 and 28: MECHANISM BASED BASED /MODE OF OF A
Page 32 and 33: INCIDENCE OF RENAL LEAD INTRANUCLEA
Page 34 and 35: EMERGING ISSUES •INCREASING LEVEL
Page 36 and 37: Need for testing of Metals in Pharm
Page 38 and 39: Torch Configurations • Radial (La
Page 40 and 41: LA-ICP-MS � Minimal / no sample p
Page 42 and 43: XRF • For true quantitation, appr
Page 44 and 45: Procedures 1 and 2 (ICP-OES and ICP
Page 46 and 47: Regulating Elemental Impurities in
Page 48 and 49: Introduction Impurities are unwante
Page 50 and 51: Specification of Heavy Metals Heavy
Page 52 and 53: Controls on Heavy Metals (HM) & Lea
Page 54 and 55: Controls on Heavy Metals (HM): USP
Page 56 and 57: Quantifying Toxicity • Non-cancer
Page 58 and 59: Dose Estimate of Toxic Effects LD50
Page 60 and 61: RReference f D Dose (RfD) ( (cont.)
Page 62 and 63: Migration of Lead into Food or Drug
Page 64 and 65: DDeliberate lib t Ad Adulteration l
Page 66 and 67: Analysis of dietary supplements for
Page 68 and 69: Blood Lead Levels less than 5 µg/d
Page 70 and 71: [ Pirkle et al, 1985 ] 25
Page 72 and 73: Lead RfD • NOAEL = Lead is a no t
Page 74 and 75:
Th Three Forms F of f Mercury M Ele
Page 76 and 77:
Mercury: Toxicity • Methyl y merc
Page 78 and 79:
Mercury RfD • The presence p of m
Page 81 and 82:
• NOAEL = 0.8 µg/kg/day Arsenic
Page 83 and 84:
Target Organs of Itai-Itai Disease
Page 85 and 86:
• Platinum • Iridium • Rhodiu
Page 87 and 88:
Proposed Limits (Oral) Elements USP
Page 89 and 90:
Points to consider: What metals to
Page 91:
CCurrent S Status/Recommendation/s
Page 94 and 95:
The Pharmacopeia of the United Stat
Page 96 and 97:
Building Blocks of USP Biological S
Page 98 and 99:
Identification - Example 1: Insulin
Page 100 and 101:
Assay - Amount of Substance or Acti
Page 102 and 103:
Conclusions • A pharmacopeial mon
Page 104 and 105:
Characterisation of Heparin; Recent
Page 106 and 107:
Heparin structure • Heparin is a
Page 108 and 109:
Why is it dangerous? • The mechan
Page 110 and 111:
NMR spectroscopy - 1D 1D 1 H NMR ca
Page 112 and 113:
Specific anticoagulant activities,
Page 114 and 115:
Methods Extracted contaminant from
Page 116 and 117:
Conclusions (1) • Our evidence in
Page 118 and 119:
DEG, EG and the Compendia’s Role
Page 120 and 121:
USP Response to Haiti incident for
Page 122 and 123:
21 CFR Part 211 - CGMP Requirements
Page 124 and 125:
Monograph modernization of “High-
Page 126 and 127:
USP Monograph modernization efforts
Page 128 and 129:
Rx-360 An International Pharmaceuti
Page 130 and 131:
Rx-360 Mission Create and monitor a
Page 132 and 133:
Since April 2009 Rx-360 Has Distrib
Page 134 and 135:
Sharing Supplier Audits Will Increa
Page 136 and 137:
Common sense dictates that you do b
Page 138 and 139:
There are many new ideas that can b
Page 140 and 141:
New technologies are being implemen
Page 142 and 143:
We Must Act Now � There is a sign
Page 144 and 145:
Recent Health Canada Activities Rel
Page 146 and 147:
Review of Canadian Adverse Reaction
Page 148 and 149:
Product: Black Cohosh Samples of Sa
Page 150 and 151:
Mobile phase: Method (cont’d) A :
Page 152 and 153:
17 18 9
Page 154 and 155:
Discussion Important considerations
Page 156 and 157:
Recommendations Recommendation #1
Page 158 and 159:
Actions by the Regulator in Respons
Page 160 and 161:
Actions by the Regulator in Respons
Page 162 and 163:
Thank you! Pauline.lacroix@hc-sc.gc
Page 164 and 165:
Ⅰ Focus on the safety of TCM qual
Page 166 and 167:
Control methods on pesticide residu
Page 168 and 169:
Strengthen the material basis of TC
Page 170 and 171:
Extractum Forsythiae Siccus still e
Page 172 and 173:
glc-O Peak identified in the finger
Page 174 and 175:
Source investigation and identifica
Page 176 and 177:
The method development of soluble a
Page 178 and 179:
Factors affecting the analysis,and
Page 180 and 181:
content(%) 8 6 4 2 0 Study on corre
Page 182 and 183:
Thank you for your attention! Your
Page 184 and 185:
Origins and Spread of Drug Chloroqu
Page 186 and 187:
Slide 6 m2 This slide is set to tra
Page 188 and 189:
Artemesinin Compound QAMSA Study Ar
Page 190 and 191:
Medicines are not ordinary commodit
Page 192 and 193:
PMS-Testing Methods Used in Field G
Page 194 and 195:
Case Study #2: Ghana � Sites sele
Page 196 and 197:
PQM Staff Where we’re from: Argen
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Day 1 - US Pharmacopeial Convention

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